Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-02-25 @ 6:34 PM
Study NCT ID:
NCT00291668
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2006-02-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Study of CDP870/Certolizumab Pegol in Patients With Active 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': {'email': 'UCBCares@ucb.com', 'phone': '+1844 599', 'title': 'UCB', 'phoneExt': '2273', 'organization': 'Cares'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected from the time of signing the informed consent through the last Observation (up to 28 weeks).', 'description': 'Adverse Events refer to the Safety Population, including all randomized subjects who received at least one dose of study medication (Placebo or Certolizumab Pegol).', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 16, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Certolizumab Pegol 200 mg', 'description': 'Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 11, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Certolizumab Pegol 400 mg', 'description': 'Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 14, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Pharynx discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Comedone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}], 'seriousEvents': [{'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Crohn's Disease Activity Index (CDAI) Response (Clinical Response or Remission) at Week 6", 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '40.0'}, {'value': '43.3', 'groupId': 'OG001', 'lowerLimit': '25.6', 'upperLimit': '61.1'}, {'value': '48.4', 'groupId': 'OG002', 'lowerLimit': '30.8', 'upperLimit': '66.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 6', 'description': 'CDAI Response is presented as the percentage of subjects with clinical response at Week 6 or remission at Week 6. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 6) - (CDAI score at Week 0). Remission is defined as a CDAI of \\<= 150 at Week 6.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}, {'type': 'SECONDARY', 'title': "Crohn's Disease Activity Index (CDAI) Score at Week 2", 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'categories': [{'measurements': [{'value': '255.9', 'spread': '68.02', 'groupId': 'OG000'}, {'value': '214.2', 'spread': '83.51', 'groupId': 'OG001'}, {'value': '224.9', 'spread': '85.05', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2', 'description': "The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}, {'type': 'SECONDARY', 'title': "Crohn's Disease Activity Index (CDAI) Score at Week 4", 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'categories': [{'measurements': [{'value': '243.1', 'spread': '68.57', 'groupId': 'OG000'}, {'value': '199.7', 'spread': '91.25', 'groupId': 'OG001'}, {'value': '204.6', 'spread': '75.10', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': "The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}, {'type': 'SECONDARY', 'title': "Crohn's Disease Activity Index (CDAI) Score at Week 6", 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'categories': [{'measurements': [{'value': '232.4', 'spread': '89.28', 'groupId': 'OG000'}, {'value': '211.0', 'spread': '99.91', 'groupId': 'OG001'}, {'value': '198.1', 'spread': '87.88', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 6', 'description': "The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Achieve CDAI Response at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '28.2'}, {'value': '40.0', 'groupId': 'OG001', 'lowerLimit': '22.5', 'upperLimit': '57.5'}, {'value': '32.3', 'groupId': 'OG002', 'lowerLimit': '15.8', 'upperLimit': '48.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2', 'description': 'CDAI Response at Week 2 is defined as clinical response at Week 2 or remission at Week 2. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 2) - (CDAI score at Week 0). Remission is defined as a CDAI score of \\<= 150 points.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Achieve CDAI Response at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000', 'lowerLimit': '7.6', 'upperLimit': '36.2'}, {'value': '46.7', 'groupId': 'OG001', 'lowerLimit': '28.8', 'upperLimit': '64.5'}, {'value': '38.7', 'groupId': 'OG002', 'lowerLimit': '21.6', 'upperLimit': '55.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 4', 'description': 'CDAI Response at Week 4 is defined as clinical response at Week 4 or remission at Week 4. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 4) - (CDAI score at Week 0). Remission is defined as a CDAI score of \\<= 150 points.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'categories': [{'measurements': [{'value': '28.1', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': '43.7'}, {'value': '46.7', 'groupId': 'OG001', 'lowerLimit': '28.8', 'upperLimit': '64.5'}, {'value': '45.2', 'groupId': 'OG002', 'lowerLimit': '27.6', 'upperLimit': '62.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2', 'description': "The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease 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', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '40.0'}, {'value': '56.7', 'groupId': 'OG001', 'lowerLimit': '38.9', 'upperLimit': '74.4'}, {'value': '54.8', 'groupId': 'OG002', 'lowerLimit': '37.3', 'upperLimit': '72.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 4', 'description': "The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease 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', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'categories': [{'measurements': [{'value': '43.8', 'groupId': 'OG000', 'lowerLimit': '26.6', 'upperLimit': '60.9'}, {'value': '53.3', 'groupId': 'OG001', 'lowerLimit': '35.5', 'upperLimit': '71.2'}, {'value': '61.3', 'groupId': 'OG002', 'lowerLimit': '44.1', 'upperLimit': '78.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 6', 'description': "The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease 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', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '9.2'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '34.3'}, {'value': '16.1', 'groupId': 'OG002', 'lowerLimit': '3.2', 'upperLimit': '29.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2', 'description': 'Remission at Week 2 is defined as a CDAI score \\<= 150 points at Week 2.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '14.6'}, {'value': '26.7', 'groupId': 'OG001', 'lowerLimit': '10.8', 'upperLimit': '42.5'}, {'value': '22.6', 'groupId': 'OG002', 'lowerLimit': '7.9', 'upperLimit': '37.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'Remission at Week 4 is defined as a CDAI score \\<= 150 points at Week 4.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '28.2'}, {'value': '26.7', 'groupId': 'OG001', 'lowerLimit': '10.8', 'upperLimit': '42.5'}, {'value': '32.3', 'groupId': 'OG002', 'lowerLimit': '15.8', 'upperLimit': '48.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'description': 'Remission at Week 6 is defined as a CDAI score \\<= 150 points at Week 6.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '28.2'}, {'value': '36.7', 'groupId': 'OG001', 'lowerLimit': '19.4', 'upperLimit': '53.9'}, {'value': '29.0', 'groupId': 'OG002', 'lowerLimit': '13.1', 'upperLimit': '45.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2', 'description': 'Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 2) - (CDAI score at Week 0).', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '32.3'}, {'value': '36.7', 'groupId': 'OG001', 'lowerLimit': '19.4', 'upperLimit': '53.9'}, {'value': '32.3', 'groupId': 'OG002', 'lowerLimit': '15.8', 'upperLimit': '48.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 4', 'description': 'Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 4) - (CDAI score at Week 0).', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000', 'lowerLimit': '7.6', 'upperLimit': '36.2'}, {'value': '36.7', 'groupId': 'OG001', 'lowerLimit': '19.4', 'upperLimit': '53.9'}, {'value': '41.9', 'groupId': 'OG002', 'lowerLimit': '24.6', 'upperLimit': '59.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 6', 'description': 'Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 6) - (CDAI score at Week 0).', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}, {'type': 'SECONDARY', 'title': 'Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'categories': [{'measurements': [{'value': '171.3', 'spread': '22.45', 'groupId': 'OG000'}, {'value': '166.1', 'spread': '22.14', 'groupId': 'OG001'}, {'value': '169.7', 'spread': '23.24', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2', 'description': 'The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}, {'type': 'SECONDARY', 'title': 'Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'categories': [{'measurements': [{'value': '172.6', 'spread': '24.04', 'groupId': 'OG000'}, {'value': '169.4', 'spread': '21.75', 'groupId': 'OG001'}, {'value': '170.3', 'spread': '23.72', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}, {'type': 'SECONDARY', 'title': 'Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'categories': [{'measurements': [{'value': '173.1', 'spread': '25.49', 'groupId': 'OG000'}, {'value': '165.6', 'spread': '23.25', 'groupId': 'OG001'}, {'value': '170.8', 'spread': '24.54', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 6', 'description': 'The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}, {'type': 'SECONDARY', 'title': 'Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'title': 'Bowel Symptoms Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '54.4', 'spread': '7.17', 'groupId': 'OG000'}, {'value': '53.4', 'spread': '8.18', 'groupId': 'OG001'}, {'value': '54.7', 'spread': '8.77', 'groupId': 'OG002'}]}]}, {'title': 'Systemic Symptoms Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22.4', 'spread': '5.01', 'groupId': 'OG000'}, {'value': '22.4', 'spread': '5.17', 'groupId': 'OG001'}, {'value': '22.7', 'spread': '4.51', 'groupId': 'OG002'}]}]}, {'title': 'Emotional Function Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '65.3', 'spread': '8.91', 'groupId': 'OG000'}, {'value': '62.3', 'spread': '9.54', 'groupId': 'OG001'}, {'value': '63.3', 'spread': '8.53', 'groupId': 'OG002'}]}]}, {'title': 'Social Function Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.4', 'spread': '5.64', 'groupId': 'OG000'}, {'value': '28.0', 'spread': '4.33', 'groupId': 'OG001'}, {'value': '29.0', 'spread': '5.03', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2', 'description': 'The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life.\n\nThere are 4 IBDQ Domain Scores:\n\n* Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7)\n* Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )\n* Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7)\n* Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}, {'type': 'SECONDARY', 'title': 'Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'title': 'Bowel Symptoms Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '55.4', 'spread': '7.22', 'groupId': 'OG000'}, {'value': '54.0', 'spread': '9.00', 'groupId': 'OG001'}, {'value': '55.5', 'spread': '8.04', 'groupId': 'OG002'}]}]}, {'title': 'Systemic Symptoms Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.3', 'spread': '5.49', 'groupId': 'OG000'}, {'value': '23.4', 'spread': '4.21', 'groupId': 'OG001'}, {'value': '22.9', 'spread': '4.44', 'groupId': 'OG002'}]}]}, {'title': 'Emotional Function Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '65.3', 'spread': '8.85', 'groupId': 'OG000'}, {'value': '63.1', 'spread': '8.90', 'groupId': 'OG001'}, {'value': '63.2', 'spread': '9.55', 'groupId': 'OG002'}]}]}, {'title': 'Social Function Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28.8', 'spread': '6.73', 'groupId': 'OG000'}, {'value': '28.9', 'spread': '4.82', 'groupId': 'OG001'}, {'value': '28.7', 'spread': '5.62', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life.\n\nThere are 4 IBDQ Domain Scores:\n\n* Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7)\n* Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )\n* Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7)\n* Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}, {'type': 'SECONDARY', 'title': 'Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'title': 'Bowel Symptoms Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '55.4', 'spread': '7.77', 'groupId': 'OG000'}, {'value': '51.8', 'spread': '8.44', 'groupId': 'OG001'}, {'value': '55.8', 'spread': '8.43', 'groupId': 'OG002'}]}]}, {'title': 'Systemic Symptoms Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.3', 'spread': '6.74', 'groupId': 'OG000'}, {'value': '22.4', 'spread': '4.49', 'groupId': 'OG001'}, {'value': '23.4', 'spread': '4.62', 'groupId': 'OG002'}]}]}, {'title': 'Emotional Function Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '65.3', 'spread': '8.76', 'groupId': 'OG000'}, {'value': '63.2', 'spread': '9.45', 'groupId': 'OG001'}, {'value': '62.1', 'spread': '10.43', 'groupId': 'OG002'}]}]}, {'title': 'Social Function Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.2', 'spread': '6.48', 'groupId': 'OG000'}, {'value': '28.1', 'spread': '5.69', 'groupId': 'OG001'}, {'value': '29.5', 'spread': '5.09', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 6', 'description': 'The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life.\n\nThere are 4 IBDQ Domain Scores:\n\n* Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7)\n* Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )\n* Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7)\n* Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}, {'type': 'SECONDARY', 'title': 'Concentration of C-reactive Protein (CRP) Value at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'categories': [{'measurements': [{'value': '22.15', 'groupId': 'OG000', 'lowerLimit': '15.43', 'upperLimit': '31.80'}, {'value': '13.58', 'groupId': 'OG001', 'lowerLimit': '9.45', 'upperLimit': '19.52'}, {'value': '13.86', 'groupId': 'OG002', 'lowerLimit': '9.11', 'upperLimit': '21.09'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 2', 'description': 'CRP data for subjects receiving rescue medication were excluded.', 'unitOfMeasure': 'mg/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}, {'type': 'SECONDARY', 'title': 'Concentration of C-reactive Protein (CRP) Value at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'categories': [{'measurements': [{'value': '23.47', 'groupId': 'OG000', 'lowerLimit': '16.02', 'upperLimit': '34.40'}, {'value': '12.87', 'groupId': 'OG001', 'lowerLimit': '8.56', 'upperLimit': '19.36'}, {'value': '12.02', 'groupId': 'OG002', 'lowerLimit': '8.68', 'upperLimit': '16.65'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 4', 'description': 'CRP data for subjects receiving rescue medication were excluded.', 'unitOfMeasure': 'mg/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}, {'type': 'SECONDARY', 'title': 'Concentration of C-reactive Protein (CRP) Value at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'categories': [{'measurements': [{'value': '23.32', 'groupId': 'OG000', 'lowerLimit': '16.95', 'upperLimit': '32.07'}, {'value': '15.10', 'groupId': 'OG001', 'lowerLimit': '9.46', 'upperLimit': '24.11'}, {'value': '12.62', 'groupId': 'OG002', 'lowerLimit': '8.79', 'upperLimit': '18.11'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 6', 'description': 'CRP data for subjects receiving rescue medication were excluded.', 'unitOfMeasure': 'mg/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}, {'type': 'SECONDARY', 'title': 'C-reactive Protein (CRP) Ratio to Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'categories': [{'measurements': [{'value': '0.85', 'groupId': 'OG000', 'lowerLimit': '0.64', 'upperLimit': '1.13'}, {'value': '0.58', 'groupId': 'OG001', 'lowerLimit': '0.42', 'upperLimit': '0.80'}, {'value': '0.50', 'groupId': 'OG002', 'lowerLimit': '0.35', 'upperLimit': '0.72'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Week 2', 'description': 'CRP data for subjects receiving rescue medication were excluded.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}, {'type': 'SECONDARY', 'title': 'C-reactive Protein (CRP) Ratio to Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'categories': [{'measurements': [{'value': '1.04', 'groupId': 'OG000', 'lowerLimit': '0.83', 'upperLimit': '1.31'}, {'value': '0.53', 'groupId': 'OG001', 'lowerLimit': '0.37', 'upperLimit': '0.76'}, {'value': '0.44', 'groupId': 'OG002', 'lowerLimit': '0.32', 'upperLimit': '0.60'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'CRP data for subjects receiving rescue medication were excluded.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}, {'type': 'SECONDARY', 'title': 'C-reactive Protein (CRP) Ratio to Baseline at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Set (Placebo Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG001', 'title': 'Full Analysis Set (CZP 200 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}, {'id': 'OG002', 'title': 'Full Analysis Set (CZP 400 mg Treated Subjects)', 'description': "The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:\n\n* Subjects with Good Clinical Practice (GCP) violations\n* Subjects who were not diagnosed (definitely) with Crohn's Disease\n* Subjects who received no dose of study medication\n* Subjects with no data after randomization"}], 'classes': [{'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.85', 'upperLimit': '1.25'}, {'value': '0.63', 'groupId': 'OG001', 'lowerLimit': '0.40', 'upperLimit': '0.98'}, {'value': '0.46', 'groupId': 'OG002', 'lowerLimit': '0.32', 'upperLimit': '0.66'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'CRP data for subjects receiving rescue medication were excluded.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:\n\nSubjects\n\n* with Good Clinical Practice (GCP) violations\n* who were not diagnosed (definitely) with CD\n* who received no dose of study medication\n* with no data after randomization'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.'}, {'id': 'FG001', 'title': 'Certolizumab Pegol 200 mg', 'description': 'Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4.'}, {'id': 'FG002', 'title': 'Certolizumab Pegol 400 mg', 'description': 'Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'SAE, non-fatal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'AE, non-serious non-fatal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'SAE, non-fatal+AE, non-serious non-fatal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study started to enroll subjects in March 2006 and conluded in November 2007.', 'preAssignmentDetails': 'Participant Flow refers to the Safety Set, including all randomized subjects who received at least one dose of study medication (Placebo or Certolizumab Pegol).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.'}, {'id': 'BG001', 'title': 'Certolizumab Pegol 200 mg', 'description': 'Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4.'}, {'id': 'BG002', 'title': 'Certolizumab Pegol 400 mg', 'description': 'Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.'}, {'id': 'BG003', 'title': 'Total Title'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.6', 'spread': '8.16', 'groupId': 'BG000'}, {'value': '32.7', 'spread': '9.34', 'groupId': 'BG001'}, {'value': '31.4', 'spread': '8.27', 'groupId': 'BG002'}, {'value': '31.5', 'spread': '8.54', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline Characteristics refer to the Safety Population, including all randomized subjects who received at least one dose of study medication (Placebo or Certolizumab Pegol).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2007-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-14', 'studyFirstSubmitDate': '2006-02-10', 'resultsFirstSubmitDate': '2018-02-08', 'studyFirstSubmitQcDate': '2006-02-10', 'lastUpdatePostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-14', 'studyFirstPostDateStruct': {'date': '2006-02-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2007-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Crohn's Disease Activity Index (CDAI) Response (Clinical Response or Remission) at Week 6", 'timeFrame': 'Baseline, Week 6', 'description': 'CDAI Response is presented as the percentage of subjects with clinical response at Week 6 or remission at Week 6. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 6) - (CDAI score at Week 0). Remission is defined as a CDAI of \\<= 150 at Week 6.'}], 'secondaryOutcomes': [{'measure': "Crohn's Disease Activity Index (CDAI) Score at Week 2", 'timeFrame': 'Week 2', 'description': "The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity."}, {'measure': "Crohn's Disease Activity Index (CDAI) Score at Week 4", 'timeFrame': 'Week 4', 'description': "The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity."}, {'measure': "Crohn's Disease Activity Index (CDAI) Score at Week 6", 'timeFrame': 'Week 6', 'description': "The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as 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 Who Achieve CDAI Response at Week 2', 'timeFrame': 'Baseline, Week 2', 'description': 'CDAI Response at Week 2 is defined as clinical response at Week 2 or remission at Week 2. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 2) - (CDAI score at Week 0). Remission is defined as a CDAI score of \\<= 150 points.'}, {'measure': 'Percentage of Subjects Who Achieve CDAI Response at Week 4', 'timeFrame': 'Baseline, Week 4', 'description': 'CDAI Response at Week 4 is defined as clinical response at Week 4 or remission at Week 4. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 4) - (CDAI score at Week 0). Remission is defined as a CDAI score of \\<= 150 points.'}, {'measure': 'Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 2', 'timeFrame': 'Baseline, Week 2', 'description': "The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease 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 Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 4', 'timeFrame': 'Baseline, Week 4', 'description': "The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease 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 Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 6', 'timeFrame': 'Baseline, Week 6', 'description': "The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease 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 Who Achieve Remission (CDAI <= 150) at Week 2', 'timeFrame': 'Week 2', 'description': 'Remission at Week 2 is defined as a CDAI score \\<= 150 points at Week 2.'}, {'measure': 'Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 4', 'timeFrame': 'Week 4', 'description': 'Remission at Week 4 is defined as a CDAI score \\<= 150 points at Week 4.'}, {'measure': 'Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 6', 'timeFrame': 'Week 6', 'description': 'Remission at Week 6 is defined as a CDAI score \\<= 150 points at Week 6.'}, {'measure': 'Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 2', 'timeFrame': 'Baseline, Week 2', 'description': 'Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 2) - (CDAI score at Week 0).'}, {'measure': 'Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 4', 'timeFrame': 'Baseline, Week 4', 'description': 'Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 4) - (CDAI score at Week 0).'}, {'measure': 'Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 6', 'timeFrame': 'Baseline, Week 6', 'description': 'Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 6) - (CDAI score at Week 0).'}, {'measure': 'Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 2', 'timeFrame': 'Week 2', 'description': 'The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.'}, {'measure': 'Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 4', 'timeFrame': 'Week 4', 'description': 'The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.'}, {'measure': 'Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 6', 'timeFrame': 'Week 6', 'description': 'The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.'}, {'measure': 'Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 2', 'timeFrame': 'Week 2', 'description': 'The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life.\n\nThere are 4 IBDQ Domain Scores:\n\n* Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7)\n* Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )\n* Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7)\n* Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )'}, {'measure': 'Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 4', 'timeFrame': 'Week 4', 'description': 'The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life.\n\nThere are 4 IBDQ Domain Scores:\n\n* Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7)\n* Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )\n* Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7)\n* Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )'}, {'measure': 'Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 6', 'timeFrame': 'Week 6', 'description': 'The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life.\n\nThere are 4 IBDQ Domain Scores:\n\n* Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7)\n* Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )\n* Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7)\n* Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )'}, {'measure': 'Concentration of C-reactive Protein (CRP) Value at Week 2', 'timeFrame': 'Week 2', 'description': 'CRP data for subjects receiving rescue medication were excluded.'}, {'measure': 'Concentration of C-reactive Protein (CRP) Value at Week 4', 'timeFrame': 'Week 4', 'description': 'CRP data for subjects receiving rescue medication were excluded.'}, {'measure': 'Concentration of C-reactive Protein (CRP) Value at Week 6', 'timeFrame': 'Week 6', 'description': 'CRP data for subjects receiving rescue medication were excluded.'}, {'measure': 'C-reactive Protein (CRP) Ratio to Baseline at Week 2', 'timeFrame': 'Baseline, Week 2', 'description': 'CRP data for subjects receiving rescue medication were excluded.'}, {'measure': 'C-reactive Protein (CRP) Ratio to Baseline at Week 4', 'timeFrame': 'Baseline, Week 4', 'description': 'CRP data for subjects receiving rescue medication were excluded.'}, {'measure': 'C-reactive Protein (CRP) Ratio to Baseline at Week 6', 'timeFrame': 'Baseline, Week 6', 'description': 'CRP data for subjects receiving rescue medication were excluded.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Crohn's Disease", 'CDP870', 'Certolizumab pegol'], '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, randomized, double-blind, dose response clinical study of CDP870 in patients with Crohn's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nInclusion Criteria:\n\n* Patients who are diagnosed with Crohn's disease (according to the Crohn's disease diagnostic criteria developed by the research group on intractable inflammatory bowel disorders \\[Shimoyama group, January 25, 2002\\]) at least 24 weeks before the starting date of the observation period\n* Patients with Crohn's Disease Activity Index (CDAI) score ranging from 220 to 450 inclusive during the observation period\n* C-reactive protein (CRP) of 1 mg/dL or higher in the laboratory test performed at the start of the observation period\n\nExclusion Criteria:\n\n* Stoma patient\n* Patients with a history of severe hypersensitivity or anphylactic reaction to anti-TNF alpha antibody\n* Patients who participated in a clinical study with CDP870\n* Pregnant or lactating patients, patients of childbearing potential, or patients who will attempt pregnancy during the study period\n* Patients who are judged inappropriate for enrollment by the principal investigator or subinvestigators\n\nExclusion Criteria:"}, 'identificationModule': {'nctId': 'NCT00291668', 'briefTitle': "Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': "A Phase II, Multi-center, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study to Assess the Safety and Efficacy of CDP870/Certolizumab Pegol, Dosed Subcutaneously in Patients With Active Crohn's Disease", 'orgStudyIdInfo': {'id': 'C87037'}, 'secondaryIdInfos': [{'id': '2014-004399-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Certolizumab pegol 200 mg', 'description': 'Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4.', 'interventionNames': ['Biological: Certolizumab Pegol', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Certolizumab pegol 400 mg', 'description': 'Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.', 'interventionNames': ['Biological: Certolizumab Pegol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Certolizumab Pegol', 'type': 'BIOLOGICAL', 'otherNames': ['CDP870'], 'description': '* Active Substance: Certolizumab Pegol\n* Pharmaceutical Form: Solution for injection in pre-filled syringe\n* Concentration: 200 mg/mL\n* Route of Administration: Subcutaneous use', 'armGroupLabels': ['Certolizumab pegol 200 mg', 'Certolizumab pegol 400 mg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '* Active Substance: isotonic sodium chloride solution\n* Pharmaceutical Form: Solution for injection\n* Concentration: 1 mL\n* Route of Administration: Subcutaneous use', 'armGroupLabels': ['Certolizumab pegol 200 mg', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aichi-Gun', 'state': 'Aichi-ken', 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