Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-05 @ 3:50 AM
Study NCT ID:
NCT00329420
Status:
COMPLETED
Last Update Posted:
2015-03-18
First Post:
2006-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (NCT00291668)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068582', 'term': 'Certolizumab Pegol'}], 'ancestors': [{'id': 'D011092', 'term': 'Polyethylene Glycols'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D007140', 'term': 'Immunoglobulin Fab Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+1 877 822 9493', 'title': 'UCB Clinical Trial Call Center', 'organization': 'UCB Pharma'}, 'certainAgreement': {'otherDetails': 'UCB has \\> 60 days but \\<= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to the small number of subjects in this study, the percentages of subjects with adverse events may be misleading.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data summarized in the first four columns were collected from the day after the end of the double-blind main study up to and including 12 weeks following the last dose received in this extension study for each subject (i.e., up to 36 weeks).', 'description': "For the fifth column, 'Total 2', this presents the data summarized in 'Total 1' PLUS adverse event data from the double-blind main study for subjects who received certolizumab pegol (CZP) in the main study and then entered this extension study (i.e., up to 44 weeks).", 'eventGroups': [{'id': 'EG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)', 'otherNumAtRisk': 18, 'otherNumAffected': 15, 'seriousNumAtRisk': 18, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)', 'otherNumAtRisk': 13, 'otherNumAffected': 10, 'seriousNumAtRisk': 13, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)', 'otherNumAtRisk': 15, 'otherNumAffected': 13, 'seriousNumAtRisk': 15, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Total 1 (This Extension Study Only)', 'description': 'This includes all adverse event data collected in this extension study for all 46 subjects who entered this extension study.', 'otherNumAtRisk': 46, 'otherNumAffected': 38, 'seriousNumAtRisk': 46, 'seriousNumAffected': 8}, {'id': 'EG004', 'title': 'Total 2 (Treatment With CZP in Main Study and Extension Study)', 'description': 'This includes all adverse event data from the 6-week double-blind main study (N00291668) and this extension study for all 46 subjects who entered this extension study C87048, whilst they were receiving treatment with certolizumab pegol (CZP) in either study. Adverse events recorded in the double-blind main study (NCT00291668) for subjects who received Placebo treatment during that study are not included here.', 'otherNumAtRisk': 46, 'otherNumAffected': 40, 'seriousNumAtRisk': 46, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Blood calcium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'DNA antibody positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Depressive symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Eczema asteatotic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Emotional distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Gastroduodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 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{'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Osteomalacia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, 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'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Tetany', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 34", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of CDAI responders', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of CDAI non-responders', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}, {'value': '57.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Non-responders at Week 6 of main study C87037 (NCT00291668) could enter this extension study, C87048 (NCT00329420). This summary is based on the 26 subjects in the Full Analysis Set (FAS) Population who responded to re-induction at Week 14. Subject withdrawal or use of rescue therapy is counted as non-response from that time onwards in that study.'}, {'type': 'SECONDARY', 'title': "Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.5', 'spread': '81.6', 'groupId': 'OG000'}, {'value': '-53.1', 'spread': '38.1', 'groupId': 'OG001'}, {'value': '-63.8', 'spread': '26.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. All those in this subgroup with data are included in this summary.'}, {'type': 'SECONDARY', 'title': "Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 10", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '-96.1', 'spread': '76.1', 'groupId': 'OG000'}, {'value': '-100.3', 'spread': '35.4', 'groupId': 'OG001'}, {'value': '-90.0', 'spread': '18.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. All those in this subgroup with data are included in this summary.'}, {'type': 'SECONDARY', 'title': "Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '-101.3', 'spread': '56.6', 'groupId': 'OG000'}, {'value': '-100.5', 'spread': '49.3', 'groupId': 'OG001'}, {'value': '-109.9', 'spread': '36.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. All those in this subgroup with data are included in this summary.'}, {'type': 'SECONDARY', 'title': "Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 14", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '-124.3', 'spread': '50.4', 'groupId': 'OG000'}, {'value': '-131.7', 'spread': '41.3', 'groupId': 'OG001'}, {'value': '-147.0', 'spread': '45.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. All those in this subgroup with data are included in this summary.'}, {'type': 'SECONDARY', 'title': "Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 16", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '-121.0', 'spread': '57.7', 'groupId': 'OG000'}, {'value': '-70.4', 'spread': '84.1', 'groupId': 'OG001'}, {'value': '-136.2', 'spread': '32.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. All those in this subgroup with data are included in this summary.'}, {'type': 'SECONDARY', 'title': "Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20", 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '-105.3', 'spread': '82.9', 'groupId': 'OG000'}, {'value': '-79.6', 'spread': '60.9', 'groupId': 'OG001'}, {'value': '-130.9', 'spread': '62.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. All those in this subgroup with data are included in this summary.'}, {'type': 'SECONDARY', 'title': "Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 24", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '-89.8', 'spread': '79.8', 'groupId': 'OG000'}, {'value': '-70.6', 'spread': '91.3', 'groupId': 'OG001'}, {'value': '-150.2', 'spread': '48.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. All those in this subgroup with data are included in this summary.'}, {'type': 'SECONDARY', 'title': "Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 28", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '-118.2', 'spread': '62.6', 'groupId': 'OG000'}, {'value': '-67.3', 'spread': '77.1', 'groupId': 'OG001'}, {'value': '-154.8', 'spread': '74.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. All those in this subgroup with data are included in this summary.'}, {'type': 'SECONDARY', 'title': "Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 32", 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '-89.0', 'spread': '88.3', 'groupId': 'OG000'}, {'value': '-77.3', 'spread': '70.9', 'groupId': 'OG001'}, {'value': '-128.3', 'spread': '75.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. All those in this subgroup with data are included in this summary.'}, {'type': 'SECONDARY', 'title': "Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 34", 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '-134.9', 'spread': '39.3', 'groupId': 'OG000'}, {'value': '-97.4', 'spread': '33.1', 'groupId': 'OG001'}, {'value': '-132.7', 'spread': '89.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. All those in this subgroup with data are included in this summary.'}, {'type': 'SECONDARY', 'title': "Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '-112.0', 'spread': '75.6', 'groupId': 'OG000'}, {'value': '-61.0', 'spread': '93.7', 'groupId': 'OG001'}, {'value': '-132.7', 'spread': '89.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. All those in this subgroup with data are included in this summary.'}, {'type': 'SECONDARY', 'title': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of CDAI responders', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of CDAI non-responders', 'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000'}, {'value': '85.7', 'groupId': 'OG001'}, {'value': '85.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.'}, {'type': 'SECONDARY', 'title': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of CDAI responders', 'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of CDAI non-responders', 'categories': [{'measurements': [{'value': '58.3', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '57.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.'}, {'type': 'SECONDARY', 'title': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of CDAI responders', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}, {'value': '57.1', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of CDAI non-responders', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.'}, {'type': 'SECONDARY', 'title': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 14", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of CDAI responders', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of CDAI non-responders', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.'}, {'type': 'SECONDARY', 'title': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of CDAI responders', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '42.9', 'groupId': 'OG001'}, {'value': '85.7', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of CDAI non-responders', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '57.1', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.'}, {'type': 'SECONDARY', 'title': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of CDAI responders', 'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '85.7', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of CDAI non-responders', 'categories': [{'measurements': [{'value': '58.3', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.'}, {'type': 'SECONDARY', 'title': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of CDAI responders', 'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG000'}, {'value': '57.1', 'groupId': 'OG001'}, {'value': '71.4', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of CDAI non-responders', 'categories': [{'measurements': [{'value': '58.3', 'groupId': 'OG000'}, {'value': '42.9', 'groupId': 'OG001'}, {'value': '28.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.'}, {'type': 'SECONDARY', 'title': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 28", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of CDAI responders', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '57.1', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of CDAI non-responders', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.'}, {'type': 'SECONDARY', 'title': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 32", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of CDAI responders', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '57.1', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of CDAI non-responders', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.'}, {'type': 'SECONDARY', 'title': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of CDAI responders', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of CDAI non-responders', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}, {'value': '57.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving Remission at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of subjects in remission', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of subjects not in remission', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '85.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving Remission at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of subjects in remission', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '42.9', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of subjects not in remission', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '57.1', 'groupId': 'OG001'}, {'value': '85.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving Remission at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of subjects in remission', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '42.9', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of subjects not in remission', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '57.1', 'groupId': 'OG001'}, {'value': '57.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving Remission at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of subjects in remission', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}, {'value': '71.4', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of subjects not in remission', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '28.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving Remission at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of subjects in remission', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '57.1', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of subjects not in remission', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving Remission at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of subjects in remission', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '57.1', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of subjects not in remission', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving Remission at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of subjects in remission', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '42.9', 'groupId': 'OG001'}, {'value': '71.4', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of subjects not in remission', 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000'}, {'value': '57.1', 'groupId': 'OG001'}, {'value': '28.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving Remission at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of subjects in remission', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '57.1', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of subjects not in remission', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving Remission at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of subjects in remission', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of subjects not in remission', 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}, {'value': '57.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving Remission at Week 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of subjects in remission', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of subjects not in remission', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}, {'value': '57.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving Remission at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of subjects in remission', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of subjects not in remission', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}, {'value': '57.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.'}, {'type': 'SECONDARY', 'title': 'Time to Disease Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'timeFrame': "Week 14 to Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is the visit at which response to re-induction is assessed and 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': "Time to disease progression is defined as the earliest of:\n\n* time to an increase from Week 14 of ≥100 points in Crohn's Disease Activity Index (CDAI) score and CDAI\\>175 points for at least 2 consecutive visits,\n* time to use of rescue therapy, or,\n* time to subject withdrawal from the study.", 'reportingStatus': 'POSTED', 'populationDescription': 'Non-responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study, C87048 (NCT00329420). As so few subjects experienced disease progression in this study it was not possible to calculate the median time to disease progression. Please see outcome measure 124 where the number of subjects with disease progression is presented.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '15.3', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '7.5', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '13.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.", 'description': 'The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '17.0', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '20.9', 'spread': '24.9', 'groupId': 'OG001'}, {'value': '15.1', 'spread': '13.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.", 'description': 'The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '17.3', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '26.3', 'spread': '33.6', 'groupId': 'OG001'}, {'value': '20.1', 'spread': '16.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.", 'description': 'The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '20.1', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '28.6', 'spread': '22.9', 'groupId': 'OG001'}, {'value': '26.3', 'spread': '16.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.", 'description': 'The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '16.3', 'spread': '12.2', 'groupId': 'OG000'}, {'value': '15.3', 'spread': '19.1', 'groupId': 'OG001'}, {'value': '20.0', 'spread': '16.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.", 'description': 'The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '12.2', 'spread': '16.0', 'groupId': 'OG000'}, {'value': '18.4', 'spread': '27.5', 'groupId': 'OG001'}, {'value': '15.9', 'spread': '14.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.", 'description': 'The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'spread': '14.5', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '23.3', 'groupId': 'OG001'}, {'value': '18.4', 'spread': '18.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.", 'description': 'The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'spread': '20.0', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '24.3', 'groupId': 'OG001'}, {'value': '15.9', 'spread': '19.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.", 'description': 'The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '11.2', 'spread': '21.7', 'groupId': 'OG001'}, {'value': '25.3', 'spread': '17.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.", 'description': 'The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '21.6', 'spread': '16.9', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '23.6', 'groupId': 'OG001'}, {'value': '20.6', 'spread': '17.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': 'The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '15.6', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '23.3', 'groupId': 'OG001'}, {'value': '20.6', 'spread': '17.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': 'The Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '5.6', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '5.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.", 'description': 'The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '10.6', 'spread': '8.4', 'groupId': 'OG001'}, {'value': '5.9', 'spread': '7.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.", 'description': 'The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '11.7', 'spread': '9.7', 'groupId': 'OG001'}, {'value': '7.4', 'spread': '7.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.", 'description': 'The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '9.3', 'groupId': 'OG001'}, {'value': '9.3', 'spread': '7.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.", 'description': 'The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '9.9', 'groupId': 'OG001'}, {'value': '6.3', 'spread': '7.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.", 'description': 'The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '11.7', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '5.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.", 'description': 'The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '11.0', 'groupId': 'OG001'}, {'value': '5.6', 'spread': '8.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.", 'description': 'The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '10.0', 'groupId': 'OG001'}, {'value': '5.4', 'spread': '8.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.", 'description': 'The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '11.0', 'groupId': 'OG001'}, {'value': '7.5', 'spread': '5.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.", 'description': 'The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '9.8', 'groupId': 'OG001'}, {'value': '5.8', 'spread': '6.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': 'The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '12.2', 'groupId': 'OG001'}, {'value': '5.8', 'spread': '6.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': 'The Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.", 'description': 'The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '6.2', 'groupId': 'OG001'}, {'value': '3.9', 'spread': '1.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.", 'description': 'The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '7.3', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '2.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.", 'description': 'The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '4.3', 'groupId': 'OG001'}, {'value': '6.3', 'spread': '3.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.", 'description': 'The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '3.7', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '3.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.", 'description': 'The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '6.3', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '2.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.", 'description': 'The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '5.9', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '2.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.", 'description': 'The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '5.8', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '3.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.", 'description': 'The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '3.1', 'groupId': 'OG001'}, {'value': '6.8', 'spread': '3.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.", 'description': 'The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '4.8', 'groupId': 'OG001'}, {'value': '5.4', 'spread': '2.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': 'The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '4.4', 'groupId': 'OG001'}, {'value': '5.4', 'spread': '2.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': 'The Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '6.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.", 'description': 'The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '9.7', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '5.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.", 'description': 'The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '13.8', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '6.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.", 'description': 'The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '10.3', 'groupId': 'OG001'}, {'value': '6.7', 'spread': '8.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.", 'description': 'The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '6.2', 'groupId': 'OG001'}, {'value': '6.0', 'spread': '8.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.", 'description': 'The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '10.7', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '6.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.", 'description': 'The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '5.7', 'groupId': 'OG001'}, {'value': '6.1', 'spread': '7.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.", 'description': 'The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '8.0', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '7.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.", 'description': 'The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '6.1', 'groupId': 'OG001'}, {'value': '7.7', 'spread': '9.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.", 'description': 'The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '8.6', 'groupId': 'OG001'}, {'value': '6.4', 'spread': '10.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': 'The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '7.9', 'groupId': 'OG001'}, {'value': '6.4', 'spread': '10.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': 'The Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '3.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.", 'description': 'The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '4.7', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '3.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.", 'description': 'The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '5.1', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '4.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.", 'description': 'The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '2.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.", 'description': 'The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '3.9', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '2.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.", 'description': 'The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '3.0', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '2.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.", 'description': 'The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '4.9', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '2.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.", 'description': 'The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '4.6', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '3.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.", 'description': 'The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '2.9', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '2.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.", 'description': 'The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '3.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': 'The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '4.5', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '3.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': 'The Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein (CRP) Level at Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '19.58', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '60.0'}, {'value': '14.97', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '25.0'}, {'value': '26.45', 'groupId': 'OG002', 'lowerLimit': '16.0', 'upperLimit': '50.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Week 0 (relative to the start of the 6-week double-blind main study (N00291668)). 'Week 0' is the Baseline visit in the double-blind main study.", 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein (CRP) Level at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '22.06', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '76.0'}, {'value': '11.91', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '41.0'}, {'value': '16.70', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '55.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.", 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein (CRP) Level at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '7.76', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '40.0'}, {'value': '5.62', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '13.0'}, {'value': '12.01', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '34.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.", 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein (CRP) Level at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '7.82', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '31.0'}, {'value': '7.06', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '14.0'}, {'value': '13.39', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '54.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.", 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein (CRP) Level at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '9.57', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '32.0'}, {'value': '6.32', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '14.0'}, {'value': '15.30', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '41.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.", 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein (CRP) Level at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '12.54', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '35.0'}, {'value': '12.23', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '45.0'}, {'value': '15.10', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '36.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.", 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein (CRP) Level at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '12.27', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '74.0'}, {'value': '13.24', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '50.0'}, {'value': '14.99', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '53.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.", 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein (CRP) Level at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '9.11', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '45.0'}, {'value': '14.16', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '33.0'}, {'value': '15.70', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '38.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.", 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein (CRP) Level at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '8.79', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '24.0'}, {'value': '14.25', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '40.0'}, {'value': '26.81', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '33.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.", 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein (CRP) Level at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '15.28', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '45.0'}, {'value': '10.27', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '24.0'}, {'value': '16.71', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '48.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.", 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein (CRP) Level at Week 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '9.19', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '40.0'}, {'value': '6.23', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '16.0'}, {'value': '23.52', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '81.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.", 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein (CRP) Level at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '11.25', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '75.0'}, {'value': '8.46', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '39.0'}, {'value': '23.52', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '81.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.", 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Ratio of C-Reactive Protein (CRP) Level at Week 8 to CRP Level at Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.13', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '4.3'}, {'value': '0.80', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '4.1'}, {'value': '0.63', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '3.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.", 'description': 'The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 8 divided by the CRP Level at Week 0', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Ratio of C-Reactive Protein (CRP) Level at Week 10 to CRP Level at Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '1.5'}, {'value': '0.38', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '1.2'}, {'value': '0.45', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '2.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.", 'description': 'The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 10 divided by the CRP Level at Week 0', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Ratio of C-Reactive Protein (CRP) Level at Week 12 to CRP Level at Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '2.0'}, {'value': '0.47', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '1.1'}, {'value': '0.51', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '3.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.", 'description': 'The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 12 divided by the CRP Level at Week 0', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Ratio of C-Reactive Protein (CRP) Level at Week 14 to CRP Level at Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.49', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '5.0'}, {'value': '0.42', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '1.0'}, {'value': '0.58', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '2.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.", 'description': 'The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 14 divided by the CRP Level at Week 0', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Ratio of C-Reactive Protein (CRP) Level at Week 16 to CRP Level at Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.64', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '5.3'}, {'value': '0.82', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '4.1'}, {'value': '0.57', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '2.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.", 'description': 'The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 16 divided by the CRP Level at Week 0', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Ratio of C-Reactive Protein (CRP) Level at Week 20 to CRP Level at Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.64', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '0.88', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '4.5'}, {'value': '0.57', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.", 'description': 'The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 20 divided by the CRP Level at Week 0', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Ratio of C-Reactive Protein (CRP) Level at Week 24 to CRP Level at Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.48', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.5'}, {'value': '0.95', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '2.4'}, {'value': '0.59', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.", 'description': 'The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 24 divided by the CRP Level at Week 0', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Ratio of C-Reactive Protein (CRP) Level at Week 28 to CRP Level at Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.46', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.8'}, {'value': '0.95', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '2.7'}, {'value': '1.06', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '2.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.", 'description': 'The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 28 divided by the CRP Level at Week 0', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Ratio of C-Reactive Protein (CRP) Level at Week 32 to CRP Level at Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '4.6'}, {'value': '0.64', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '1.2'}, {'value': '0.62', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.", 'description': 'The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 32 divided by the CRP Level at Week 0', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Ratio of C-Reactive Protein (CRP) Level at Week 34 to CRP Level at Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.54', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.8'}, {'value': '0.39', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '1.6'}, {'value': '1.07', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '3.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': 'The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 34 divided by the CRP Level at Week 0', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': 'Ratio of C-Reactive Protein (CRP) Level at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) to CRP Level at Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.59', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.8'}, {'value': '0.54', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '2.8'}, {'value': '1.07', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '3.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': 'The ratio is calculated as the C-Reactive Protein (CRP) Level at Last Visit (Week 34 for completers or the Withdrawal Visit for premature withdrawals)divided by the CRP Level at Week 0', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.'}, {'type': 'SECONDARY', 'title': "Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 8", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of 70-point responders', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of 70-point non-responders', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}, {'value': '57.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.", 'description': "70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study.'}, {'type': 'SECONDARY', 'title': "Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 10", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of 70-point responders', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '85.7', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of 70-point non-responders', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.", 'description': "70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study.'}, {'type': 'SECONDARY', 'title': "Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of 70-point responders', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}, {'value': '85.7', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of 70-point non-responders', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.", 'description': "70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study.'}, {'type': 'SECONDARY', 'title': "Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 14", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of 70-point responders', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of 70-point non-responders', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.", 'description': "70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study.'}, {'type': 'SECONDARY', 'title': "Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 16", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of 70-point responders', 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000'}, {'value': '57.1', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of 70-point non-responders', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '42.9', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.", 'description': "70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study.'}, {'type': 'SECONDARY', 'title': "Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 20", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of 70-point responders', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}, {'value': '85.7', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of 70-point non-responders', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.", 'description': "70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study.'}, {'type': 'SECONDARY', 'title': "Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 24", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of 70-point responders', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of 70-point non-responders', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.", 'description': "70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study.'}, {'type': 'SECONDARY', 'title': "Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 28", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of 70-point responders', 'categories': [{'measurements': [{'value': '58.3', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}, {'value': '85.7', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of 70-point non-responders', 'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.", 'description': "70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study.'}, {'type': 'SECONDARY', 'title': "Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 32", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of 70-point responders', 'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG000'}, {'value': '57.1', 'groupId': 'OG001'}, {'value': '57.1', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of 70-point non-responders', 'categories': [{'measurements': [{'value': '58.3', 'groupId': 'OG000'}, {'value': '42.9', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.", 'description': "70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study.'}, {'type': 'SECONDARY', 'title': "Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 34", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of 70-point responders', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '42.9', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of 70-point non-responders', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '57.1', 'groupId': 'OG001'}, {'value': '57.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': "70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study.'}, {'type': 'SECONDARY', 'title': "Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'title': 'Percentage of 70-point responders', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '42.9', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of 70-point non-responders', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '57.1', 'groupId': 'OG001'}, {'value': '57.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': "70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study.'}, {'type': 'POST_HOC', 'title': 'Number of Subjects With Disease Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'OG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 14 to Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is the visit at which response to re-induction is assessed and 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': "Disease progression is defined as:\n\n* an increase from Week 14 of ≥100 points in Crohn's Disease Activity Index (CDAI) score and CDAI\\>175 points for at least 2 consecutive visits,\n* use of rescue therapy, or,\n* subject withdrawal from the study.", 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Non-responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study C87048 (NCT00329420). As it was not possible to calculate the time to disease progression (outcome measure 34) due to the very small number of subjects meeting this definition, the post-hoc outcome of number of subjects with disease progression is presented here'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'FG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'FG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}], 'periods': [{'title': 'Re-induction Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed = Reached Week 14 (end of re-induction phase) and responded to re-induction at that time.', 'groupId': 'FG000', 'numSubjects': '12'}, {'comment': 'Completed = Reached Week 14 (end of re-induction phase) and responded to re-induction at that time.', 'groupId': 'FG001', 'numSubjects': '7'}, {'comment': 'Completed = Reached Week 14 (end of re-induction phase) and responded to re-induction at that time.', 'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Did not respond to re-induction', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}]}]}, {'title': '4-weekly Dosing Phase (Responders Only)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Non-responders at Week 6 of the double-blind main study, C87037 (NCT00291668) could enter this single-group open-label extension study, C87048 (NCT00329420). Recruitment into this extension study was between May 2006 and May 2008. Of the 26 hospitals in the main study (NCT00291668), 16 sites went on to enter subjects into this extension study.', 'preAssignmentDetails': 'Subjects who responded to re-induction (Week 14 visit) in this extension study could enter the 4-weekly dosing phase. Efficacy data are based on these 26 subjects. However, adverse event data are based on all 46 subjects who entered this extension study. Data are presented by the three possible treatment sequences received across both studies.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'BG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'BG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.4', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '37.5', 'spread': '8.2', 'groupId': 'BG001'}, {'value': '29.9', 'spread': '5.9', 'groupId': 'BG002'}, {'value': '32.2', 'spread': '7.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-27', 'studyFirstSubmitDate': '2006-05-22', 'resultsFirstSubmitDate': '2009-05-01', 'studyFirstSubmitQcDate': '2006-05-22', 'lastUpdatePostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-09-25', 'studyFirstPostDateStruct': {'date': '2006-05-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 34", 'timeFrame': "Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}], 'secondaryOutcomes': [{'measure': "Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8", 'timeFrame': "Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity."}, {'measure': "Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 10", 'timeFrame': "Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity."}, {'measure': "Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 12", 'timeFrame': "Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity."}, {'measure': "Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 14", 'timeFrame': "Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity."}, {'measure': "Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 16", 'timeFrame': "Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity."}, {'measure': "Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20", 'timeFrame': "Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity."}, {'measure': "Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 24", 'timeFrame': "Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity."}, {'measure': "Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 28", 'timeFrame': "Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity."}, {'measure': "Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 32", 'timeFrame': "Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity."}, {'measure': "Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 34", 'timeFrame': "Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity."}, {'measure': "Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)", 'timeFrame': "Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity."}, {'measure': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8", 'timeFrame': "Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10", 'timeFrame': "Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12", 'timeFrame': "Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 14", 'timeFrame': "Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16", 'timeFrame': "Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20", 'timeFrame': "Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24", 'timeFrame': "Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 28", 'timeFrame': "Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 32", 'timeFrame': "Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)", 'timeFrame': "Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': 'Percentage of Subjects Achieving Remission at Week 8', 'timeFrame': "Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': 'Percentage of Subjects Achieving Remission at Week 10', 'timeFrame': "Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': 'Percentage of Subjects Achieving Remission at Week 12', 'timeFrame': "Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': 'Percentage of Subjects Achieving Remission at Week 14', 'timeFrame': "Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': 'Percentage of Subjects Achieving Remission at Week 16', 'timeFrame': "Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': 'Percentage of Subjects Achieving Remission at Week 20', 'timeFrame': "Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': 'Percentage of Subjects Achieving Remission at Week 24', 'timeFrame': "Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': 'Percentage of Subjects Achieving Remission at Week 28', 'timeFrame': "Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': 'Percentage of Subjects Achieving Remission at Week 32', 'timeFrame': "Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': 'Percentage of Subjects Achieving Remission at Week 34', 'timeFrame': "Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': 'Percentage of Subjects Achieving Remission at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)', 'timeFrame': "Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': "Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': 'Time to Disease Progression', 'timeFrame': "Week 14 to Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is the visit at which response to re-induction is assessed and 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': "Time to disease progression is defined as the earliest of:\n\n* time to an increase from Week 14 of ≥100 points in Crohn's Disease Activity Index (CDAI) score and CDAI\\>175 points for at least 2 consecutive visits,\n* time to use of rescue therapy, or,\n* time to subject withdrawal from the study."}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 8', 'timeFrame': "Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.", 'description': 'The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 10', 'timeFrame': "Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.", 'description': 'The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 12', 'timeFrame': "Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.", 'description': 'The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 14', 'timeFrame': "Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.", 'description': 'The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 16', 'timeFrame': "Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.", 'description': 'The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 20', 'timeFrame': "Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.", 'description': 'The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 24', 'timeFrame': "Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.", 'description': 'The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 28', 'timeFrame': "Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.", 'description': 'The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 32', 'timeFrame': "Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.", 'description': 'The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 34', 'timeFrame': "Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': 'The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)', 'timeFrame': "Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': 'The Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 8', 'timeFrame': "Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.", 'description': 'The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 10', 'timeFrame': "Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.", 'description': 'The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 12', 'timeFrame': "Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.", 'description': 'The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 14', 'timeFrame': "Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.", 'description': 'The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 16', 'timeFrame': "Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.", 'description': 'The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 20', 'timeFrame': "Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.", 'description': 'The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 24', 'timeFrame': "Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.", 'description': 'The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 28', 'timeFrame': "Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.", 'description': 'The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 32', 'timeFrame': "Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.", 'description': 'The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 34', 'timeFrame': "Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': 'The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)', 'timeFrame': "Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': 'The Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 8', 'timeFrame': "Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.", 'description': 'The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 10', 'timeFrame': "Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.", 'description': 'The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 12', 'timeFrame': "Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.", 'description': 'The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 14', 'timeFrame': "Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.", 'description': 'The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 16', 'timeFrame': "Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.", 'description': 'The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 20', 'timeFrame': "Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.", 'description': 'The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 24', 'timeFrame': "Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.", 'description': 'The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 28', 'timeFrame': "Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.", 'description': 'The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 32', 'timeFrame': "Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.", 'description': 'The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 34', 'timeFrame': "Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': 'The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)', 'timeFrame': "Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': 'The Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 8', 'timeFrame': "Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.", 'description': 'The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 10', 'timeFrame': "Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.", 'description': 'The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 12', 'timeFrame': "Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.", 'description': 'The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 14', 'timeFrame': "Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.", 'description': 'The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 16', 'timeFrame': "Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.", 'description': 'The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 20', 'timeFrame': "Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.", 'description': 'The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 24', 'timeFrame': "Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.", 'description': 'The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 28', 'timeFrame': "Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.", 'description': 'The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 32', 'timeFrame': "Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.", 'description': 'The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 34', 'timeFrame': "Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': 'The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)', 'timeFrame': "Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': 'The Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 8', 'timeFrame': "Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.", 'description': 'The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 10', 'timeFrame': "Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.", 'description': 'The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 12', 'timeFrame': "Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.", 'description': 'The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 14', 'timeFrame': "Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.", 'description': 'The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 16', 'timeFrame': "Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.", 'description': 'The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 20', 'timeFrame': "Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.", 'description': 'The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 24', 'timeFrame': "Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.", 'description': 'The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 28', 'timeFrame': "Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.", 'description': 'The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 32', 'timeFrame': "Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.", 'description': 'The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 34', 'timeFrame': "Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': 'The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)', 'timeFrame': "Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': 'The Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.'}, {'measure': 'C-Reactive Protein (CRP) Level at Week 0', 'timeFrame': "Week 0 (relative to the start of the 6-week double-blind main study (N00291668)). 'Week 0' is the Baseline visit in the double-blind main study."}, {'measure': 'C-Reactive Protein (CRP) Level at Week 8', 'timeFrame': "Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study."}, {'measure': 'C-Reactive Protein (CRP) Level at Week 10', 'timeFrame': "Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study."}, {'measure': 'C-Reactive Protein (CRP) Level at Week 12', 'timeFrame': "Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study."}, {'measure': 'C-Reactive Protein (CRP) Level at Week 14', 'timeFrame': "Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study."}, {'measure': 'C-Reactive Protein (CRP) Level at Week 16', 'timeFrame': "Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study."}, {'measure': 'C-Reactive Protein (CRP) Level at Week 20', 'timeFrame': "Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study."}, {'measure': 'C-Reactive Protein (CRP) Level at Week 24', 'timeFrame': "Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study."}, {'measure': 'C-Reactive Protein (CRP) Level at Week 28', 'timeFrame': "Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study."}, {'measure': 'C-Reactive Protein (CRP) Level at Week 32', 'timeFrame': "Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study."}, {'measure': 'C-Reactive Protein (CRP) Level at Week 34', 'timeFrame': "Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study."}, {'measure': 'C-Reactive Protein (CRP) Level at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)', 'timeFrame': "Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study."}, {'measure': 'Ratio of C-Reactive Protein (CRP) Level at Week 8 to CRP Level at Week 0', 'timeFrame': "Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.", 'description': 'The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 8 divided by the CRP Level at Week 0'}, {'measure': 'Ratio of C-Reactive Protein (CRP) Level at Week 10 to CRP Level at Week 0', 'timeFrame': "Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.", 'description': 'The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 10 divided by the CRP Level at Week 0'}, {'measure': 'Ratio of C-Reactive Protein (CRP) Level at Week 12 to CRP Level at Week 0', 'timeFrame': "Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.", 'description': 'The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 12 divided by the CRP Level at Week 0'}, {'measure': 'Ratio of C-Reactive Protein (CRP) Level at Week 14 to CRP Level at Week 0', 'timeFrame': "Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.", 'description': 'The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 14 divided by the CRP Level at Week 0'}, {'measure': 'Ratio of C-Reactive Protein (CRP) Level at Week 16 to CRP Level at Week 0', 'timeFrame': "Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.", 'description': 'The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 16 divided by the CRP Level at Week 0'}, {'measure': 'Ratio of C-Reactive Protein (CRP) Level at Week 20 to CRP Level at Week 0', 'timeFrame': "Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.", 'description': 'The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 20 divided by the CRP Level at Week 0'}, {'measure': 'Ratio of C-Reactive Protein (CRP) Level at Week 24 to CRP Level at Week 0', 'timeFrame': "Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.", 'description': 'The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 24 divided by the CRP Level at Week 0'}, {'measure': 'Ratio of C-Reactive Protein (CRP) Level at Week 28 to CRP Level at Week 0', 'timeFrame': "Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.", 'description': 'The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 28 divided by the CRP Level at Week 0'}, {'measure': 'Ratio of C-Reactive Protein (CRP) Level at Week 32 to CRP Level at Week 0', 'timeFrame': "Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.", 'description': 'The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 32 divided by the CRP Level at Week 0'}, {'measure': 'Ratio of C-Reactive Protein (CRP) Level at Week 34 to CRP Level at Week 0', 'timeFrame': "Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': 'The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 34 divided by the CRP Level at Week 0'}, {'measure': 'Ratio of C-Reactive Protein (CRP) Level at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) to CRP Level at Week 0', 'timeFrame': "Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': 'The ratio is calculated as the C-Reactive Protein (CRP) Level at Last Visit (Week 34 for completers or the Withdrawal Visit for premature withdrawals)divided by the CRP Level at Week 0'}, {'measure': "Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 8", 'timeFrame': "Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.", 'description': "70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': "Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 10", 'timeFrame': "Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.", 'description': "70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': "Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 12", 'timeFrame': "Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.", 'description': "70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': "Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 14", 'timeFrame': "Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.", 'description': "70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': "Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 16", 'timeFrame': "Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.", 'description': "70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': "Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 20", 'timeFrame': "Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.", 'description': "70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': "Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 24", 'timeFrame': "Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.", 'description': "70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': "Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 28", 'timeFrame': "Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.", 'description': "70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': "Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 32", 'timeFrame': "Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.", 'description': "70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': "Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 34", 'timeFrame': "Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': "70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': "Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)", 'timeFrame': "Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.", 'description': "70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Crohn's Disease", 'CDP870', 'Certolizumab pegol', 'CZP'], 'conditions': ["Crohn's Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': "This 26-week extension study evaluates the efficacy and safety of certolizumab pegol administered subcutaneously every 4 weeks (dosed at Weeks 16, 20, 24, 28 and 32) in subjects with active Crohn's disease who had no clinical response at Week 6 to induction therapy in the 6-week double-blind main study, C87037 (NCT00291668), but subsequently showed clinical response at Week 14 to repeated induction therapy (dosed at Weeks 8, 10 and 12) in this extension study.", 'detailedDescription': "This study is an open-label extension study which follows on from the 6-week double-blind main study C87037 (NCT00291668). All 'Week' numbers quoted are relative to the start of the double-blind main study. The first visit in this extension study is at Week 8, and the final efficacy assessment in this extension study, 26 weeks later, is at Week 34."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '64 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects who gave written informed consent and who did not show clinical efficacy at Week 6 of the double-blind main study (NCT00291668) \\[reduction in Crohn's Disease Activity Index (CDAI) score of ≥100 points from Week 0, or remission (CDAI ≤150)\\]\n\nExclusion Criteria:\n\n* Subjects who experienced aggravation of Crohn's Disease during the double-blind main study (NCT00291668) and required treatment change"}, 'identificationModule': {'nctId': 'NCT00329420', 'briefTitle': 'Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (NCT00291668)', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': "A Multi-center, Open-label Study to Investigate the Efficacy and Safety of CDP870 in Active Crohn's Disease Patients, Who Showed no Clinical Efficacy in a Remission Induction Study (Study C87037) But Showed Clinical Efficacy After Additional Remission Induction Therapy Was Applied, at Week 26 After Subcutaneous Administration of CDP870 400 mg From Week 8 Until Week 24 at 4-week Intervals", 'orgStudyIdInfo': {'id': 'C87048'}, 'secondaryIdInfos': [{'id': '2014-004400-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg in this extension study / Placebo in double-blind main study (NCT00291668)', 'interventionNames': ['Biological: Certolizumab pegol']}, {'type': 'EXPERIMENTAL', 'label': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg in this extension study / Certolizumab pegol (CZP) 200 mg in double-blind main study (NCT00291668)', 'interventionNames': ['Biological: Certolizumab pegol']}, {'type': 'EXPERIMENTAL', 'label': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg in this extension study / Certolizumab pegol (CZP) 400 mg in double-blind main study (NCT00291668)', 'interventionNames': ['Biological: Certolizumab pegol']}], 'interventions': [{'name': 'Certolizumab pegol', 'type': 'BIOLOGICAL', 'otherNames': ['CDP870', 'Cimzia', 'CZP'], 'description': 'Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Placebo at Weeks 0, 2 and 4.', 'armGroupLabels': ['CZP 400 mg / Placebo']}, {'name': 'Certolizumab pegol', 'type': 'BIOLOGICAL', 'otherNames': ['CDP870', 'Cimzia', 'CZP'], 'description': 'Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Certolizumab pegol (CZP) 200 mg at Weeks 0, 2 and 4.', 'armGroupLabels': ['CZP 400 mg / CZP 200 mg']}, {'name': 'Certolizumab pegol', 'type': 'BIOLOGICAL', 'otherNames': ['CDP870', 'Cimzia', 'CZP'], 'description': 'Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Certolizumab pegol (CZP) 400 mg at Weeks 0, 2 and 4.', 'armGroupLabels': ['CZP 400 mg / CZP 400 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aichi-Gun', 'state': 'Aichi-ken', 'country': 'Japan'}, {'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Toyoake', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.038, 'lon': 136.99931}}, {'city': 'Toyohashi', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.76667, 'lon': 137.38333}}, {'city': 'Kashiwa', 'state': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.86224, 'lon': 139.97732}}, {'city': 'Sakura', 'state': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.71667, 'lon': 140.23333}}, {'city': 'Chikusino', 'state': 'Fukuoka', 'country': 'Japan'}, {'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Asahikawa', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.77063, 'lon': 142.36489}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Nishinomiya', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.71562, 'lon': 135.33199}}, {'city': 'Kagoshima', 'state': 'Kagoshima-ken', 'country': 'Japan', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Miyazaki-gun', 'state': 'Miyazaki', 'country': 'Japan'}, {'city': 'Nagasaki', 'state': 'Nagasaki', 'country': 'Japan', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'city': 'Niigata', 'state': 'Niigata', 'country': 'Japan', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'city': 'Kurashiki', 'state': 'Okayama-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.58333, 'lon': 133.76667}}, {'city': 'Tyuto-gun', 'state': 'Okianawa', 'country': 'Japan'}, {'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka Suita', 'state': 'Osaka', 'country': 'Japan'}, {'city': 'Shiga Otsu', 'state': 'Shiga', 'country': 'Japan'}, {'city': 'Shinjyuku/Tokyo', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Shinjyuku', 'state': 'Tokyo', 'country': 'Japan'}], 'overallOfficials': [{'name': 'UCB Clinical Trial Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': '+1 877 822 9493 (UCB)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}