Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-02-27 @ 4:06 PM
Study NCT ID:
NCT00552058
Status:
COMPLETED
Last Update Posted:
2018-08-09
First Post:
2007-10-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Spain']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068582', 'term': 'Certolizumab Pegol'}], 'ancestors': [{'id': 'D011092', 'term': 'Polyethylene Glycols'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D007140', 'term': 'Immunoglobulin Fab Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+1 877 822 9493', 'title': 'Study Director', 'organization': 'UCB'}, 'certainAgreement': {'otherDetails': 'UCB has \\> 60 days but \\<= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'up to 6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Certolizumab Pegol', 'description': 'Certolizumab pegol 400 mg for subcutaneous (sc) injection', 'otherNumAtRisk': 223, 'otherNumAffected': 48, 'seriousNumAtRisk': 223, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo, saline solution for sc injection', 'otherNumAtRisk': 215, 'otherNumAffected': 42, 'seriousNumAtRisk': 215, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}], 'seriousEvents': [{'term': 'SPLENOMEGALY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': "CROHN'S DISEASE", 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'INTESTINAL OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'LARGE INTESTINAL OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'PANCREATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'PROCTALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'SMALL INTESTINAL OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'CLOSTRIDIAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'GASTROENTERITIS VIRAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'HIV INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'PERIANAL ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'CONTUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'FISTULA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'METASTATIC NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'RENAL COLIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'BRONCHOSPASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects in Clinical Remission at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Certolizumab Pegol', 'description': 'Certolizumab pegol 400 mg for subcutaneous (sc) injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, saline solution for sc injection'}], 'classes': [{'categories': [{'measurements': [{'value': '31.6', 'groupId': 'OG000', 'lowerLimit': '25.4', 'upperLimit': '37.8'}, {'value': '25.4', 'groupId': 'OG001', 'lowerLimit': '19.5', 'upperLimit': '31.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'description': "The percentage of subjects in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.", 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving a Clinical Response at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Certolizumab Pegol', 'description': 'Certolizumab pegol 400 mg for subcutaneous (sc) injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, saline solution for sc injection'}], 'classes': [{'categories': [{'measurements': [{'value': '40.5', 'groupId': 'OG000', 'lowerLimit': '33.9', 'upperLimit': '47.0'}, {'value': '34.0', 'groupId': 'OG001', 'lowerLimit': '27.6', 'upperLimit': '40.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0, Week 6', 'description': "The percentage of subjects achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates clinical remission and a score above 450 points indicates extremely severe disease.", 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Certolizumab Pegol', 'description': 'Certolizumab pegol 400 mg for subcutaneous (sc) injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, saline solution for sc injection'}], 'classes': [{'categories': [{'measurements': [{'value': '36.7', 'groupId': 'OG000', 'lowerLimit': '30.3', 'upperLimit': '43.2'}, {'value': '28.7', 'groupId': 'OG001', 'lowerLimit': '22.6', 'upperLimit': '34.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'description': 'The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 6 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.'}, {'type': 'SECONDARY', 'title': "Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6", 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Certolizumab Pegol', 'description': 'Certolizumab pegol 400 mg for subcutaneous (sc) injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, saline solution for sc injection'}], 'classes': [{'categories': [{'measurements': [{'value': '-96.7', 'spread': '100.86', 'groupId': 'OG000'}, {'value': '-73.1', 'spread': '95.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 6', 'description': "The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 6. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 192 and 183 subjects respectively are included in this summary and have assessments at both Weeks 0 and 6. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.'}, {'type': 'SECONDARY', 'title': 'Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Certolizumab Pegol', 'description': 'Certolizumab pegol 400 mg for subcutaneous (sc) injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, saline solution for sc injection'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.3', 'spread': '4.00', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '3.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 6', 'description': 'The change in Harvey Bradshaw Index (HBI) score from Week 0 to Week 6. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (score 1 per item). The first three items are scored for the previous day. Lower scores indicated better well being.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 196 and 187 subjects respectively are included in this summary and have assessments at both Weeks 0 and 6. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects in Clinical Remission at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Certolizumab Pegol', 'description': 'Certolizumab pegol 400 mg for subcutaneous (sc) injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, saline solution for sc injection'}], 'classes': [{'categories': [{'measurements': [{'value': '23.3', 'groupId': 'OG000', 'lowerLimit': '17.6', 'upperLimit': '28.9'}, {'value': '15.8', 'groupId': 'OG001', 'lowerLimit': '10.8', 'upperLimit': '20.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2', 'description': "The percentage of subjects in clinical remission at Week 2 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.", 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects in Clinical Remission at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Certolizumab Pegol', 'description': 'Certolizumab pegol 400 mg for subcutaneous (sc) injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, saline solution for sc injection'}], 'classes': [{'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000', 'lowerLimit': '20.6', 'upperLimit': '32.4'}, {'value': '19.1', 'groupId': 'OG001', 'lowerLimit': '13.8', 'upperLimit': '24.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': "The percentage of subjects in clinical remission at Week 4 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.", 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving a Clinical Response at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Certolizumab Pegol', 'description': 'Certolizumab pegol 400 mg for subcutaneous (sc) injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, saline solution for sc injection'}], 'classes': [{'categories': [{'measurements': [{'value': '33.0', 'groupId': 'OG000', 'lowerLimit': '26.7', 'upperLimit': '39.3'}, {'value': '20.1', 'groupId': 'OG001', 'lowerLimit': '14.7', 'upperLimit': '25.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0, Week 2', 'description': "The percentage of subjects achieving a clinical response at Week 2 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.", 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving a Clinical Response at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Certolizumab Pegol', 'description': 'Certolizumab pegol 400 mg for subcutaneous (sc) injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, saline solution for sc injection'}], 'classes': [{'categories': [{'measurements': [{'value': '35.3', 'groupId': 'OG000', 'lowerLimit': '29.0', 'upperLimit': '41.7'}, {'value': '26.3', 'groupId': 'OG001', 'lowerLimit': '20.3', 'upperLimit': '32.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0, Week 4', 'description': "The percentage of subjects achieving a clinical response at Week 4 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.", 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.'}, {'type': 'SECONDARY', 'title': "Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2", 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Certolizumab Pegol', 'description': 'Certolizumab pegol 400 mg for subcutaneous (sc) injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, saline solution for sc injection'}], 'classes': [{'categories': [{'measurements': [{'value': '-72.6', 'spread': '81.26', 'groupId': 'OG000'}, {'value': '-41.8', 'spread': '82.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 2', 'description': "The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 2. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 204 and 198 subjects respectively are included in this summary and have assessments at both Weeks 0 and 2. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.'}, {'type': 'SECONDARY', 'title': "Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 4", 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Certolizumab Pegol', 'description': 'Certolizumab pegol 400 mg for subcutaneous (sc) injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, saline solution for sc injection'}], 'classes': [{'categories': [{'measurements': [{'value': '-88.8', 'spread': '91.36', 'groupId': 'OG000'}, {'value': '-65.7', 'spread': '83.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, Week 4', 'description': "The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 4. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 198 and 184 subjects respectively are included in this summary and have assessments at both Weeks 0 and 4. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Certolizumab Pegol', 'description': 'Certolizumab pegol 400 mg for subcutaneous (sc) injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, saline solution for sc injection'}], 'classes': [{'categories': [{'measurements': [{'value': '25.6', 'groupId': 'OG000', 'lowerLimit': '19.7', 'upperLimit': '31.4'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '13.0', 'upperLimit': '23.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2', 'description': 'The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 2 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Certolizumab Pegol', 'description': 'Certolizumab pegol 400 mg for subcutaneous (sc) injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, saline solution for sc injection'}], 'classes': [{'categories': [{'measurements': [{'value': '33.5', 'groupId': 'OG000', 'lowerLimit': '27.2', 'upperLimit': '39.8'}, {'value': '23.9', 'groupId': 'OG001', 'lowerLimit': '18.1', 'upperLimit': '29.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 4 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Certolizumab Pegol', 'description': 'Certolizumab pegol 400 mg for subcutaneous (sc) injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, saline solution for sc injection'}], 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'groupId': 'OG000', 'lowerLimit': '22.2', 'upperLimit': '38.5'}, {'value': '30.1', 'groupId': 'OG001', 'lowerLimit': '21.6', 'upperLimit': '38.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'description': "The percentage of subjects in the subgroup with less than 10 mg/L of C-reactive Protein (CRP) at Entry who are in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.", 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 122 and 113 subjects are in the less than 10 mg/L C-reactive Protein (CRP) subgroup at Entry, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Certolizumab Pegol', 'description': 'Certolizumab pegol 400 mg for subcutaneous (sc) injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, saline solution for sc injection'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '23.8', 'upperLimit': '42.9'}, {'value': '19.8', 'groupId': 'OG001', 'lowerLimit': '11.8', 'upperLimit': '27.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'description': "The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.", 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 93 and 96 subjects are in the 10 mg/L or greater C-reactive Protein (CRP) subgroup at Entry, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Certolizumab Pegol', 'description': 'Certolizumab pegol 400 mg for subcutaneous (sc) injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, saline solution for sc injection'}], 'classes': [{'categories': [{'measurements': [{'value': '37.7', 'groupId': 'OG000', 'lowerLimit': '29.1', 'upperLimit': '46.3'}, {'value': '35.4', 'groupId': 'OG001', 'lowerLimit': '26.6', 'upperLimit': '44.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0, Week 6', 'description': "The percentage of subjects in the subgroup with less than 10 mg/L C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.", 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 122 and 113 subjects are in the less than 10 mg/L C-reactive Protein (CRP) subgroup at Entry, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Certolizumab Pegol', 'description': 'Certolizumab pegol 400 mg for subcutaneous (sc) injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, saline solution for sc injection'}], 'classes': [{'categories': [{'measurements': [{'value': '44.1', 'groupId': 'OG000', 'lowerLimit': '34.0', 'upperLimit': '54.2'}, {'value': '32.3', 'groupId': 'OG001', 'lowerLimit': '22.9', 'upperLimit': '41.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0, Week 6', 'description': "The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.", 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 93 and 96 subjects are in the 10 mg/L or greater C-reactive Protein (CRP) subgroup at Entry, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Certolizumab Pegol', 'description': 'Certolizumab pegol 400 mg for subcutaneous (sc) injection'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo, saline solution for sc injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '223'}, {'groupId': 'FG001', 'numSubjects': '216'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '207'}, {'groupId': 'FG001', 'numSubjects': '192'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Other: Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other: Non Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other: Crossed Over to a Follow-up Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other: Low CDAI score, entry violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other: Positive Stool Result', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other: Randomized in error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other: Sponsors Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other: Early Roll Over', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants flow shows all subjects randomized. Safety analyses are based on actual treatment received; 1 subject randomized to placebo did not receive any treatment thus would be excluded due to the definition of the safety population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '438', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Certolizumab Pegol', 'description': 'Certolizumab pegol 400 mg for subcutaneous (sc) injection'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo, saline solution for sc injection'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '213', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '418', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.3', 'spread': '12.63', 'groupId': 'BG000'}, {'value': '38.8', 'spread': '12.76', 'groupId': 'BG001'}, {'value': '37.5', 'spread': '12.74', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}, {'title': 'Estonia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Latvia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 439}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'nctId': 'NCT03559660', 'statusForNctId': 'NO_LONGER_AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-10', 'studyFirstSubmitDate': '2007-10-18', 'resultsFirstSubmitDate': '2010-10-08', 'studyFirstSubmitQcDate': '2007-10-31', 'lastUpdatePostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-12-01', 'studyFirstPostDateStruct': {'date': '2007-11-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects in Clinical Remission at Week 6', 'timeFrame': 'Week 6', 'description': "The percentage of subjects in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease."}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects Achieving a Clinical Response at Week 6', 'timeFrame': 'Week 0, Week 6', 'description': "The percentage of subjects achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates clinical remission and a score above 450 points indicates extremely severe disease."}, {'measure': 'Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6', 'timeFrame': 'Week 6', 'description': 'The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 6 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.'}, {'measure': "Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6", 'timeFrame': 'Week 0 to Week 6', 'description': "The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 6. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease."}, {'measure': 'Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6', 'timeFrame': 'Week 0 to Week 6', 'description': 'The change in Harvey Bradshaw Index (HBI) score from Week 0 to Week 6. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (score 1 per item). The first three items are scored for the previous day. Lower scores indicated better well being.'}, {'measure': 'Percentage of Subjects in Clinical Remission at Week 2', 'timeFrame': 'Week 2', 'description': "The percentage of subjects in clinical remission at Week 2 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease."}, {'measure': 'Percentage of Subjects in Clinical Remission at Week 4', 'timeFrame': 'Week 4', 'description': "The percentage of subjects in clinical remission at Week 4 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease."}, {'measure': 'Percentage of Subjects Achieving a Clinical Response at Week 2', 'timeFrame': 'Week 0, Week 2', 'description': "The percentage of subjects achieving a clinical response at Week 2 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease."}, {'measure': 'Percentage of Subjects Achieving a Clinical Response at Week 4', 'timeFrame': 'Week 0, Week 4', 'description': "The percentage of subjects achieving a clinical response at Week 4 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease."}, {'measure': "Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2", 'timeFrame': 'Week 0 to Week 2', 'description': "The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 2. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease."}, {'measure': "Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 4", 'timeFrame': 'Week 0, Week 4', 'description': "The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 4. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease."}, {'measure': 'Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 2', 'timeFrame': 'Week 2', 'description': 'The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 2 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.'}, {'measure': 'Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 4', 'timeFrame': 'Week 4', 'description': 'The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 4 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.'}, {'measure': 'Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6', 'timeFrame': 'Week 6', 'description': "The percentage of subjects in the subgroup with less than 10 mg/L of C-reactive Protein (CRP) at Entry who are in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease."}, {'measure': 'Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6', 'timeFrame': 'Week 6', 'description': "The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease."}, {'measure': 'Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6', 'timeFrame': 'Week 0, Week 6', 'description': "The percentage of subjects in the subgroup with less than 10 mg/L C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease."}, {'measure': 'Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6', 'timeFrame': 'Week 0, Week 6', 'description': "The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CDP 870', 'Certolizumab Pegol', 'CIMZIA ®', "Crohn's disease", 'Induction', 'Clinical remission', 'Clinical response'], 'conditions': ['Crohn Disease']}, 'referencesModule': {'references': [{'pmid': '21642014', 'type': 'RESULT', 'citation': "Sandborn WJ, Schreiber S, Feagan BG, Rutgeerts P, Younes ZH, Bloomfield R, Coteur G, Guzman JP, D'Haens GR. Certolizumab pegol for active Crohn's disease: a placebo-controlled, randomized trial. Clin Gastroenterol Hepatol. 2011 Aug;9(8):670-678.e3. doi: 10.1016/j.cgh.2011.04.031. Epub 2011 May 13."}, {'pmid': '26031921', 'type': 'DERIVED', 'citation': "Sandborn WJ, Melmed GY, McGovern DP, Loftus EV Jr, Choi JM, Cho JH, Abraham B, Gutierrez A, Lichtenstein G, Lee SD, Randall CW, Schwartz DA, Regueiro M, Siegel CA, Spearman M, Kosutic G, Pierre-Louis B, Coarse J, Schreiber S. Clinical and demographic characteristics predictive of treatment outcomes for certolizumab pegol in moderate to severe Crohn's disease: analyses from the 7-year PRECiSE 3 study. Aliment Pharmacol Ther. 2015 Aug;42(3):330-42. doi: 10.1111/apt.13251. Epub 2015 Jun 1."}, {'pmid': '25146586', 'type': 'DERIVED', 'citation': "Sandborn WJ, Lee SD, Randall C, Gutierrez A, Schwartz DA, Ambarkhane S, Kayhan C, Pierre-Louis B, Schreiber S, Lichtenstein GR. Long-term safety and efficacy of certolizumab pegol in the treatment of Crohn's disease: 7-year results from the PRECiSE 3 study. Aliment Pharmacol Ther. 2014 Oct;40(8):903-16. doi: 10.1111/apt.12930. Epub 2014 Aug 22."}], 'seeAlsoLinks': [{'url': 'http://www.fda.gov/Safety/Recalls/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': "The primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing clinical remission in patients with moderate to severe Crohn's disease as compared with placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* male/female\n* 18 - 75 years inclusive\n* diagnosis of Crohn's disease confirmed\n* moderate to severe disease activity (Crohn's Disease Activity Index (CDAI) 225 - 450)\n* no previous treatment with anti-tumor necrosis factor (anti-TNF) medications\n\nExclusion Criteria:\n\n* previous participation in a certolizumab pegol study\n* general exclusion criteria 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