Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-03 @ 4:45 AM
Study NCT ID:
NCT02877134
Status:
COMPLETED
Last Update Posted:
2025-04-29
First Post:
2016-08-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Czechia', 'Italy', 'Serbia']}, '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': 'D000069549', 'term': 'Ustekinumab'}], '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': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'DIRECTOR CLINICAL RESEARCH GI', 'organization': 'Janssen Research & Development, LLC'}, 'certainAgreement': {'otherDetails': 'A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88', 'description': 'The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).', 'eventGroups': [{'id': 'EG000', 'title': 'Part I: Placebo', 'description': 'Participants received placebo subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo every 2 weeks (Q2W) through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 mg SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Safety results included data up to the time of receiving JNJ-64304500 for those who received JNJ-64304500 at Week 12 and included all data for those who did not receive JNJ-64304500 at Week 12. Participants were followed up for safety up to Week 38.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 24, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Part I: Placebo to JNJ-64304500', 'description': 'Participants received placebo SC at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo Q2W through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 mg SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Safety results included data from the time of receiving JNJ- 64304500 at Week 12 onward. Participants were followed up for safety up to Week 38.', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 10, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Part I: JNJ-64304500', 'description': 'Participants received JNJ-64304500 400 mg SC at Week 0 then 200 mg SC every two weeks through Week 22. Participants were followed up for safety up to Week 38.', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 38, 'seriousNumAtRisk': 73, 'deathsNumAffected': 1, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'Part II: Placebo', 'description': 'Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ 64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Safety results included data up to the time of receiving JNJ- 64304500 for those who received JNJ-64304500 at Week 12 and included all data for those who did not receive JNJ-64304500 at Week 12. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term extension (LTE) phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 16, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Part II: Placebo to JNJ-64304500 Middle Dose', 'description': 'Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ 64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Safety results included data from the time of receiving JNJ- 64304500 at Week 12 onward. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 6, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part II: JNJ-64304500 Low Dose', 'description': 'Participants received JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2 and 4, then 25 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 24, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG006', 'title': 'Part II: JNJ-64304500 Middle Dose', 'description': 'Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 23, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part II: JNJ-64304500 High Dose', 'description': 'Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 26, 'seriousNumAtRisk': 49, 'deathsNumAffected': 1, 'seriousNumAffected': 6}, {'id': 'EG008', 'title': 'Part II: Ustekinumab', 'description': 'Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously \\[IV\\]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight \\[less than or equal to \\[\\<=\\] 55 kg). - Ustekinumab 390 mg (weight greater than \\[\\>\\] 55 kg and less than or equal to \\[\\<=\\] 85 kg). Ustekinumab 520 mg (weight \\>85 kg). Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 20, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG009', 'title': 'Part II LTE: Placebo', 'description': 'Participants randomized to placebo group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received placebo at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 5, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG010', 'title': 'Part II LTE: Placebo to JNJ-64304500 Middle Dose', 'description': 'Participants randomized to placebo group and had dose adjustment to JNJ-64304500 middle dose at Week 12 and continued to receive JNJ-64304500 middle dose (JNJ-64304500 75 mg) SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72 in the Part II LTE. Participants were followed up for safety up to Week 88.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 5, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG011', 'title': 'Part II LTE: JNJ-64304500 Low Dose', 'description': "Participants randomized to the 'JNJ-64304500 Low Dose' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received JNJ-64304500 25 mg SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88.", 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 6, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG012', 'title': 'Part II LTE: JNJ-64304500 Middle Dose', 'description': "Participants randomized to the 'JNJ-64304500 Middle Dose' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received JNJ-64304500 75 mg SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88.", 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 12, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG013', 'title': 'Part II LTE: JNJ-64304500 High Dose', 'description': "Participants randomized to the 'JNJ-64304500 High Dose' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received JNJ-64304500 200 mg SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88.", 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 10, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG014', 'title': 'Part II LTE: Ustekinumab', 'description': "Participants randomized to the 'Ustekinumab' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received Ustekinumab 90 mg IV at Weeks 24, 32, 40, 48, 56, 64 and 72. Participants were followed up for safety up to Week 88.", 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 9, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Iron Deficiency Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 47, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': "Crohn's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG014', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Enterovesical Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Gastric Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 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'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Part I: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 8", 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part I: Placebo', 'description': 'Participants received placebo subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo every 2 weeks (Q2W) through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 milligrams (mg) SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Participants were followed up for safety up to Week 38.'}, {'id': 'OG001', 'title': 'Part I: JNJ-64304500', 'description': 'Participants received JNJ-64304500 400 mg SC at Week 0 then 200 mg SC every two weeks through Week 22. All participants were followed up for safety up to Week 38.'}], 'classes': [{'categories': [{'measurements': [{'value': '-60.0', 'spread': '77.08', 'groupId': 'OG000'}, {'value': '-103.6', 'spread': '93.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 8', 'description': "The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. The last 4 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analyses were based on the Full analysis set (FAS) included all randomized participants in Part 1 who received at least 1 dose of study agent.'}, {'type': 'PRIMARY', 'title': 'Part II: Change From Baseline in the CDAI Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part II: Placebo', 'description': 'Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term extension (LTE) phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG001', 'title': 'Part II: JNJ-64304500 Low Dose', 'description': 'Participants received JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2 and 4, then 25 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG002', 'title': 'Part II: JNJ-64304500 Middle Dose', 'description': 'Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG003', 'title': 'Part II: JNJ-64304500 High Dose', 'description': 'Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG004', 'title': 'Part II: Ustekinumab', 'description': 'Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously \\[IV\\]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight \\[less than or equal to \\[\\<=\\] 55 kg). - Ustekinumab 390 mg (weight greater than \\[\\>\\] 55 kg and less than or equal to \\[\\<=\\] 85 kg). Ustekinumab 520 mg (weight \\>85 kg). Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}], 'classes': [{'categories': [{'measurements': [{'value': '-59.2', 'spread': '89.51', 'groupId': 'OG000'}, {'value': '-93.2', 'spread': '117.91', 'groupId': 'OG001'}, {'value': '-72.2', 'spread': '92.79', 'groupId': 'OG002'}, {'value': '-84.3', 'spread': '103.28', 'groupId': 'OG003'}, {'value': '-148.8', 'spread': '84.59', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': "The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The last 4 variables are scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants in Part II who received at least 1 dose of study agent. Here 'N' refers to number of participants analyzed for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by CDAI (CDAI Less Than [<] 150)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part II: Placebo', 'description': 'Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term extension (LTE) phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG001', 'title': 'Part II: JNJ-64304500 Low Dose', 'description': 'Participants received JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2 and 4, then 25 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG002', 'title': 'Part II: JNJ-64304500 Middle Dose', 'description': 'Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG003', 'title': 'Part II: JNJ-64304500 High Dose', 'description': 'Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG004', 'title': 'Part II: Ustekinumab', 'description': 'Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously \\[IV\\]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight \\[less than or equal to \\[\\<=\\] 55 kg). - Ustekinumab 390 mg (weight greater than \\[\\>\\] 55 kg and less than or equal to \\[\\<=\\] 85 kg). Ustekinumab 520 mg (weight \\>85 kg). Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '18.4', 'groupId': 'OG002'}, {'value': '22.4', 'groupId': 'OG003'}, {'value': '53.2', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "Clinical Remission was defined as a CDAI score of \\<150 point. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. A decrease in CDAI over time indicates improvement in disease activity. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants in Part II who received at least 1 dose of study agent.'}, {'type': 'SECONDARY', 'title': 'Part II: Percentage of Participants in Clinical Response at Week 12 as Measured by CDAI (Greater Than or Equal to [>=] 100-point Reduction From Baseline in CDAI or CDAI <150)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part II: Placebo', 'description': 'Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term extension (LTE) phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG001', 'title': 'Part II: JNJ-64304500 Low Dose', 'description': 'Participants received JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2 and 4, then 25 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG002', 'title': 'Part II: JNJ-64304500 Middle Dose', 'description': 'Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG003', 'title': 'Part II: JNJ-64304500 High Dose', 'description': 'Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG004', 'title': 'Part II: Ustekinumab', 'description': 'Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously \\[IV\\]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight \\[less than or equal to \\[\\<=\\] 55 kg). - Ustekinumab 390 mg (weight greater than \\[\\>\\] 55 kg and less than or equal to \\[\\<=\\] 85 kg). Ustekinumab 520 mg (weight \\>85 kg). Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.9', 'groupId': 'OG000'}, {'value': '42.0', 'groupId': 'OG001'}, {'value': '40.8', 'groupId': 'OG002'}, {'value': '30.6', 'groupId': 'OG003'}, {'value': '72.3', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "Clinical response was defined as a \\>=100-point reduction from the baseline CDAI score, or a CDAI score \\<150. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants in Part II who received at least 1 dose of study agent.'}, {'type': 'SECONDARY', 'title': 'Part II: Change From Baseline in Patient-Reported Outcome (PRO)-2 at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part II: Placebo', 'description': 'Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term extension (LTE) phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG001', 'title': 'Part II: JNJ-64304500 Low Dose', 'description': 'Participants received JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2 and 4, then 25 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG002', 'title': 'Part II: JNJ-64304500 Middle Dose', 'description': 'Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG003', 'title': 'Part II: JNJ-64304500 High Dose', 'description': 'Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG004', 'title': 'Part II: Ustekinumab', 'description': 'Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously \\[IV\\]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight \\[less than or equal to \\[\\<=\\] 55 kg). - Ustekinumab 390 mg (weight greater than \\[\\>\\] 55 kg and less than or equal to \\[\\<=\\] 85 kg). Ustekinumab 520 mg (weight \\>85 kg). Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}], 'classes': [{'categories': [{'measurements': [{'value': '-28.8', 'spread': '47.72', 'groupId': 'OG000'}, {'value': '-46.1', 'spread': '59.14', 'groupId': 'OG001'}, {'value': '-39.8', 'spread': '52.59', 'groupId': 'OG002'}, {'value': '-42.9', 'spread': '47.33', 'groupId': 'OG003'}, {'value': '-70.1', 'spread': '52.97', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The PRO-2 score is defined as the sum of the abdominal pain and stool frequency components of the CDAI. PRO-2 scores ranges from 0 to approximately 300, higher score indicates higher disease activity.', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants in Part II who received at least 1 dose of study agent. Here 'N' refers to the number of participants analyzed for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by PRO-2 (PRO-2 <75)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part II: Placebo', 'description': 'Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term extension (LTE) phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG001', 'title': 'Part II: JNJ-64304500 Low Dose', 'description': 'Participants received JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2 and 4, then 25 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG002', 'title': 'Part II: JNJ-64304500 Middle Dose', 'description': 'Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG003', 'title': 'Part II: JNJ-64304500 High Dose', 'description': 'Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG004', 'title': 'Part II: Ustekinumab', 'description': 'Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously \\[IV\\]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight \\[less than or equal to \\[\\<=\\] 55 kg). - Ustekinumab 390 mg (weight greater than \\[\\>\\] 55 kg and less than or equal to \\[\\<=\\] 85 kg). Ustekinumab 520 mg (weight \\>85 kg). Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '32.0', 'groupId': 'OG001'}, {'value': '30.6', 'groupId': 'OG002'}, {'value': '44.9', 'groupId': 'OG003'}, {'value': '53.2', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Clinical Remission was defined as a PRO-2 score of \\<75 point.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants in Part II who received at least 1 dose of study agent.'}, {'type': 'SECONDARY', 'title': 'Part II: Percentage of Participants in Clinical Response at Week 12 as Measured by PRO-2 (>=50-point Reduction From Baseline in PRO-2 Score or PRO-2 Score <75)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part II: Placebo', 'description': 'Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term extension (LTE) phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG001', 'title': 'Part II: JNJ-64304500 Low Dose', 'description': 'Participants received JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2 and 4, then 25 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG002', 'title': 'Part II: JNJ-64304500 Middle Dose', 'description': 'Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG003', 'title': 'Part II: JNJ-64304500 High Dose', 'description': 'Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG004', 'title': 'Part II: Ustekinumab', 'description': 'Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously \\[IV\\]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight \\[less than or equal to \\[\\<=\\] 55 kg). - Ustekinumab 390 mg (weight greater than \\[\\>\\] 55 kg and less than or equal to \\[\\<=\\] 85 kg). Ustekinumab 520 mg (weight \\>85 kg). Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000'}, {'value': '44.0', 'groupId': 'OG001'}, {'value': '46.9', 'groupId': 'OG002'}, {'value': '49.0', 'groupId': 'OG003'}, {'value': '68.1', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Clinical response was defined as \\>=50-point reduction from baseline in PRO-2 or Score or PRO-2 Score \\<75.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants in Part II who received at least 1 dose of study agent.'}, {'type': 'SECONDARY', 'title': "Part II: Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part II: Placebo', 'description': 'Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term extension (LTE) phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG001', 'title': 'Part II: JNJ-64304500 Low Dose', 'description': 'Participants received JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2 and 4, then 25 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG002', 'title': 'Part II: JNJ-64304500 Middle Dose', 'description': 'Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG003', 'title': 'Part II: JNJ-64304500 High Dose', 'description': 'Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'OG004', 'title': 'Part II: Ustekinumab', 'description': 'Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously \\[IV\\]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight \\[less than or equal to \\[\\<=\\] 55 kg). - Ustekinumab 390 mg (weight greater than \\[\\>\\] 55 kg and less than or equal to \\[\\<=\\] 85 kg). Ustekinumab 520 mg (weight \\>85 kg). Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.2', 'spread': '6.58', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '6.47', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '4.89', 'groupId': 'OG002'}, {'value': '-2.7', 'spread': '6.93', 'groupId': 'OG003'}, {'value': '-2.6', 'spread': '5.32', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': "SES-CD is a validated instrument reflecting an endoscopist global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants in Part II who received at least 1 dose of study agent. Here 'N' refers to number of participants analyzed for this outcome measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part I: Placebo', 'description': 'Participants received placebo subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo every 2 weeks (Q2W) through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 milligrams (mg) SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Participants were followed up for safety up to Week 38.'}, {'id': 'FG001', 'title': 'Part I: JNJ-64304500', 'description': 'Participants received JNJ-64304500 400 mg SC at Week 0 then 200 mg SC every two weeks through Week 22. All participants were followed up for safety up to Week 38.'}, {'id': 'FG002', 'title': 'Part II: Placebo', 'description': 'Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term extension (LTE) phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'FG003', 'title': 'Part II: JNJ-64304500 Low Dose', 'description': 'Participants received JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2 and 4, then 25 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'FG004', 'title': 'Part II: JNJ-64304500 Middle Dose', 'description': 'Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'FG005', 'title': 'Part II: JNJ-64304500 High Dose', 'description': 'Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'FG006', 'title': 'Part II: Ustekinumab', 'description': 'Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously \\[IV\\]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight \\[less than or equal to \\[\\<=\\] 55 kg). - Ustekinumab 390 mg (weight greater than \\[\\>\\] 55 kg and less than or equal to \\[\\<=\\] 85 kg). Ustekinumab 520 mg (weight \\>85 kg). Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'FG007', 'title': 'Part II LTE: Placebo', 'description': 'Participants randomized to placebo group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received placebo or JNJ-64304500 middle dose (JNJ-64304500 75 mg SC) at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88.'}, {'id': 'FG008', 'title': 'Part II LTE: JNJ-64304500 Low Dose', 'description': "Participants randomized to the 'JNJ-64304500 Low Dose' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received JNJ-64304500 25 mg SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88."}, {'id': 'FG009', 'title': 'Part II LTE: JNJ-64304500 Middle Dose', 'description': "Participants randomized to the 'JNJ-64304500 Middle Dose' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received JNJ-64304500 75 mg SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88."}, {'id': 'FG010', 'title': 'Part II LTE: JNJ-64304500 High Dose', 'description': "Participants randomized to the 'JNJ-64304500 High Dose' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received JNJ-64304500 200 mg SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88."}, {'id': 'FG011', 'title': 'Part II LTE: Ustekinumab', 'description': "Participants randomized to the 'Ustekinumab' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received Ustekinumab 90 mg IV at Weeks 24, 32, 40, 48, 56, 64 and 72. Participants were followed up for safety up to Week 88."}], 'periods': [{'title': 'Main Study (Parts I,II): Up to Week 38', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '73'}, {'groupId': 'FG002', 'numSubjects': '48'}, {'groupId': 'FG003', 'numSubjects': '50'}, {'groupId': 'FG004', 'numSubjects': '49'}, {'groupId': 'FG005', 'numSubjects': '49'}, {'groupId': 'FG006', 'numSubjects': '47'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Placebo Non Responders at Week 12', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '35'}, {'groupId': 'FG004', 'numSubjects': '42'}, {'groupId': 'FG005', 'numSubjects': '39'}, {'groupId': 'FG006', 'numSubjects': '42'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}, {'title': 'Part II LTE Phase: From Week 24-88', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'comment': 'Only eligible participants from main study phase, entered into Part II LTE phase.', 'groupId': 'FG007', 'numSubjects': '22'}, {'comment': 'Only eligible participants from main study phase, entered into Part II LTE phase.', 'groupId': 'FG008', 'numSubjects': '21'}, {'comment': 'Only eligible participants from main study phase, entered into Part II LTE phase.', 'groupId': 'FG009', 'numSubjects': '27'}, {'comment': 'Only eligible participants from main study phase, entered into Part II LTE phase.', 'groupId': 'FG010', 'numSubjects': '24'}, {'comment': 'Only eligible participants from main study phase, entered into Part II LTE phase.', 'groupId': 'FG011', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '20'}, {'groupId': 'FG008', 'numSubjects': '17'}, {'groupId': 'FG009', 'numSubjects': '20'}, {'groupId': 'FG010', 'numSubjects': '14'}, {'groupId': 'FG011', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '4'}, {'groupId': 'FG009', 'numSubjects': '7'}, {'groupId': 'FG010', 'numSubjects': '10'}, {'groupId': 'FG011', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '9'}, {'groupId': 'FG011', 'numSubjects': '3'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'In participant flow, data is reported in 2 periods, \\[Main Study" and "Part II long term extension (LTE) Phase"\\] depicts the information for the specified time period as: Part I: Through Week 38 (including safety follow-up); Part II: Through Week 24 for participants who entered the LTE phase and through Week 36 for participants who did not enter the LTE.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}, {'value': '49', 'groupId': 'BG005'}, {'value': '47', 'groupId': 'BG006'}, {'value': '388', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Part I: Placebo', 'description': 'Participants received placebo subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo every 2 weeks (Q2W) through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 milligrams (mg) SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Participants were followed up for safety up to Week 38.'}, {'id': 'BG001', 'title': 'Part I: JNJ-64304500', 'description': 'Participants received JNJ-64304500 400 mg SC at Week 0 then 200 mg SC every two weeks through Week 22. All participants were followed up for safety up to Week 38.'}, {'id': 'BG002', 'title': 'Part II: Placebo', 'description': 'Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term extension (LTE) phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'BG003', 'title': 'Part II: JNJ-64304500 Low Dose', 'description': 'Participants received JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2 and 4, then 25 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'BG004', 'title': 'Part II: JNJ-64304500 Middle Dose', 'description': 'Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'BG005', 'title': 'Part II: JNJ-64304500 High Dose', 'description': 'Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'BG006', 'title': 'Part II: Ustekinumab', 'description': 'Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously \\[IV\\]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight \\[less than or equal to \\[\\<=\\] 55 kg). - Ustekinumab 390 mg (weight greater than \\[\\>\\] 55 kg and less than or equal to \\[\\<=\\] 85 kg). Ustekinumab 520 mg (weight \\>85 kg). Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.9', 'spread': '13.3', 'groupId': 'BG000'}, {'value': '38', 'spread': '13.25', 'groupId': 'BG001'}, {'value': '40.6', 'spread': '13.69', 'groupId': 'BG002'}, {'value': '36.4', 'spread': '11.14', 'groupId': 'BG003'}, {'value': '37.1', 'spread': '15.04', 'groupId': 'BG004'}, {'value': '37.2', 'spread': '12.87', 'groupId': 'BG005'}, {'value': '42', 'spread': '12.62', 'groupId': 'BG006'}, {'value': '38.5', 'spread': '13.2', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}, {'value': '174', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '29', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '214', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '33', 'groupId': 'BG007'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}, {'value': '39', 'groupId': 'BG005'}, {'value': '40', 'groupId': 'BG006'}, {'value': '343', 'groupId': 'BG007'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'BELGIUM', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}]}]}, {'title': 'BULGARIA', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}]}]}, {'title': 'FRANCE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}]}]}, {'title': 'GERMANY', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}]}]}, {'title': 'HUNGARY', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}]}, {'title': 'ITALY', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '13', 'groupId': 'BG007'}]}]}, {'title': 'JAPAN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '25', 'groupId': 'BG007'}]}]}, {'title': 'POLAND', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '72', 'groupId': 'BG007'}]}]}, {'title': 'ROMANIA', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}]}]}, {'title': 'RUSSIAN FEDERATION', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '109', 'groupId': 'BG007'}]}]}, {'title': 'SOUTH KOREA', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}]}]}, {'title': 'UKRAINE', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '80', 'groupId': 'BG007'}]}]}, {'title': 'UNITED KINGDOM', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}]}]}, {'title': 'UNITED STATES', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '42', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-04', 'size': 3995000, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-12-10T12:52', 'hasProtocol': True}, {'date': '2020-08-26', 'size': 2843351, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-12-10T12:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 388}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2016-08-19', 'resultsFirstSubmitDate': '2021-12-10', 'studyFirstSubmitQcDate': '2016-08-19', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-27', 'studyFirstPostDateStruct': {'date': '2016-08-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Part I: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 8", 'timeFrame': 'Baseline to Week 8', 'description': "The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. The last 4 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities."}, {'measure': 'Part II: Change From Baseline in the CDAI Score at Week 12', 'timeFrame': 'Baseline to Week 12', 'description': "The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The last 4 variables are scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities."}], 'secondaryOutcomes': [{'measure': 'Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by CDAI (CDAI Less Than [<] 150)', 'timeFrame': 'Week 12', 'description': "Clinical Remission was defined as a CDAI score of \\<150 point. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. A decrease in CDAI over time indicates improvement in disease activity. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities."}, {'measure': 'Part II: Percentage of Participants in Clinical Response at Week 12 as Measured by CDAI (Greater Than or Equal to [>=] 100-point Reduction From Baseline in CDAI or CDAI <150)', 'timeFrame': 'Week 12', 'description': "Clinical response was defined as a \\>=100-point reduction from the baseline CDAI score, or a CDAI score \\<150. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities."}, {'measure': 'Part II: Change From Baseline in Patient-Reported Outcome (PRO)-2 at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'The PRO-2 score is defined as the sum of the abdominal pain and stool frequency components of the CDAI. PRO-2 scores ranges from 0 to approximately 300, higher score indicates higher disease activity.'}, {'measure': 'Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by PRO-2 (PRO-2 <75)', 'timeFrame': 'Week 12', 'description': 'Clinical Remission was defined as a PRO-2 score of \\<75 point.'}, {'measure': 'Part II: Percentage of Participants in Clinical Response at Week 12 as Measured by PRO-2 (>=50-point Reduction From Baseline in PRO-2 Score or PRO-2 Score <75)', 'timeFrame': 'Week 12', 'description': 'Clinical response was defined as \\>=50-point reduction from baseline in PRO-2 or Score or PRO-2 Score \\<75.'}, {'measure': "Part II: Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12", 'timeFrame': 'Baseline, Week 12', 'description': "SES-CD is a validated instrument reflecting an endoscopist global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Crohn Disease']}, 'referencesModule': {'references': [{'pmid': '40357993', 'type': 'DERIVED', 'citation': "Hasskamp J, Meinhardt C, Timmer A. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2025 May 13;5(5):CD007572. doi: 10.1002/14651858.CD007572.pub4."}, {'pmid': '36939629', 'type': 'DERIVED', 'citation': "Allez M, Sands BE, Feagan BG, D'Haens G, De Hertogh G, Randall CW, Zou B, Johanns J, O'Brien C, Curran M, Rebuck R, Wang ML, Sabins N, Baker T, Kobayashi T. A Phase 2b, Randomised, Double-blind, Placebo-controlled, Parallel-arm, Multicenter Study Evaluating the Safety and Efficacy of Tesnatilimab in Patients with Moderately to Severely Active Crohn's Disease. J Crohns Colitis. 2023 Aug 21;17(8):1235-1251. doi: 10.1093/ecco-jcc/jjad047."}]}, 'descriptionModule': {'briefSummary': "The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants with moderately to severely active Crohn's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy\n* A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \\[b-hCG\\]) pregnancy test result at screening and a negative urine pregnancy test result at Week 0\n* Adhere to the following requirements for concomitant medication for the treatment of Crohn's disease, which are permitted provided that doses meeting these requirements are stable, or have been discontinued, for at least 3 weeks before baseline (Week 0), unless otherwise specified: a) Oral 5-aminosalicylic acid (5-ASA) compounds, b) Oral corticosteroids at a prednisone-equivalent dose at or below 40 milligram per day (mg/day), or 9 mg/day of budesonide, or 5 mg/day beclomethasone dipropionate, c) Antibiotics being used as a primary treatment of Crohn's disease, d) Conventional immunomodulators (that is, azathioprine (AZA), 6-mercaptopurine (6-MP), or Methotrexate (MTX)): participants must have been taking them for at least 12 weeks and at a stable dose for at least 4 weeks before baseline\n* A participant who has had extensive colitis for greater than or equal to (\\>=) 8 years, or disease limited to the left side of the colon for \\>= 12 years, must either have had a colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study agent or a colonoscopy to assess for the presence of malignancy at the screening visit, with no evidence of malignancy\n* Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index (CDAI) score of \\>= 220 but \\<= 450\n\nExclusion Criteria:\n\n* Participants who have received intravenous (IV) corticosteroids less then (\\<)3 weeks or have received tumor necrosis factor-alpha (TNF-alpha) antagonist biologic agents (example, monoclonal antibody \\[mAb\\] therapies) or other agents intended to suppress or eliminate tumor necrosis factor-alpha (TNF-alpha) \\<8 weeks or have received Vedolizumab \\<16 weeks before the first administration of study drug\n* Woman who is pregnant or planning pregnancy or is a man who plans to father while randomized in the study or within 16 weeks after the last administration of study agent\n* Participants with certain complications of Crohn's disease that would make it hard to assess response to study drug\n* Participants with a history of or ongoing chronic or recurrent infectious disease\n* Has previously received a biologic agent targeting interleukin (IL)-12 or IL-23, including but not limited to ustekinumab or briakinumab (ABT-874)"}, 'identificationModule': {'nctId': 'NCT02877134', 'acronym': 'TRIDENT', 'briefTitle': "Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': "A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's Disease", 'orgStudyIdInfo': {'id': 'CR108136'}, 'secondaryIdInfos': [{'id': '64304500CRD2001', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}, {'id': '2016-000634-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part I : Placebo', 'description': "Participants will receive placebo Subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. From Week 12 Placebo-treated participants who are in clinical response at Week 12 (\\>=100-point reduction from baseline in Crohn's Disease Activity Index (CDAI) or CDAI \\<150) will continue to receive placebo SC injections every 2 weeks from Week 12 through Week 22. Placebo -treated participants who are not in clinical response at Week 12 will receive JNJ-64304500 400 mg SC at Week 12 and then JNJ-64304500 200 mg every two weeks from Week 14 through Week 22.", 'interventionNames': ['Drug: JNJ-64304500', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part I : JNJ-64304500', 'description': 'Participants will receive JNJ-64304500 400 milligram (mg) SC at Week 0 then 200 mg SC every two weeks through Week 22.', 'interventionNames': ['Drug: JNJ-64304500']}, {'type': 'EXPERIMENTAL', 'label': 'Part II : Placebo', 'description': 'Placebo SC at Weeks 0, 2, 4, and 8. From Week 12, placebo-treated participants who are in clinical response at Week 12 (\\>=100-point reduction from baseline in CDAI or CDAI \\<150) will continue to receive placebo at Weeks 12, 14, 16, and 20. Placebo -treated participants who are not in clinical response at Week 12 will receive JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg at Weeks 14, 16, and 20. Participants who complete Part II 24 weeks assessment and may benefit from continued treatment in the opinion of the investigator are eligible to enter the Part II LTE in which they will continue to receive placebo up to 52 weeks (for a total of up to 72 weeks of placebo in Part II).\n\nThe study has been unblinded due to lack of sufficient efficacy of JNJ- 64304500. Participants receiving placebo during the LTE will stop receiving placebo.', 'interventionNames': ['Drug: JNJ-64304500', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part II : JNJ-64304500 High Dose', 'description': 'JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2, 4, 8, 12, 16, and 20. Participants who complete Part II 24 weeks assessment and may benefit from continued treatment in the opinion of the investigator are eligible to enter the Part II LTE in which they will continue to receive JNJ-64304500 high dose up to 52 weeks (for a total of up to 72 weeks of JNJ-64304500 in Part II).\n\nThe study has been unblinded due to lack of sufficient efficacy of JNJ-64304500. Participants receiving JNJ-64304500 during the LTE will stop receiving study drug and will have a final safety follow-up visit 16 weeks after the last dose of study drug.', 'interventionNames': ['Drug: JNJ-64304500']}, {'type': 'EXPERIMENTAL', 'label': 'Part II : JNJ-64304500 Middle Dose', 'description': 'JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2, 4, 8, 12, 16, and 20. Participants who complete Part II 24 weeks assessment and may benefit from continued treatment in the opinion of the investigator are eligible to enter the Part II LTE in which they will continue to receive JNJ-64304500 middle dose up to 52 weeks (for a total of up to 72 weeks of JNJ-64304500 in Part II).\n\nThe study has been unblinded due to lack of sufficient efficacy of JNJ-64304500. Participants receiving JNJ-64304500 during the LTE will stop receiving study drug and will have a final safety follow-up visit 16 weeks after the last dose of study drug.', 'interventionNames': ['Drug: JNJ-64304500']}, {'type': 'EXPERIMENTAL', 'label': 'Part II : JNJ-64304500 Low Dose', 'description': 'JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2, 4, 8, 12, 16, and 20. Participants who complete Part II 24 weeks assessment and may benefit from continued treatment in the opinion of the investigator are eligible to enter the Part II LTE in which they will continue to receive JNJ-64304500 low dose up to 52 weeks (for a total of up to 72 weeks of JNJ-64304500 in Part II).\n\nThe study has been unblinded due to lack of sufficient efficacy of JNJ-64304500. Participants receiving JNJ-64304500 during the LTE will stop receiving study drug and will have a final safety follow-up visit 16 weeks after the last dose of study drug.', 'interventionNames': ['Drug: JNJ-64304500']}, {'type': 'EXPERIMENTAL', 'label': 'Part II : Ustekinumab', 'description': "Participants will receive tiered doses of Ustekinumab 260 mg (weight \\<=55 kg), Ustekinumab 390 mg (weight \\>55 kg and \\<=85 kg), Ustekinumab 520 mg (weight \\>85 kg) intravenously at Week 0 followed by 90 mg subcutaneously at Weeks 8 and 16. Participants who complete Part II 24 weeks assessment and may benefit from continued treatment in the opinion of the investigator are eligible to enter the Part II LTE in which they will continue to receive Ustekinumab up to 52 weeks (for a total of up to 72 weeks of Ustekinumab in Part II).\n\nThe study has been unblinded due to lack of sufficient efficacy of JNJ-64304500. Participants receiving Ustekinumab during the LTE will stop receiving study drug and will have a final safety follow-up visit after the last dose of study drug. However, participants receiving Ustekinumab in countries where Ustekinumab is not commercially available or approved for adult Crohn's disease were continued to receive Ustekinumab in the LTE.", 'interventionNames': ['Drug: Ustekinumab']}], 'interventions': [{'name': 'JNJ-64304500', 'type': 'DRUG', 'description': 'Participants will receive JNJ-64304500 Subcutaneously.', 'armGroupLabels': ['Part I : JNJ-64304500', 'Part I : Placebo', 'Part II : JNJ-64304500 High Dose', 'Part II : JNJ-64304500 Low Dose', 'Part II : JNJ-64304500 Middle Dose', 'Part II : Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will receive placebo Subcutaneously.', 'armGroupLabels': ['Part I : Placebo', 'Part II : Placebo']}, {'name': 'Ustekinumab', 'type': 'DRUG', 'otherNames': ['STELARA'], 'description': 'Participants will receive ustekinumab as per the dosing regimen.', 'armGroupLabels': ['Part II : Ustekinumab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lone Tree', 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