Trial Outcomes & Findings for A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (NCT NCT03662542)
NCT ID: NCT03662542
Last Updated: 2023-12-12
Results Overview
Clinical response was defined as a decrease from baseline in the Mayo score greater than or equal to (\>=) 30 percent (%) and \>=3 points with either a decrease from baseline in the rectal bleeding subscore (RBS) \>=1 or a RBS of 0 or 1. The Mayo score was calculated as the sum of 4 subscores (stool frequency, rectal bleeding, physician's global assessment, and endoscopy findings - each with score range of 0 (normal activity) to 3 (severe activity) and a total score range of 0 to 12 points. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease. Higher scores indicate more severity. This outcome measure was analyzed for combination phase only as preplanned in the protocol.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
214 participants
Primary outcome timeframe
Week 12
Results posted on
2023-12-12
Participant Flow
Participant milestones
| Measure |
Combination Phase: Golimumab Monotherapy
Participants received golimumab 200 milligrams (mg) as subcutaneous (SC) injection at Week 0, followed by golimumab 100 mg as SC injection at Weeks 2, 6 and 10. Participants received placebo as intravenous (IV) infusion at Weeks 0, 4 and 8 to maintain the blind. Participants were then assessed for efficacy at Week 10 and Week 12.
|
Combination Phase: Guselkumab Monotherapy
Participants received guselkumab 200 mg as IV infusion at Weeks 0, 4 and 8. Participants received placebo as SC injection at Weeks 0, 2, 6 and 10 to maintain the blind. Participants were then assessed for efficacy at Week 10 and Week 12.
|
Combination Phase: Combination Therapy
Participants received guselkumab 200 mg as IV infusion at Weeks 0, 4, and 8. Participants received golimumab 200 mg as SC injection at Week 0, followed by golimumab 100 mg as SC injection at Weeks 2, 6 and 10. Participants were then assessed for efficacy at Week 10 and Week 12.
|
Monotherapy Phase: Golimumab Monotherapy
Participants received golimumab 100 mg as SC injection at Weeks 14, 18, 22, 26, 30 and 34, and placebo as SC injection at Weeks 16, 24, and 32 to maintain the blind. Participants were then assessed for efficacy at Week 38.
|
Monotherapy Phase: Guselkumab Monotherapy
Participants received guselkumab 100 mg as SC injection at Weeks 16, 24, and 32, and placebo as SC injection at Weeks 14, 18, 22, 26, 30, and 34 to maintain the blind. Participants were then assessed for efficacy at Week 38.
|
Monotherapy Phase: Combination Therapy
Participants received guselkumab 100 mg as SC injection at Weeks 16, 24 and 32, and placebo as SC injection at Weeks 14, 18, 22, 26, 30, and 34 to maintain the blind. Participants were then assessed for efficacy at Week 38.
|
Safety Follow-up: Golimumab Monotherapy
Participants were followed up for safety from Week 38 to Week 50 (end of study \[EOS\]) and did not receive any additional medication in the safety follow-up phase.
|
Safety Follow-up: Guselkumab Monotherapy
Participants were followed up for safety from Week 38 to Week 50 (EOS) and did not receive any additional medication in the safety follow-up phase.
|
Safety Follow-up: Combination Therapy
Participants were followed up for safety from Week 38 to Week 50 (EOS) and did not receive any additional medication in the safety follow-up phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Combination Phase ( Week 0- Week 12)
STARTED
|
72
|
71
|
71
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Combination Phase ( Week 0- Week 12)
COMPLETED
|
67
|
70
|
71
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Combination Phase ( Week 0- Week 12)
NOT COMPLETED
|
5
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Monotherapy Phase (Week 12-Week 38)
STARTED
|
0
|
0
|
0
|
67
|
70
|
71
|
0
|
0
|
0
|
|
Monotherapy Phase (Week 12-Week 38)
COMPLETED
|
0
|
0
|
0
|
62
|
67
|
65
|
0
|
0
|
0
|
|
Monotherapy Phase (Week 12-Week 38)
NOT COMPLETED
|
0
|
0
|
0
|
5
|
3
|
6
|
0
|
0
|
0
|
|
Safety Follow-up (Week 38- Week 50)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
58
|
65
|
60
|
|
Safety Follow-up (Week 38- Week 50)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
55
|
58
|
55
|
|
Safety Follow-up (Week 38- Week 50)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
7
|
5
|
Reasons for withdrawal
| Measure |
Combination Phase: Golimumab Monotherapy
Participants received golimumab 200 milligrams (mg) as subcutaneous (SC) injection at Week 0, followed by golimumab 100 mg as SC injection at Weeks 2, 6 and 10. Participants received placebo as intravenous (IV) infusion at Weeks 0, 4 and 8 to maintain the blind. Participants were then assessed for efficacy at Week 10 and Week 12.
|
Combination Phase: Guselkumab Monotherapy
Participants received guselkumab 200 mg as IV infusion at Weeks 0, 4 and 8. Participants received placebo as SC injection at Weeks 0, 2, 6 and 10 to maintain the blind. Participants were then assessed for efficacy at Week 10 and Week 12.
|
Combination Phase: Combination Therapy
Participants received guselkumab 200 mg as IV infusion at Weeks 0, 4, and 8. Participants received golimumab 200 mg as SC injection at Week 0, followed by golimumab 100 mg as SC injection at Weeks 2, 6 and 10. Participants were then assessed for efficacy at Week 10 and Week 12.
|
Monotherapy Phase: Golimumab Monotherapy
Participants received golimumab 100 mg as SC injection at Weeks 14, 18, 22, 26, 30 and 34, and placebo as SC injection at Weeks 16, 24, and 32 to maintain the blind. Participants were then assessed for efficacy at Week 38.
|
Monotherapy Phase: Guselkumab Monotherapy
Participants received guselkumab 100 mg as SC injection at Weeks 16, 24, and 32, and placebo as SC injection at Weeks 14, 18, 22, 26, 30, and 34 to maintain the blind. Participants were then assessed for efficacy at Week 38.
|
Monotherapy Phase: Combination Therapy
Participants received guselkumab 100 mg as SC injection at Weeks 16, 24 and 32, and placebo as SC injection at Weeks 14, 18, 22, 26, 30, and 34 to maintain the blind. Participants were then assessed for efficacy at Week 38.
|
Safety Follow-up: Golimumab Monotherapy
Participants were followed up for safety from Week 38 to Week 50 (end of study \[EOS\]) and did not receive any additional medication in the safety follow-up phase.
|
Safety Follow-up: Guselkumab Monotherapy
Participants were followed up for safety from Week 38 to Week 50 (EOS) and did not receive any additional medication in the safety follow-up phase.
|
Safety Follow-up: Combination Therapy
Participants were followed up for safety from Week 38 to Week 50 (EOS) and did not receive any additional medication in the safety follow-up phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Combination Phase ( Week 0- Week 12)
Withdrawal by Subject
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Combination Phase ( Week 0- Week 12)
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Combination Phase ( Week 0- Week 12)
Other
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Combination Phase ( Week 0- Week 12)
COVID-19
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Monotherapy Phase (Week 12-Week 38)
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Monotherapy Phase (Week 12-Week 38)
Lost to Follow-up
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Monotherapy Phase (Week 12-Week 38)
Withdrawal by Subject
|
0
|
0
|
0
|
4
|
1
|
1
|
0
|
0
|
0
|
|
Monotherapy Phase (Week 12-Week 38)
Other
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
|
Monotherapy Phase (Week 12-Week 38)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Safety Follow-up (Week 38- Week 50)
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Safety Follow-up (Week 38- Week 50)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Safety Follow-up (Week 38- Week 50)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
|
Safety Follow-up (Week 38- Week 50)
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
6
|
2
|
Baseline Characteristics
A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Golimumab Monotherapy
n=72 Participants
Participants received golimumab 200 milligrams (mg) as subcutaneous (SC) injection at Week 0 followed by golimumab 100 mg as SC injection at Weeks 2, 6, 10, 14, 18, 22, 26, 30 and 34. Participants received placebo as intravenous (IV) infusion as Weeks 0, 4, 8 and as SC injection at Weeks 16, 24, 32 to maintain the blind. Participants were then followed up for safety from Week 38 to Week 50 (end of study \[EOS\]).
|
Guselkumab Monotherapy
n=71 Participants
Participants received guselkumab 200 mg as IV infusion at Weeks 0, 4 and 8 followed by guselkumab 100 mg as SC injection at Weeks 16, 24 and 32. Participants received placebo as SC injection at Weeks 0, 2, 6, 10, 14, 18, 22, 26, 30, and 34 to maintain the blind. Participants were then followed up for safety from Week 38 to Week 50 (EOS).
|
Combination Therapy
n=71 Participants
Participants received guselkumab 200 mg as IV infusion followed by golimumab 200 mg as SC injection at Weeks 0. Participants received guselkumab 200 mg as IV infusion at Weeks 4 and 8, golimumab 100 mg as SC injection at Weeks 2, 6 and 10 and placebo as SC injection at Weeks 14, 18, 22, 26, 30, and 34 to maintain the blind. Participants were then followed up for safety from Week 38 to Week 50 (EOS).
|
Total
n=214 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
72 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
213 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Continuous
|
38.1 years
STANDARD_DEVIATION 10.47 • n=5 Participants
|
39.1 years
STANDARD_DEVIATION 13.67 • n=7 Participants
|
37.8 years
STANDARD_DEVIATION 11.69 • n=5 Participants
|
38.4 years
STANDARD_DEVIATION 11.96 • n=4 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
199 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
67 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
208 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
ARGENTINA
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
AUSTRALIA
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
BRAZIL
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Region of Enrollment
GERMANY
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
MEXICO
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
POLAND
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Region of Enrollment
RUSSIAN FEDERATION
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Region of Enrollment
UKRAINE
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Region of Enrollment
UNITED STATES
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Efficacy analyses were based on the full analysis set (FAS), which included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
Clinical response was defined as a decrease from baseline in the Mayo score greater than or equal to (\>=) 30 percent (%) and \>=3 points with either a decrease from baseline in the rectal bleeding subscore (RBS) \>=1 or a RBS of 0 or 1. The Mayo score was calculated as the sum of 4 subscores (stool frequency, rectal bleeding, physician's global assessment, and endoscopy findings - each with score range of 0 (normal activity) to 3 (severe activity) and a total score range of 0 to 12 points. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease. Higher scores indicate more severity. This outcome measure was analyzed for combination phase only as preplanned in the protocol.
Outcome measures
| Measure |
Combination Phase: Golimumab Monotherapy
n=72 Participants
Participants received golimumab 200 milligrams (mg) as subcutaneous (SC) injection at Week 0, followed by golimumab 100 mg as SC injection at Weeks 2, 6 and 10. Participants received placebo as intravenous (IV) infusion at Weeks 0, 4 and 8 to maintain the blind. Participants were then assessed for efficacy at Week 10 and Week 12.
|
Combination Phase: Guselkumab Monotherapy
n=71 Participants
Participants received guselkumab 200 mg as IV infusion at Weeks 0, 4 and 8. Participants received placebo as SC injection at Weeks 0, 2, 6 and 10 to maintain the blind. Participants were then assessed for efficacy at Week 10 and Week 12.
|
Combination Phase: Combination Therapy
n=71 Participants
Participants received guselkumab 200 mg as IV infusion at Weeks 0, 4, and 8. Participants received golimumab 200 mg as SC injection at Week 0, followed by golimumab 100 mg as SC injection at Weeks 2, 6 and 10. Participants were then assessed for efficacy at Week 10 and Week 12.
|
|---|---|---|---|
|
Combination Phase: Percentage of Participants Who Achieved Clinical Response at Week 12
|
61.1 Percentage of participants
|
74.6 Percentage of participants
|
83.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Efficacy analyses were based on the FAS, which included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
Clinical remission was defined as the Mayo score less than or equal to (\<=) 2 with no individual subscore greater than (\>) 1. The Mayo score was calculated as the sum of 4 subscores (stool frequency, rectal bleeding, physician's global assessment, and endoscopy findings) each with score range of 0 (normal activity) to 3 (severe activity) and a total score range of 0 to 12 points. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease. Higher scores indicate more severity. This outcome measure was analyzed for combination phase only as preplanned in the protocol.
Outcome measures
| Measure |
Combination Phase: Golimumab Monotherapy
n=72 Participants
Participants received golimumab 200 milligrams (mg) as subcutaneous (SC) injection at Week 0, followed by golimumab 100 mg as SC injection at Weeks 2, 6 and 10. Participants received placebo as intravenous (IV) infusion at Weeks 0, 4 and 8 to maintain the blind. Participants were then assessed for efficacy at Week 10 and Week 12.
|
Combination Phase: Guselkumab Monotherapy
n=71 Participants
Participants received guselkumab 200 mg as IV infusion at Weeks 0, 4 and 8. Participants received placebo as SC injection at Weeks 0, 2, 6 and 10 to maintain the blind. Participants were then assessed for efficacy at Week 10 and Week 12.
|
Combination Phase: Combination Therapy
n=71 Participants
Participants received guselkumab 200 mg as IV infusion at Weeks 0, 4, and 8. Participants received golimumab 200 mg as SC injection at Week 0, followed by golimumab 100 mg as SC injection at Weeks 2, 6 and 10. Participants were then assessed for efficacy at Week 10 and Week 12.
|
|---|---|---|---|
|
Combination Phase: Percentage of Participants Who Achieved Clinical Remission at Week 12
|
22.2 Percentage of participants
|
21.1 Percentage of participants
|
36.6 Percentage of participants
|
Adverse Events
Combination Phase: Golimumab Monotherapy
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Combination Phase: Guselkumab Monotherapy
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Combination Phase: Combination Therapy
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Monotherapy Phase: Golimumab Monotherapy
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Monotherapy Phase: Guselkumab Monotherapy
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Monotherapy Phase: Combination Therapy
Serious events: 3 serious events
Other events: 14 other events
Deaths: 1 deaths
Safety Follow-up: Golimumab Monotherapy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Safety Follow-up: Guselkumab Monotherapy
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
Safety Follow-up: Combination Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Combination Phase: Golimumab Monotherapy
n=72 participants at risk
Participants received golimumab 200 milligrams (mg) as subcutaneous (SC) injection at Week 0, followed by golimumab 100 mg as SC injection at Weeks 2, 6 and 10. Participants received placebo as intravenous (IV) infusion at Weeks 0, 4 and 8 to maintain the blind. Participants were then assessed for efficacy at Week 10 and Week 12.
|
Combination Phase: Guselkumab Monotherapy
n=71 participants at risk
Participants received guselkumab 200 mg as IV infusion at Weeks 0, 4 and 8. Participants received placebo as SC injection at Weeks 0, 2, 6 and 10 to maintain the blind. Participants were then assessed for efficacy at Week 10 and Week 12.
|
Combination Phase: Combination Therapy
n=71 participants at risk
Participants received guselkumab 200 mg as IV infusion at Weeks 0, 4, and 8. Participants received golimumab 200 mg as SC injection at Week 0, followed by golimumab 100 mg as SC injection at Weeks 2, 6 and 10. Participants were then assessed for efficacy at Week 10 and Week 12.
|
Monotherapy Phase: Golimumab Monotherapy
n=67 participants at risk
Participants received golimumab 100 mg as SC injection at Weeks 14, 18, 22, 26, 30 and 34, and placebo as SC injection at Weeks 16, 24, and 32 to maintain the blind. Participants were then assessed for efficacy at Week 38.
|
Monotherapy Phase: Guselkumab Monotherapy
n=70 participants at risk
Participants received guselkumab 100 mg as SC injection at Weeks 16, 24, and 32, and placebo as SC injection at Weeks 14, 18, 22, 26, 30, and 34 to maintain the blind. Participants were then assessed for efficacy at Week 38.
|
Monotherapy Phase: Combination Therapy
n=71 participants at risk
Participants received guselkumab 100 mg as SC injection at Weeks 16, 24 and 32, and placebo as SC injection at Weeks 14, 18, 22, 26, 30, and 34 to maintain the blind. Participants were then assessed for efficacy at Week 38.
|
Safety Follow-up: Golimumab Monotherapy
n=58 participants at risk
Participants were followed up for safety from Week 38 to Week 50 (end of study \[EOS\]) and did not receive any additional medication in the safety follow-up phase.
|
Safety Follow-up: Guselkumab Monotherapy
n=65 participants at risk
Participants were followed up for safety from Week 38 to Week 50 (EOS) and did not receive any additional medication in the safety follow-up phase.
|
Safety Follow-up: Combination Therapy
n=60 participants at risk
Participants were followed up for safety from Week 38 to Week 50 (EOS) and did not receive any additional medication in the safety follow-up phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/72 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
1.4%
1/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/67 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/70 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/58 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/65 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/60 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
1.4%
1/72 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/67 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/70 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/58 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/65 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/60 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/72 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/67 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/70 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/58 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
1.5%
1/65 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/60 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/72 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
1.4%
1/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/67 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/70 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/58 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/65 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/60 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/72 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/67 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
1.4%
1/70 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/58 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/65 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/60 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
|
Infections and infestations
Chronic Sinusitis
|
0.00%
0/72 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
1.5%
1/67 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/70 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/58 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/65 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/60 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
|
Infections and infestations
Covid-19
|
0.00%
0/72 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/67 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/70 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/58 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
1.5%
1/65 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/60 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
|
Infections and infestations
Covid-19 Pneumonia
|
0.00%
0/72 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
1.5%
1/67 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/70 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/58 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/65 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/60 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
|
Infections and infestations
Influenza
|
0.00%
0/72 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
1.4%
1/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/67 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/70 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/58 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/65 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/60 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
|
Infections and infestations
Sepsis
|
0.00%
0/72 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
1.4%
1/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/67 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/70 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/58 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/65 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/60 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
|
Infections and infestations
Tuberculosis of Intrathoracic Lymph Nodes
|
0.00%
0/72 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/67 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/70 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
1.4%
1/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/58 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/65 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/60 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.00%
0/72 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/67 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/70 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
1.4%
1/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/58 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/65 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/60 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/72 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/67 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/70 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
1.4%
1/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/58 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/65 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/60 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of Colon
|
0.00%
0/72 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/67 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/70 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/58 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
1.5%
1/65 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/60 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/72 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
1.5%
1/67 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/70 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
1.4%
1/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/58 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/65 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/60 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
Other adverse events
| Measure |
Combination Phase: Golimumab Monotherapy
n=72 participants at risk
Participants received golimumab 200 milligrams (mg) as subcutaneous (SC) injection at Week 0, followed by golimumab 100 mg as SC injection at Weeks 2, 6 and 10. Participants received placebo as intravenous (IV) infusion at Weeks 0, 4 and 8 to maintain the blind. Participants were then assessed for efficacy at Week 10 and Week 12.
|
Combination Phase: Guselkumab Monotherapy
n=71 participants at risk
Participants received guselkumab 200 mg as IV infusion at Weeks 0, 4 and 8. Participants received placebo as SC injection at Weeks 0, 2, 6 and 10 to maintain the blind. Participants were then assessed for efficacy at Week 10 and Week 12.
|
Combination Phase: Combination Therapy
n=71 participants at risk
Participants received guselkumab 200 mg as IV infusion at Weeks 0, 4, and 8. Participants received golimumab 200 mg as SC injection at Week 0, followed by golimumab 100 mg as SC injection at Weeks 2, 6 and 10. Participants were then assessed for efficacy at Week 10 and Week 12.
|
Monotherapy Phase: Golimumab Monotherapy
n=67 participants at risk
Participants received golimumab 100 mg as SC injection at Weeks 14, 18, 22, 26, 30 and 34, and placebo as SC injection at Weeks 16, 24, and 32 to maintain the blind. Participants were then assessed for efficacy at Week 38.
|
Monotherapy Phase: Guselkumab Monotherapy
n=70 participants at risk
Participants received guselkumab 100 mg as SC injection at Weeks 16, 24, and 32, and placebo as SC injection at Weeks 14, 18, 22, 26, 30, and 34 to maintain the blind. Participants were then assessed for efficacy at Week 38.
|
Monotherapy Phase: Combination Therapy
n=71 participants at risk
Participants received guselkumab 100 mg as SC injection at Weeks 16, 24 and 32, and placebo as SC injection at Weeks 14, 18, 22, 26, 30, and 34 to maintain the blind. Participants were then assessed for efficacy at Week 38.
|
Safety Follow-up: Golimumab Monotherapy
n=58 participants at risk
Participants were followed up for safety from Week 38 to Week 50 (end of study \[EOS\]) and did not receive any additional medication in the safety follow-up phase.
|
Safety Follow-up: Guselkumab Monotherapy
n=65 participants at risk
Participants were followed up for safety from Week 38 to Week 50 (EOS) and did not receive any additional medication in the safety follow-up phase.
|
Safety Follow-up: Combination Therapy
n=60 participants at risk
Participants were followed up for safety from Week 38 to Week 50 (EOS) and did not receive any additional medication in the safety follow-up phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.9%
5/72 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
8.5%
6/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
5.6%
4/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
3.0%
2/67 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
8.6%
6/70 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/58 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
1.5%
1/65 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/60 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.8%
2/72 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
5.6%
4/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
2.8%
2/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
1.5%
1/67 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
2.9%
2/70 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
2.8%
2/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/58 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/65 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/60 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
11.1%
8/72 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
1.4%
1/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
5.6%
4/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
7.5%
5/67 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
5.7%
4/70 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
8.5%
6/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
5.2%
3/58 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
1.5%
1/65 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/60 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.6%
4/72 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
7.0%
5/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
1.4%
1/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
3.0%
2/67 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
2.9%
2/70 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
8.5%
6/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/58 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/65 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/60 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
|
Nervous system disorders
Headache
|
2.8%
2/72 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
4.2%
3/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
5.6%
4/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
3.0%
2/67 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
7.1%
5/70 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
4.2%
3/71 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/58 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/65 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
0.00%
0/60 • Up to Week 50
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
|
Additional Information
Head of Gastroenterology Clinical Development
Janssen Research & Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, 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.
- Publication restrictions are in place
Restriction type: OTHER