Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2026-01-04 @ 3:45 AM
Study NCT ID:
NCT02871635
Status:
COMPLETED
Last Update Posted:
2020-06-04
First Post:
2016-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
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': 'C000632724', 'term': 'BI 695501'}, {'id': 'D000068879', 'term': 'Adalimumab'}], 'ancestors': [{'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': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.', 'description': 'The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.', 'eventGroups': [{'id': 'EG000', 'title': 'BI 695501 (Baseline - Week 24 + 10 Weeks [70 Days])', 'description': 'Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (CDAI decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).\n\nPatients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 23, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Humira (Baseline - Week 24 + 10 Weeks [70 Days])', 'description': 'Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).\n\nPatients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 16, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'BI 695501 (Week 24 - Week 46 + 10 Weeks [70 Days])', 'description': 'Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (CDAI decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).\n\nPatients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 13, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Humira (Week 24 - Week 46 + 10 Weeks [70 Days])', 'description': 'Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).\n\nPatients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 12, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'seriousEvents': [{'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Psoas abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Rotavirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Multiple sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Large intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pancreatitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Ruptured ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Palmoplantar pustulosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pyoderma gangrenosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 695501', 'description': "Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).\n\nPatients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection."}, {'id': 'OG001', 'title': 'Humira EU', 'description': 'Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).\n\nPatients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000'}, {'value': '93.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.945', 'ciLowerLimit': '0.870', 'ciUpperLimit': '1.028', 'estimateComment': 'BI 695501 as numerator Humira EU as denominator', 'groupDescription': "Was analyzed using a log-linked binomial model, described as: response to treatment at Week 4 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)", 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.945', 'ciLowerLimit': '0.856', 'ciUpperLimit': '1.044', 'estimateComment': 'BI 695501 as numerator Humira EU as denominator', 'groupDescription': "Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 4 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)", 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': "The Crohn's Disease Activity Index (CDAI) is a validated instrument to measure disease severity in Crohn's Disease (CD). The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease.\n\nThe CDAI decrease at Week 4 was assessed as the decrease relative to baseline measurement, patients with a decrease ≥70 were responders.\n\nPercentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to non-responder imputation (NRI) and last observation carried forward (LOCF).", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) contained all randomized patients who received at least 1 dose of trial medication, and had all efficacy measures relevant for the CDAI, measured at baseline and at least once postbaseline.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 695501', 'description': "Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).\n\nPatients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection."}, {'id': 'OG001', 'title': 'Humira EU', 'description': 'Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).\n\nPatients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.4', 'groupId': 'OG000'}, {'value': '87.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.000', 'ciLowerLimit': '0.871', 'ciUpperLimit': '1.148', 'estimateComment': 'BI 695501 as numerator Humira EU as denominator', 'groupDescription': "Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)", 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.000', 'ciLowerLimit': '0.848', 'ciUpperLimit': '1.178', 'estimateComment': 'BI 695501 as numerator Humira EU as denominator', 'groupDescription': "Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)", 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'The CDAI is a validated instrument to measure disease severity in CD. The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease.\n\nThe CDAI decrease at Week 24 was assessed as the decrease relative to baseline measurement, patients with a decrease ≥70 were responders.\n\nPercentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to NRI and LOCF.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS contained all randomized patients who received at least 1 dose of trial medication, and had all efficacy measures relevant for the CDAI, measured at baseline and at least once postbaseline.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients in Clinical Remission (CDAI <150) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 695501', 'description': "Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).\n\nPatients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection."}, {'id': 'OG001', 'title': 'Humira EU', 'description': 'Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).\n\nPatients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.6', 'groupId': 'OG000'}, {'value': '76.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.900', 'ciLowerLimit': '0.751', 'ciUpperLimit': '1.078', 'estimateComment': 'BI 695501 as numerator Humira EU as denominator', 'groupDescription': "Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)", 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9000', 'ciLowerLimit': '0.725', 'ciUpperLimit': '1.116', 'estimateComment': 'BI 695501 as numerator Humira EU as denominator', 'groupDescription': "Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)", 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'at Week 24', 'description': 'The CDAI is a validated instrument to measure disease severity in CD. The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease.\n\nPatients with CDAI \\<150 at Week 24 were considered as clinical remission cases. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to NRI and LOCF.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS contained all randomized patients who received at least 1 dose of trial medication, and had all efficacy measures relevant for the CDAI, measured at baseline and at least once postbaseline.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 695501', 'description': "Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).\n\nPatients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection."}, {'id': 'OG001', 'title': 'Humira EU', 'description': 'Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).\n\nPatients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.'}], 'classes': [{'title': 'TEAE -Period 1', 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000'}, {'value': '56.0', 'groupId': 'OG001'}]}]}, {'title': 'serious TEAE - Period 1', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}]}]}, {'title': 'AESI TEAE - Period 1', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'TEAE - Period 2', 'categories': [{'measurements': [{'value': '43.1', 'groupId': 'OG000'}, {'value': '45.3', 'groupId': 'OG001'}]}]}, {'title': 'serious TEAE - Period 2', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '12.0', 'groupId': 'OG001'}]}]}, {'title': 'AESI TEAE - Period 2', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.', 'description': "Analysis of AEs focused on treatment-emergent AEs (TEAEs). For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46. TEAEs and SAEs (including investigator-assessed trial medication-related TEAEs) and AESIs are reported. The following were considered an AESI: hepatic injury, anaphylactic reactions, serious infection and hypersensitivity reactions.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 695501', 'description': "Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).\n\nPatients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection."}, {'id': 'OG001', 'title': 'Humira EU', 'description': 'Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).\n\nPatients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.'}], 'classes': [{'title': 'Period 1', 'categories': [{'measurements': [{'value': '23.6', 'groupId': 'OG000'}, {'value': '22.7', 'groupId': 'OG001'}]}]}, {'title': 'Period 2', 'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000'}, {'value': '22.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.', 'description': "The percentage of patients with TEAEs for infections are reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SAF contained all randomized patients who received at least 1 dose (full or partial) of trial medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Serious Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 695501', 'description': "Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).\n\nPatients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection."}, {'id': 'OG001', 'title': 'Humira EU', 'description': 'Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).\n\nPatients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.'}], 'classes': [{'title': 'Period 1', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Period 2', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '4.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.', 'description': "The percentage of patients with TEAEs for serious infections are reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SAF contained all randomized patients who received at least 1 dose (full or partial) of trial medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Experienced Hypersensitivity Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 695501', 'description': "Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).\n\nPatients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection."}, {'id': 'OG001', 'title': 'Humira EU', 'description': 'Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).\n\nPatients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.'}], 'classes': [{'title': 'Period 1', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}, {'value': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Period 2', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '6.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.', 'description': "The percentage of patients with TEAEs for hypersensitivity reactions is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SAF contained all randomized patients who received at least 1 dose (full or partial) of trial medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Experienced Drug Induced Liver Injury (DILI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 695501', 'description': "Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).\n\nPatients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection."}, {'id': 'OG001', 'title': 'Humira EU', 'description': 'Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).\n\nPatients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.'}], 'classes': [{'title': 'Period 1', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Period 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.', 'description': "The percentage of patients with TEAEs for DILIs is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SAF contained all randomized patients who received at least 1 dose (full or partial) of trial medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Injection Site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 695501', 'description': "Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).\n\nPatients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection."}, {'id': 'OG001', 'title': 'Humira EU', 'description': 'Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).\n\nPatients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.'}], 'classes': [{'title': 'Period 1', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '6.7', 'groupId': 'OG001'}]}]}, {'title': 'Period 2', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.', 'description': "The percentage of patients with TEAEs for injection site reactions is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SAF contained all randomized patients who received at least 1 dose (full or partial) of trial medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BI 695501', 'description': "Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).\n\nPatients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection."}, {'id': 'FG001', 'title': 'Humira EU', 'description': 'Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).\n\nPatients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Primary lack of efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Secondary lack of efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': "This was an exploratory, randomized, 56-week, double-blind, parallel arm, multiple dose, active comparator trial of BI 695501 and EU-approved Humira, with a 48-week treatment period and a 10-week follow-up period (starting after last dose of trial medication at Week 46) in patients with moderately to severely active Crohn's Disease (CD)", 'preAssignmentDetails': 'The trial consisted of a screening period of up to a maximum of 28 days, a 48-week treatment period consisting of an induction period from baseline to Week 4 and a maintenance period from Week 5 to Week 48, and a 10-week safety follow-up period (starting after last dose of trial medication at Week 46).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BI 695501', 'description': "Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).\n\nPatients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection."}, {'id': 'BG001', 'title': 'Humira EU', 'description': 'Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).\n\nPatients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.4', 'spread': '13.44', 'groupId': 'BG000'}, {'value': '33.2', 'spread': '11.52', 'groupId': 'BG001'}, {'value': '35.3', 'spread': '12.63', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "Crohn's Disease Activity Index score at baseline", 'classes': [{'categories': [{'measurements': [{'value': '307.3', 'spread': '76.69', 'groupId': 'BG000'}, {'value': '303.6', 'spread': '64.39', 'groupId': 'BG001'}, {'value': '305.4', 'spread': '70.46', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Crohn's Disease Activity Index (CDAI) is a valid instrument to measure severity in Crohn's disease. The CDAI is composed of 8 factors (Number of liquid stools, abdominal pain, general well being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit, body weight) the score is calculated by adding up the scores after adjustment with a weighting factor. The total score ranges from 0 to approx. 600, higher scores indicates more severe disease. A score of less than or equal to 150 is evaluated as a remission while 220 and 450 indicate moderate to severely active disease.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-12', 'size': 859806, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-04-23T04:44', 'hasProtocol': True}, {'date': '2019-05-22', 'size': 848739, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-04-23T04:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-29', 'studyFirstSubmitDate': '2016-08-15', 'resultsFirstSubmitDate': '2020-04-23', 'studyFirstSubmitQcDate': '2016-08-15', 'lastUpdatePostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-29', 'studyFirstPostDateStruct': {'date': '2016-08-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 4', 'timeFrame': 'Week 4', 'description': "The Crohn's Disease Activity Index (CDAI) is a validated instrument to measure disease severity in Crohn's Disease (CD). The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease.\n\nThe CDAI decrease at Week 4 was assessed as the decrease relative to baseline measurement, patients with a decrease ≥70 were responders.\n\nPercentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to non-responder imputation (NRI) and last observation carried forward (LOCF)."}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 24', 'timeFrame': 'Week 24', 'description': 'The CDAI is a validated instrument to measure disease severity in CD. The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease.\n\nThe CDAI decrease at Week 24 was assessed as the decrease relative to baseline measurement, patients with a decrease ≥70 were responders.\n\nPercentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to NRI and LOCF.'}, {'measure': 'Percentage of Patients in Clinical Remission (CDAI <150) at Week 24', 'timeFrame': 'at Week 24', 'description': 'The CDAI is a validated instrument to measure disease severity in CD. The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease.\n\nPatients with CDAI \\<150 at Week 24 were considered as clinical remission cases. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to NRI and LOCF.'}, {'measure': 'Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs)', 'timeFrame': 'From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.', 'description': "Analysis of AEs focused on treatment-emergent AEs (TEAEs). For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46. TEAEs and SAEs (including investigator-assessed trial medication-related TEAEs) and AESIs are reported. The following were considered an AESI: hepatic injury, anaphylactic reactions, serious infection and hypersensitivity reactions."}, {'measure': 'Percentage of Patients With Infections', 'timeFrame': 'From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.', 'description': "The percentage of patients with TEAEs for infections are reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46."}, {'measure': 'Percentage of Patients With Serious Infections', 'timeFrame': 'From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.', 'description': "The percentage of patients with TEAEs for serious infections are reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46."}, {'measure': 'Percentage of Patients Who Experienced Hypersensitivity Reactions', 'timeFrame': 'From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.', 'description': "The percentage of patients with TEAEs for hypersensitivity reactions is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46."}, {'measure': 'Percentage of Patients Who Experienced Drug Induced Liver Injury (DILI)', 'timeFrame': 'From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.', 'description': "The percentage of patients with TEAEs for DILIs is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46."}, {'measure': 'Percentage of Patients With Injection Site Reactions', 'timeFrame': 'From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.', 'description': "The percentage of patients with TEAEs for injection site reactions is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46."}]}, 'conditionsModule': {'conditions': ['Crohn Disease']}, 'referencesModule': {'references': [{'pmid': '40498294', 'type': 'DERIVED', 'citation': "Strand V. Summary of Research: Immunogenicity of Adalimumab Reference Product and Adalimumab-adbm in Patients with Rheumatoid Arthritis, Crohn's Disease, and Chronic Plaque Psoriasis: A Pooled Analysis of the VOLTAIRE trials. Rheumatol Ther. 2025 Aug;12(4):613-616. doi: 10.1007/s40744-025-00766-6. Epub 2025 Jun 11."}, {'pmid': '39551590', 'type': 'DERIVED', 'citation': "Strand V, McCabe D, Bender S. Immunogenicity of adalimumab reference product and adalimumab-adbm in patients with rheumatoid arthritis, Crohn's disease and chronic plaque psoriasis: a pooled analysis of the VOLTAIRE trials. BMJ Open. 2024 Nov 17;14(11):e081687. doi: 10.1136/bmjopen-2023-081687."}, {'pmid': '36511191', 'type': 'DERIVED', 'citation': "Hanauer S. Plain language summary of the VOLTAIRE-CD study in people with moderate-to-severe active Crohn's disease. Immunotherapy. 2022 Dec;14(17):1353-1359. doi: 10.2217/imt-2022-0129. Epub 2022 Dec 13."}, {'pmid': '34388360', 'type': 'DERIVED', 'citation': "Hanauer S, Liedert B, Balser S, Brockstedt E, Moschetti V, Schreiber S. Safety and efficacy of BI 695501 versus adalimumab reference product in patients with advanced Crohn's disease (VOLTAIRE-CD): a multicentre, randomised, double-blind, phase 3 trial. Lancet Gastroenterol Hepatol. 2021 Oct;6(10):816-825. doi: 10.1016/S2468-1253(21)00252-1. Epub 2021 Aug 11."}]}, 'descriptionModule': {'briefSummary': "Primary Objective:\n\nThe primary objective of this trial is to compare the clinical efficacy of BI 695501 with EU-approved Humira® in patients with active Crohn's disease (CD).\n\nSecondary Objectives:\n\nThe secondary objectives of this trial are to compare the efficacy and safety of BI 695501 with EU-approved Humira® across the induction and maintenance phases."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Males and females aged \\>=18 and =\\<80 years at Screening who have a diagnosis of moderate to severely active Crohn's Disease (CD), confirmed by endoscopy or radiologic evaluation, for more than 4 months with evidence of mucosal ulceration. Patients must have all of the following:\n\n * Crohn's Disease Activity Index (CDAI) score of \\>=220 and =\\<450\n * A diagnosis of Crohn's Disease (CD) confirmed by ileocolonoscopy during Screening\n * Presence of mucosal ulcers in at least one segment of the ileum or colon and a SES-CD score ≥7 (for patients with isolated ileal disease SES-CD score ≥4), as assessed by ileocolonoscopy and confirmed by central independent reviewer(s) before randomization\n* Anti-tumor necrosis factor (TNF) patients or patients previously treated with infliximab who had initially responded and who meet one of the following criteria:\n\n * Responded and developed secondary resistance due confirmed anti-infliximab anti-drug antibody formation, which caused infliximab depletion\n * Responded and became intolerant\n* Further inclusion criteria apply\n\nExclusion criteria:\n\n* Patients with ulcerative colitis or indeterminate colitis\n* Patients with symptomatic known obstructive strictures\n* Surgical bowel resection performed within 6 months prior to Screening or planned resection at any time while enrolled in the trial\n* Patients with an ostomy or ileoanal pouch\n* Patients with short bowel syndrome\n* Patients who have previously used infliximab and have never clinically responded\n* Patients who have previously received treatment with adalimumab, or who have participated in an adalimumab or adalimumab biosimilar clinical trial\n* Further exclusion criteria apply"}, 'identificationModule': {'nctId': 'NCT02871635', 'briefTitle': "BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity", 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': "BI 695501 Versus Humira® in Patients With Active Crohn's Disease: a Randomized, Double-blind, Multicenter, Parallel Group, Exploratory Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity", 'orgStudyIdInfo': {'id': '1297.4'}, 'secondaryIdInfos': [{'id': '2016-000612-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI 695501', 'interventionNames': ['Drug: BI 695501']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HUMIRA + BI 695501', 'interventionNames': ['Drug: BI 695501', 'Drug: HUMIRA']}], 'interventions': [{'name': 'BI 695501', 'type': 'DRUG', 'armGroupLabels': ['BI 695501', 'HUMIRA + BI 695501']}, {'name': 'HUMIRA', 'type': 'DRUG', 'armGroupLabels': ['HUMIRA + BI 695501']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Borland-Groover Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '34741', 'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'facility': 'Hope Clinical Research', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Advanced GI', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Advance Medical Research Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34653', 'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Research Institute, Inc', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '30344', 'city': 'East Point', 'state': 'Georgia', 'country': 'United States', 'facility': 'Doctors Clinical Research', 'geoPoint': {'lat': 33.67955, 'lon': -84.43937}}, {'zip': '60453', 'city': 'Oak Lawn', 'state': 'Illinois', 'country': 'United States', 'facility': 'Southwest Gastroenterology', 'geoPoint': {'lat': 41.71087, 'lon': -87.75811}}, {'zip': '66160-7702', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'MGG Group Co. Inc. / Chevy Chase Clinical Research,', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '21045', 'city': 'Columbia', 'state': 'Maryland', 'country': 'United States', 'facility': 'Gastro Center of Maryland', 'geoPoint': {'lat': 39.24038, 'lon': -76.83942}}, {'zip': '63042', 'city': 'Hazelwood', 'state': 'Missouri', 'country': 'United States', 'facility': 'Healthcare Research Network', 'geoPoint': {'lat': 38.77144, 'lon': -90.37095}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Asheville Gastroenterology Associates, PA', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '44060', 'city': 'Mentor', 'state': 'Ohio', 'country': 'United States', 'facility': 'Great Lakes Gastroenterology Research, LLC', 'geoPoint': {'lat': 41.66616, 'lon': -81.33955}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Gastroenterology Associates, PA', 'geoPoint': {'lat': 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'Gomel Regional Clinical', 'geoPoint': {'lat': 52.4345, 'lon': 30.9754}}, {'zip': '220096', 'city': 'Minsk', 'country': 'Belarus', 'facility': 'City Clinical Hospital # 10', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'zip': '210603', 'city': 'Vitebsk', 'country': 'Belarus', 'facility': 'Vitebsk Regional Clinical Oncology Dispensary', 'geoPoint': {'lat': 55.1904, 'lon': 30.2049}}, {'zip': '71000', 'city': 'Sarajevo', 'country': 'Bosnia and Herzegovina', 'facility': 'University Clinical Centre Sarajevo', 'geoPoint': {'lat': 43.84864, 'lon': 18.35644}}, {'zip': '31000', 'city': 'Osijek', 'country': 'Croatia', 'facility': 'Clinical Hospital Osijek', 'geoPoint': {'lat': 45.55066, 'lon': 18.6942}}, {'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Polyclinic Bonifarm', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '63600', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Vojenska nemocnice Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '50012', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Hepato-Gastroenterologie HK, s.r.o.', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '779 00', 'city': 'Olomouc', 'country': 'Czechia', 'facility': 'CTCenter Mave, s.r.o., Cllinical Trials Center, Olomouc', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '779 00', 'city': 'Olomouc', 'country': 'Czechia', 'facility': 'Gregar s.r.o.', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '77900', 'city': 'Olomouc', 'country': 'Czechia', 'facility': 'PreventaMed, s.r.o.', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '708 52', 'city': 'Ostrava-Poruba', 'country': 'Czechia', 'facility': 'University Hospital Ostrava'}, {'zip': '703 84', 'city': 'Ostrava-Vitkovice', 'country': 'Czechia', 'facility': 'Vitkovice Hospital'}, {'zip': '140 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Medicon, a.s.', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '15000', 'city': 'Prague', 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