Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-02-25 @ 9:49 PM
Study NCT ID:
NCT00329550
Status:
COMPLETED
Last Update Posted:
2015-03-18
First Post:
2006-05-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Maintenance Study of Certolizumab Pegol (CZP) in Crohn's Disease
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 30 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 36 weeks).", 'eventGroups': [{'id': 'EG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)', 'otherNumAtRisk': 9, 'otherNumAffected': 8, 'seriousNumAtRisk': 9, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'CZP 400 mg / CZP 200 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (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': 15, 'otherNumAffected': 12, 'seriousNumAtRisk': 15, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'CZP 400 mg / CZP 400 mg', 'description': 'Certolizumab pegol (CZP) 400 mg (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': 16, 'otherNumAffected': 15, 'seriousNumAtRisk': 16, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'Total 1 (This Extension Study Only)', 'description': 'This includes all adverse event data collected in this extension study for all 40 subjects who entered this extension study.', 'otherNumAtRisk': 40, 'otherNumAffected': 35, 'seriousNumAtRisk': 40, 'seriousNumAffected': 12}, {'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 (NCT00291668) and this extension study for all 40 subjects who entered this extension study, 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': 40, 'otherNumAffected': 35, 'seriousNumAtRisk': 40, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Alopecia areata', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Antinuclear antibody increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Antinuclear antibody positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Chalazion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Colitis pseudomembranous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'DNA antibody positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dermatitis psoriasiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Disgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Eczema asteatotic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Eczema nummular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Extrapyramidal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Glossitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 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If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.'}, {'type': 'SECONDARY', 'title': "Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '-126.7', 'spread': '100.9', 'groupId': 'OG000'}, {'value': '-124.9', 'spread': '76.7', 'groupId': 'OG001'}, {'value': '-141.8', 'spread': '62.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 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Data collected after receipt of rescue therapy have been set to missing in that study. \\[Week 8 is the start of Study C87047\\].'}, {'type': 'SECONDARY', 'title': "Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '-152.6', 'spread': '96.8', 'groupId': 'OG000'}, {'value': '-145.4', 'spread': '80.5', 'groupId': 'OG001'}, {'value': '-152.8', 'spread': '54.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 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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 Crohn's Disease Activity Index (CDAI) Score at Week 16", 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '-162.8', 'spread': '98.9', 'groupId': 'OG000'}, {'value': '-142.2', 'spread': '84.3', 'groupId': 'OG001'}, {'value': '-143.3', 'spread': '69.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 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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 Crohn's Disease Activity Index (CDAI) Score at Week 20", 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '-147.0', 'spread': '38.8', 'groupId': 'OG000'}, {'value': '-149.4', 'spread': '85.6', 'groupId': 'OG001'}, {'value': '-130.7', 'spread': '70.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 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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 Crohn's Disease Activity Index (CDAI) Score at Week 24", 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '-158.6', 'spread': '53.7', 'groupId': 'OG000'}, {'value': '-153.3', 'spread': '53.7', 'groupId': 'OG001'}, {'value': '-138.9', 'spread': '80.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 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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 Crohn's Disease Activity Index (CDAI) Score at Week 26", 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '-131.1', 'spread': '32.8', 'groupId': 'OG000'}, {'value': '-173.8', 'spread': '46.5', 'groupId': 'OG001'}, {'value': '-153.1', 'spread': '70.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 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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 Crohn's Disease Activity Index (CDAI) Score at Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals]", 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '-132.7', 'spread': '62.6', 'groupId': 'OG000'}, {'value': '-143.2', 'spread': '88.5', 'groupId': 'OG001'}, {'value': '-152.5', 'spread': '67.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 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If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.'}, {'type': 'SECONDARY', 'title': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '77.8', 'groupId': 'OG000'}, {'value': '60.0', 'groupId': 'OG001'}, {'value': '66.7', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of CDAI non-responders', 'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}, {'value': '33.3', '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': "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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.'}, {'type': 'SECONDARY', 'title': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '60.0', 'groupId': 'OG001'}, {'value': '60.0', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of CDAI non-responders', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}, {'value': '40.0', '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': "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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.'}, {'type': 'SECONDARY', 'title': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '44.4', 'groupId': 'OG000'}, {'value': '60.0', 'groupId': 'OG001'}, {'value': '53.3', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of CDAI non-responders', 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}, {'value': '46.7', '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': "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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.'}, {'type': 'SECONDARY', 'title': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals]", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '44.4', 'groupId': 'OG000'}, {'value': '73.3', 'groupId': 'OG001'}, {'value': '60.0', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of CDAI non-responders', 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000'}, {'value': '26.7', 'groupId': 'OG001'}, {'value': '40.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.", 'description': "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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving Remission at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '40.0', 'groupId': 'OG001'}, {'value': '53.3', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of subjects not in remission', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '60.0', 'groupId': 'OG001'}, {'value': '46.7', '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': "The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. 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': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '44.4', 'groupId': 'OG000'}, {'value': '46.7', 'groupId': 'OG001'}, {'value': '53.3', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of subjects not in remission', 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000'}, {'value': '53.3', 'groupId': 'OG001'}, {'value': '46.7', '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': "The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. 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': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '44.4', 'groupId': 'OG000'}, {'value': '46.7', 'groupId': 'OG001'}, {'value': '40.0', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of subjects not in remission', 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000'}, {'value': '53.3', 'groupId': 'OG001'}, {'value': '60.0', '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': "The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. 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': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '22.2', 'groupId': 'OG000'}, {'value': '53.3', 'groupId': 'OG001'}, {'value': '40.0', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of subjects not in remission', 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000'}, {'value': '46.7', 'groupId': 'OG001'}, {'value': '60.0', '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': "The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. 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': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '22.2', 'groupId': 'OG000'}, {'value': '46.7', 'groupId': 'OG001'}, {'value': '40.0', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of subjects not in remission', 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000'}, {'value': '53.3', 'groupId': 'OG001'}, {'value': '60.0', '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': "The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. 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 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '22.2', 'groupId': 'OG000'}, {'value': '46.7', 'groupId': 'OG001'}, {'value': '46.7', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of subjects not in remission', 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000'}, {'value': '53.3', 'groupId': 'OG001'}, {'value': '53.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.", 'description': "The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. 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 26 for Completers or the Withdrawal Visit for Premature Withdrawals)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '22.2', 'groupId': 'OG000'}, {'value': '46.7', 'groupId': 'OG001'}, {'value': '46.7', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of subjects not in remission', 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000'}, {'value': '53.3', 'groupId': 'OG001'}, {'value': '53.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.", 'description': "The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. 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 (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 (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 (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 6 to Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 6' is the last visit in the double-blind main study and 'Week 26' is 18 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 6 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': 'Responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study C87047 (NCT00329550). As so few subjects experienced disease progression in this study it was not possible to calculate the median time to disease progression. Please see post-hoc outcome measure 80 where the number of subjects with disease progression is presented.'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '33.8', 'spread': '25.6', 'groupId': 'OG000'}, {'value': '30.4', 'spread': '25.8', 'groupId': 'OG001'}, {'value': '23.7', 'spread': '20.3', '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 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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. \\[Week 8 is the start of Study C87047\\].'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '37.6', 'spread': '27.0', 'groupId': 'OG000'}, {'value': '29.9', 'spread': '28.6', 'groupId': 'OG001'}, {'value': '25.5', 'spread': '20.3', '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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '31.0', 'spread': '31.6', 'groupId': 'OG000'}, {'value': '30.1', 'spread': '25.4', 'groupId': 'OG001'}, {'value': '22.6', 'spread': '22.4', '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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '32.2', 'spread': '20.7', 'groupId': 'OG000'}, {'value': '31.6', 'spread': '27.6', 'groupId': 'OG001'}, {'value': '19.2', 'spread': '25.9', '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 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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '34.0', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '32.7', 'spread': '24.6', 'groupId': 'OG001'}, {'value': '23.6', 'spread': '22.5', '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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '33.4', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '38.4', 'spread': '27.0', 'groupId': 'OG001'}, {'value': '28.2', 'spread': '19.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '28.0', 'spread': '21.5', 'groupId': 'OG000'}, {'value': '33.3', 'spread': '27.7', 'groupId': 'OG001'}, {'value': '26.1', 'spread': '20.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '10.7', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '8.6', 'groupId': 'OG001'}, {'value': '9.5', 'spread': '10.2', '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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. \\[Week 8 is the start of Study C87047\\].'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '12.6', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '10.8', 'groupId': 'OG001'}, {'value': '9.8', 'spread': '8.5', '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 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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '9.9', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '9.6', 'groupId': 'OG001'}, {'value': '6.7', '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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '9.5', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '11.3', 'spread': '9.7', 'groupId': 'OG001'}, {'value': '6.7', 'spread': '8.8', '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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '11.0', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '10.4', 'spread': '8.7', 'groupId': 'OG001'}, {'value': '8.0', 'spread': '9.5', '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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '11.6', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '10.4', 'groupId': 'OG001'}, {'value': '8.8', 'spread': '9.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 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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 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '9.6', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '10.1', 'groupId': 'OG001'}, {'value': '8.1', 'spread': '9.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 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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 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '7.6', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '5.9', 'groupId': 'OG001'}, {'value': '5.7', 'spread': '4.7', '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 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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. \\[Week 8 is the start of Study C87047\\].'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '7.4', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '6.0', 'groupId': 'OG001'}, {'value': '5.9', 'spread': '5.4', '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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '6.8', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '5.9', 'groupId': 'OG001'}, {'value': '5.9', 'spread': '6.5', '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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '7.5', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '6.6', 'groupId': 'OG001'}, {'value': '4.9', 'spread': '6.2', '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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '8.2', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '6.7', 'groupId': 'OG001'}, {'value': '6.2', 'spread': '3.5', '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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '6.4', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '5.6', 'groupId': 'OG001'}, {'value': '7.2', 'spread': '3.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '5.1', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '5.1', 'groupId': 'OG001'}, {'value': '7.2', 'spread': '3.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '9.4', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '8.6', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '8.7', '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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. \\[Week 8 is the start of Study C87047\\].'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '10.8', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '8.2', 'groupId': 'OG001'}, {'value': '5.4', 'spread': '9.6', '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 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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '8.0', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '8.4', 'groupId': 'OG001'}, {'value': '6.1', 'spread': '9.6', '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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '8.5', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '9.4', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '10.3', '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 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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '6.1', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '9.1', 'groupId': 'OG001'}, {'value': '6.2', 'spread': '10.3', '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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '9.4', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '11.3', 'spread': '11.1', 'groupId': 'OG001'}, {'value': '6.8', 'spread': '8.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '7.4', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '11.6', 'groupId': 'OG001'}, {'value': '5.8', 'spread': '9.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '6.1', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '7.1', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '4.0', '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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. \\[Week 8 is the start of Study C87047\\].'}, {'type': 'SECONDARY', 'title': 'Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '7.9', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '8.9', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '4.1', '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 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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '6.4', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '7.3', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '4.2', '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 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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '6.7', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '7.9', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '5.9', '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 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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '6.5', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '7.8', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '4.3', '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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '6.0', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '7.8', 'groupId': 'OG001'}, {'value': '5.7', 'spread': '5.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '6.0', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '8.5', 'groupId': 'OG001'}, {'value': '5.2', 'spread': '5.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 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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': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '21.37', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '68.0'}, {'value': '26.31', 'groupId': 'OG001', 'lowerLimit': '11.0', 'upperLimit': '77.0'}, {'value': '25.88', 'groupId': 'OG002', 'lowerLimit': '5.0', 'upperLimit': '92.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Week 0 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 0' is the Baseline visit in the double-blind main study.", 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '23.80', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '67.0'}, {'value': '19.11', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '115.0'}, {'value': '11.61', 'groupId': 'OG002', 'lowerLimit': '5.0', 'upperLimit': '67.0'}]}]}], '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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy have been set to missing in that study. \\[Week 8 is the start of Study C87047\\].'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein (CRP) Level at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '12.55', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '38.0'}, {'value': '14.91', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '100.0'}, {'value': '11.64', 'groupId': 'OG002', 'lowerLimit': '4.0', 'upperLimit': '56.0'}]}]}], '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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '16.12', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '58.0'}, {'value': '16.06', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '99.0'}, {'value': '14.05', 'groupId': 'OG002', 'lowerLimit': '5.0', 'upperLimit': '76.0'}]}]}], '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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '17.16', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '47.0'}, {'value': '13.16', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '73.0'}, {'value': '17.44', 'groupId': 'OG002', 'lowerLimit': '4.0', 'upperLimit': '63.0'}]}]}], '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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '10.97', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '40.0'}, {'value': '12.44', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '77.0'}, {'value': '16.84', 'groupId': 'OG002', 'lowerLimit': '5.0', 'upperLimit': '87.0'}]}]}], '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': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '15.94', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '48.0'}, {'value': '9.96', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '43.0'}, {'value': '13.11', 'groupId': 'OG002', 'lowerLimit': '4.0', 'upperLimit': '78.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.", 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 26 for Completers or the Withdrawal Visit for Premature Withdrawals)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '19.81', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '48.0'}, {'value': '13.12', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '81.0'}, {'value': '14.04', 'groupId': 'OG002', 'lowerLimit': '4.0', 'upperLimit': '78.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.", 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. 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If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.'}, {'type': 'SECONDARY', 'title': "Percentage of Subjects at Week 20 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '60.0', 'groupId': 'OG001'}, {'value': '73.3', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of 70-point non-responders', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}, {'value': '26.7', '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': "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': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.'}, {'type': 'SECONDARY', 'title': "Percentage of Subjects at Week 24 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '55.6', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}, {'value': '60.0', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of 70-point non-responders', 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '40.0', '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': "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': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.'}, {'type': 'SECONDARY', 'title': "Percentage of Subjects at Week 26 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '55.6', 'groupId': 'OG000'}, {'value': '73.3', 'groupId': 'OG001'}, {'value': '73.3', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of 70-point non-responders', 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000'}, {'value': '26.7', 'groupId': 'OG001'}, {'value': '26.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.", 'description': "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': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.'}, {'type': 'SECONDARY', 'title': "Percentage of Subjects at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '55.6', 'groupId': 'OG000'}, {'value': '73.3', 'groupId': 'OG001'}, {'value': '73.3', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of 70-point non-responders', 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000'}, {'value': '26.7', 'groupId': 'OG001'}, {'value': '26.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.", 'description': "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': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.'}, {'type': 'POST_HOC', 'title': 'Number of Subjects With Disease Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Week 6 to Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 6' is the last visit in the double-blind main study and 'Week 26' is 18 weeks after the first visit in this extension study.", 'description': "Disease progression is defined as:\n\n* an increase from Week 6 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': 'Responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study, C87047 (NCT00329550). As it was not possible to calculate the time to disease progression (outcome measure 22) 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 (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 (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 (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': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'comment': '1 subject in Safety Set is not in Full Analysis Set due to Good Clinical Practice non-compliance.', 'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Due to Relocation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment into this extension study was between March 2006 and April 2008. Of the 26 hospitals and medical centers throughout Japan in the main study, 16 sites went on to enter subjects in this extension study.', 'preAssignmentDetails': 'To enter this single-group extension study, C87047 (NCT00329550), subjects had to have responded at Week 6 of the double-blind main study, C87037 (NCT00291668). Recruitment details are provided for the 40 subjects who entered this extension study by the three possible treatment sequences received across both studies.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'CZP 400 mg / Placebo', 'description': 'Certolizumab pegol (CZP) 400 mg (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 (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 (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': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6.0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '34.0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0.0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.7', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '29.3', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '33.3', 'spread': '10.0', 'groupId': 'BG002'}, {'value': '31.7', 'spread': '9.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9.0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '31.0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '40.0', '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': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-27', 'studyFirstSubmitDate': '2006-05-22', 'resultsFirstSubmitDate': '2009-04-07', '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': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 26", 'timeFrame': "Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.", 'description': "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': "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': "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': "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': "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': "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 26", 'timeFrame': "Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.", 'description': "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 26 for Completers or the Withdrawal Visit for Premature Withdrawals]", 'timeFrame': "Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.", 'description': "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': "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': "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': "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': "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': "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 26 for Completers or the Withdrawal Visit for Premature Withdrawals]", 'timeFrame': "Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.", 'description': "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': "The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI 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': "The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI 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': "The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI 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': "The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI 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': "The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': 'Percentage of Subjects Achieving Remission at Week 26', 'timeFrame': "Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.", 'description': "The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI 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 26 for Completers or the Withdrawal Visit for Premature Withdrawals)', 'timeFrame': "Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.", 'description': "The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease."}, {'measure': 'Time to Disease Progression', 'timeFrame': "Week 6 to Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 6' is the last visit in the double-blind main study and 'Week 26' is 18 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 6 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 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score', '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 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score', '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 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score', '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 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score', '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 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score', '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 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score', 'timeFrame': "Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 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 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score', 'timeFrame': "Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 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 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score', '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 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score', '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 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score', '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 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score', '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 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score', '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 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score', 'timeFrame': "Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 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 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score', 'timeFrame': "Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 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 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score', '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 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score', '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 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score', '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 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score', '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 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score', '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 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score', 'timeFrame': "Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 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 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score', 'timeFrame': "Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 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 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score', '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 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score', '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 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score', '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 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score', '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 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score', '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 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score', 'timeFrame': "Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 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 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score', 'timeFrame': "Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 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 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score', '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 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score', '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 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score', '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 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score', '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 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score', '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 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score', 'timeFrame': "Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 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 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score', 'timeFrame': "Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 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 (NCT00291668)). '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 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 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 26', 'timeFrame': "Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study."}, {'measure': 'C-Reactive Protein (CRP) Level at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals)', 'timeFrame': "Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study."}, {'measure': 'Ratio of C-Reactive Protein (CRP) Level at Week 8 to 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."}, {'measure': 'Ratio of C-Reactive Protein (CRP) Level at Week 12 to 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."}, {'measure': 'Ratio of C-Reactive Protein (CRP) Level at Week 16 to 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."}, {'measure': 'Ratio of C-Reactive Protein (CRP) Level at Week 20 to 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."}, {'measure': 'Ratio of C-Reactive Protein (CRP) Level at Week 24 to 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."}, {'measure': 'Ratio of C-Reactive Protein (CRP) Level at Week 26 to Week 0', 'timeFrame': "Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study."}, {'measure': 'Ratio of C-Reactive Protein (CRP) Level at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) to Week 0', 'timeFrame': "Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study."}, {'measure': "Percentage of Subjects at Week 8 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From 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': "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 Subjects at Week 12 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From 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': "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 Subjects at Week 16 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From 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': "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 Subjects at Week 20 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From 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': "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 Subjects at Week 24 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From 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': "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 Subjects at Week 26 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0", 'timeFrame': "Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.", 'description': "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 Subjects at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0", 'timeFrame': "Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.", 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Certolizumab pegol', 'Cimzia', '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 is a multi-centre, open-label extension study in subjects who showed clinical response to induction therapy in the treatment of subjects with active Crohn's disease in the double-blind main study C87037 (NCT00291668).", 'detailedDescription': 'In the double-blind main study subjects were dosed at Weeks 0, 2 and 4, with the primary outcome, clinical response, being assessed at Week 6. Subjects who showed clinical response at Week 6 were eligible to enter this open-label extension study. The first visit in this extension study was 2 weeks after Week 6, i.e., Week 8. Subjects in this extension study were dosed at Weeks 8, 12, 16, 20 and 24, with the primary outcome, clinical response, being assessed at Week 26. All week numbers quoted are relative to the start of the double-blind main study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '64 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects who participated in main double-blind induction study C87037 (NCT00291668) and showed clinical efficacy\n\nExclusion Criteria:\n\n* Subjects who experienced aggravation of Crohn's disease during main double-blind induction study C87037 (NCT00291668) and required treatment change"}, 'identificationModule': {'nctId': 'NCT00329550', 'briefTitle': "Maintenance Study of Certolizumab Pegol (CZP) in Crohn's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': "A 26-week, Multi-center, Open-label Study to Investigate the Efficacy and Safety of CDP870 in Active Crohn's Disease Patients, Who Showed Clinical Efficacy in a Remission Induction Study (Study C87037 [NCT00291668]), at Week 26 After Subcutaneous Administration of CDP870 400 mg From Week 8 Until Week 24 at 4-week Intervals", 'orgStudyIdInfo': {'id': 'C87047'}, 'secondaryIdInfos': [{'id': '2014-004354-34', '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 (CZP)']}, {'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 (CZP)']}, {'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 (CZP)']}], 'interventions': [{'name': 'Certolizumab pegol (CZP)', 'type': 'BIOLOGICAL', 'otherNames': ['CDP870', 'Cimzia', 'CZP'], 'description': 'Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 12, 16, 20 and 24 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 (CZP)', 'type': 'BIOLOGICAL', 'otherNames': ['CDP870', 'Cimzia', 'CZP'], 'description': 'Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 12, 16, 20 and 24 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 (CZP)', 'type': 'BIOLOGICAL', 'otherNames': ['CDP870', 'Cimzia', 'CZP'], 'description': 'Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 12, 16, 20 and 24 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received certolizumab pegol 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': 'Okinawa', 'country': 'Japan'}, {'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'city': 'Ōtsu', 'state': 'Shiga', 'country': 'Japan', 'geoPoint': {'lat': 35.0, 'lon': 135.86667}}, {'city': 'Shinjyuku/Tokyo', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Shinjyuku', 'state': 'Tokyo', 'country': 'Japan'}], 'overallOfficials': [{'name': 'UCB Clinical Trial Call Center', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '+1 877 822 9493 (UCB)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Japan Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}