Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (NCT NCT03596645)

Last Updated: 2025-11-14

Results Overview

Percentage of participants with clinical remission at Week 6 as assessed by the Mayo score was reported. Clinical remission was defined as a Mayo score of less than or equal to (\<=) 2 point, with no individual sub-score greater than (\>) 1. The Mayo score was sum of 4 sub-scores (that is, stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total score was calculated as the sum of the 4 sub scores and values ranged from 0 to 12. A score of 3 to 5 points indicated mildly active disease; a score of 6 to 10 indicated moderately active disease; and a score of 11 to 12 indicated severe disease.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

84 participants

Primary outcome timeframe

Week 6

Results posted on

2025-11-14

Participant Flow

Results are currently reported until the primary completion date (21-Nov-2023). Final results will be posted upon study completion.

Participant milestones

Participant milestones
Measure	Group 1: Golimumab In short term phase (Week 0-6), participants weighing greater than or equal to (\>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (\<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m\^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m\^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m\^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m\^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor.	Group 2: Infliximab In short term phase (Week 0-6), participants weighing \>=30 kg, received infliximab 5 mg/kg intravenous (IV) infusion at Week 0 and Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued to receive infliximab 5 mg/kg IV infusion every 8 weeks (q8w) through Week 46. Participants who did not show a clinical response at Week 6 received an increased dose of infliximab that is 10 mg/kg (capped at 1 gram) starting at Week 6 and every q8q thereafter, or 5 mg/kg at Week 6 and Week 8 followed by 10 mg/kg (capped at 1 gram) at Week 14 and every q8w thereafter. Participants who showed a partial Mayo responders at Week 14 continued infliximab 10 mg/kg every 8 weeks through Week 46. Participants who did not show partial Mayo response at Week 14 either received a further dose escalation to 10 mg/kg q4w (capped at 1 gram) or were withdrawn from the study. At Week 22, participants who received the escalated dose of infliximab 10 mg/kg q4w were required to show a partial Mayo response and who met this criterion continued to receive open-label infliximab 10 mg/kg (capped at 1 gram) q4w through Week 50. After Week 54 evaluations, participants receiving infliximab were withdrawn from study participation and transitioned to local standard of care.
Overall Study STARTED	69	15
Overall Study Treated	69	14
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	69	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: Golimumab In short term phase (Week 0-6), participants weighing greater than or equal to (\>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (\<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m\^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m\^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m\^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m\^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor.	Group 2: Infliximab In short term phase (Week 0-6), participants weighing \>=30 kg, received infliximab 5 mg/kg intravenous (IV) infusion at Week 0 and Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued to receive infliximab 5 mg/kg IV infusion every 8 weeks (q8w) through Week 46. Participants who did not show a clinical response at Week 6 received an increased dose of infliximab that is 10 mg/kg (capped at 1 gram) starting at Week 6 and every q8q thereafter, or 5 mg/kg at Week 6 and Week 8 followed by 10 mg/kg (capped at 1 gram) at Week 14 and every q8w thereafter. Participants who showed a partial Mayo responders at Week 14 continued infliximab 10 mg/kg every 8 weeks through Week 46. Participants who did not show partial Mayo response at Week 14 either received a further dose escalation to 10 mg/kg q4w (capped at 1 gram) or were withdrawn from the study. At Week 22, participants who received the escalated dose of infliximab 10 mg/kg q4w were required to show a partial Mayo response and who met this criterion continued to receive open-label infliximab 10 mg/kg (capped at 1 gram) q4w through Week 50. After Week 54 evaluations, participants receiving infliximab were withdrawn from study participation and transitioned to local standard of care.
Overall Study Adverse Event	17	0
Overall Study Lack of Efficacy	8	0
Overall Study Lost to Follow-up	1	1
Overall Study Physician Decision	1	1
Overall Study Protocol Violation	1	0
Overall Study Initiated Prohibited Medication	1	0
Overall Study Withdrawal by Parent/Guardian	1	0
Overall Study No mucosal healing achieved	1	0
Overall Study Disease progression	1	0
Overall Study Ongoing	37	12
Overall Study Randomized but not treated	0	1

Baseline Characteristics

A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: Golimumab n=69 Participants In short term phase (Week 0-6), participants weighing greater than or equal to (\>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (\<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m\^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m\^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m\^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m\^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor.	Group 2: Infliximab n=14 Participants In short term phase (Week 0-6), participants weighing \>=30 kg, received infliximab 5 mg/kg intravenous (IV) infusion at Week 0 and Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued to receive infliximab 5 mg/kg IV infusion every 8 weeks (q8w) through Week 46. Participants who did not show a clinical response at Week 6 received an increased dose of infliximab that is 10 mg/kg (capped at 1 gram) starting at Week 6 and every q8q thereafter, or 5 mg/kg at Week 6 and Week 8 followed by 10 mg/kg (capped at 1 gram) at Week 14 and every q8w thereafter. Participants who showed a partial Mayo responders at Week 14 continued infliximab 10 mg/kg every 8 weeks through Week 46. Participants who did not show partial Mayo response at Week 14 either received a further dose escalation to 10 mg/kg q4w (capped at 1 gram) or were withdrawn from the study. At Week 22, participants who received the escalated dose of infliximab 10 mg/kg q4w were required to show a partial Mayo response and who met this criterion continued to receive open-label infliximab 10 mg/kg (capped at 1 gram) q4w through Week 50. After Week 54 evaluations, participants receiving infliximab were withdrawn from study participation and transitioned to local standard of care.	Total n=83 Participants Total of all reporting groups
Age, Continuous	13.4 Years STANDARD_DEVIATION 3.3 • n=10 Participants	14.3 Years STANDARD_DEVIATION 2.23 • n=10 Participants	13.6 Years STANDARD_DEVIATION 3.15 • n=20 Participants
Sex: Female, Male Female	37 Participants n=10 Participants	8 Participants n=10 Participants	45 Participants n=20 Participants
Sex: Female, Male Male	32 Participants n=10 Participants	6 Participants n=10 Participants	38 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=10 Participants	0 Participants n=10 Participants	17 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=10 Participants	14 Participants n=10 Participants	64 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=10 Participants	0 Participants n=10 Participants	2 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=10 Participants	0 Participants n=10 Participants	2 Participants n=20 Participants
Race (NIH/OMB) Asian	12 Participants n=10 Participants	5 Participants n=10 Participants	17 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	2 Participants n=10 Participants	0 Participants n=10 Participants	2 Participants n=20 Participants
Race (NIH/OMB) White	50 Participants n=10 Participants	9 Participants n=10 Participants	59 Participants n=20 Participants
Race (NIH/OMB) More than one race	1 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=10 Participants	0 Participants n=10 Participants	2 Participants n=20 Participants
Region of Enrollment Belgium	3 Participants n=10 Participants	0 Participants n=10 Participants	3 Participants n=20 Participants
Region of Enrollment Brazil	11 Participants n=10 Participants	0 Participants n=10 Participants	11 Participants n=20 Participants
Region of Enrollment France	1 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants
Region of Enrollment Israel	10 Participants n=10 Participants	3 Participants n=10 Participants	13 Participants n=20 Participants
Region of Enrollment Italy	9 Participants n=10 Participants	2 Participants n=10 Participants	11 Participants n=20 Participants
Region of Enrollment Poland	16 Participants n=10 Participants	3 Participants n=10 Participants	19 Participants n=20 Participants
Region of Enrollment Korea, South	12 Participants n=10 Participants	5 Participants n=10 Participants	17 Participants n=20 Participants
Region of Enrollment Spain	3 Participants n=10 Participants	0 Participants n=10 Participants	3 Participants n=20 Participants
Region of Enrollment United States	4 Participants n=10 Participants	1 Participants n=10 Participants	5 Participants n=20 Participants
Age Categorical 2-5 years	2 Participants n=10 Participants	0 Participants n=10 Participants	2 Participants n=20 Participants
Age Categorical 6-11 years	13 Participants n=10 Participants	2 Participants n=10 Participants	15 Participants n=20 Participants
Age Categorical 12-17 years	54 Participants n=10 Participants	12 Participants n=10 Participants	66 Participants n=20 Participants

PRIMARY outcome

Timeframe: Week 6

Population: FGAS1 included all enrolled participants who received at least 1 dose (complete or partial) of golimumab during the induction phase. This outcome measure was planned to be reported for "Group 1: Golimumab" arm only.

Outcome measures

Outcome measures
Measure	Group 1: Golimumab n=69 Participants In short term phase (Week 0-6), participants weighing greater than or equal to (\>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (\<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m\^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m\^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m\^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m\^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor.
Percentage of Participants With Clinical Remission at Week 6 as Assessed by the Mayo Score	31.9 Percentage of participants Interval 22.7 to 41.1

SECONDARY outcome

Timeframe: Week 54

Population: Full golimumab analysis set 2 (FGAS2) included participants who were in clinical response at Week 6 to golimumab as assessed by the Mayo score (local reader) and who received at least 1 dose (complete or partial) of golimumab during the long-term phase. This outcome measure was planned to be reported for "Group 1: Golimumab" arm only.

Percentage of participants with symptomatic remission at Week 54 was reported. Symptomatic remission was defined as a Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity.

Outcome measures

Outcome measures
Measure	Group 1: Golimumab n=41 Participants In short term phase (Week 0-6), participants weighing greater than or equal to (\>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (\<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m\^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m\^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m\^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m\^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor.
Percentage of Participants With Symptomatic Remission at Week 54	39.0 Percentage of participants Interval 26.5 to 51.6

SECONDARY outcome

Timeframe: Week 54

Population: FGAS2 included participants who were in clinical response at Week 6 to golimumab as assessed by the Mayo score (local reader) and who received at least 1 dose (complete or partial) of golimumab during the long-term phase. This outcome measure was planned to be reported for "Group 1: Golimumab" arm only.

Percentage of participants with clinical remission at Week 54 was reported. Clinical remission was defined as a Mayo score \<= 2 points, with no individual subscore \>1. The Mayo score was the sum of 4 sub-scores (that is, stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total score was calculated as the sum of the 4 sub scores and values ranged from 0 to 12. A score of 3 to 5 points indicated mildly active disease; a score of 6 to 10 indicated moderately active disease; and a score of 11 to 12 indicated severe disease.

Outcome measures

Outcome measures
Measure	Group 1: Golimumab n=41 Participants In short term phase (Week 0-6), participants weighing greater than or equal to (\>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (\<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m\^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m\^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m\^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m\^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor.
Percentage of Participants With Clinical Remission at Week 54 as Assessed by the Mayo Score	31.7 Percentage of participants Interval 19.8 to 43.7

SECONDARY outcome

Timeframe: Week 54

Percentage of participants with clinical remission at Week 54 as assessed by PUCAI score was reported. Clinical remission as measured by the PUCAI score was a PUCAI score \<10. PUCAI score was intended for pediatric participants with UC. PUCAI consisted of the following 6 subscores with scores as: abdominal pain (no pain =0, pain can be ignored =5, pain cannot be ignored =10); rectal bleeding (none =0, small amount only \[in less than 50 percent (%) of stools\] =10, small amount with most stools =20, large amount \[\>50% of the stool content\] =30); stool consistency of most stools (formed =0, partially formed =5, completely unformed =10); number of stools per 24 hours (0-2 =0, 3-5 =5, 6-8 =10, \>8 =15); nocturnal bowel movement (no =0, yes =10); activity level (no limitation of activity =0, occasional limitation of activity =5, severely restricted activity =10). PUCAI score = sum of scores of 6 items; score range of 0= no severity to 85= extreme severity.

Outcome measures

Outcome measures
Measure	Group 1: Golimumab n=41 Participants In short term phase (Week 0-6), participants weighing greater than or equal to (\>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (\<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m\^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m\^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m\^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m\^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor.
Percentage of Participants With Clinical Remission at Week 54 as Assessed by the Pediatric Ulcerative Colitis Activity Index Score (PUCAI) Score	34.1 Percentage of participants Interval 22.0 to 46.3

SECONDARY outcome

Timeframe: Week 6

Population: FGAS1 included all enrolled participants who received at least 1 dose (complete or partial) of golimumab during the Short-Term Phase (Weeks 0-6). This outcome measure was planned to be reported for "Group 1: Golimumab" arm only.

Percentage of participants with clinical remission at Week 6 as assessed by PUCAI score was reported. Clinical remission as measured by the PUCAI score was a PUCAI score \<10. PUCAI score was intended for pediatric participants with UC. PUCAI consisted of the following 6 subscores with scores as: abdominal pain (no pain =0, pain can be ignored =5, pain cannot be ignored =10); rectal bleeding (none =0, small amount only \[in less than 50% of stools\] =10, small amount with most stools =20, large amount \[\>50% of the stool content\] =30); stool consistency of most stools (formed =0, partially formed =5, completely unformed =10); number of stools per 24 hours (0-2 =0, 3-5 =5, 6-8 =10, \>8 =15); nocturnal bowel movement (no =0, yes =10); activity level (no limitation of activity =0, occasional limitation of activity =5, severely restricted activity =10). PUCAI score = sum of scores of 6 items; score range of 0= no severity to 85= extreme severity.

Outcome measures

Outcome measures
Measure	Group 1: Golimumab n=69 Participants In short term phase (Week 0-6), participants weighing greater than or equal to (\>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (\<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m\^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m\^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m\^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m\^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor.
Percentage of Participants With Clinical Remission at Week 6 as Assessed by the Pediatric Ulcerative Colitis Activity Index Score (PUCAI) Score	33.3 Percentage of participants Interval 24.0 to 42.7

SECONDARY outcome

Timeframe: Week 6

Clinical response was defined as a decrease from baseline in the Mayo score by \>= 30% and \>= 3 points, with either a decrease from baseline in the rectal bleeding subscore of \>= 1 or a rectal bleeding subscore of 0 or 1. The Mayo score was the sum of 4 sub-scores (that is, stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total score was calculated as the sum of the 4 sub scores and values ranged from 0 to 12. A score of 3 to 5 points indicated mildly active disease; a score of 6 to 10 indicated moderately active disease; and a score of 11 to 12 indicated severe disease.

Outcome measures

Outcome measures
Measure	Group 1: Golimumab n=69 Participants In short term phase (Week 0-6), participants weighing greater than or equal to (\>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (\<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m\^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m\^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m\^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m\^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor.
Percentage of Participants With Clinical Response at Week 6 as Assessed by the Mayo Score	56.5 Percentage of participants Interval 46.7 to 66.3

SECONDARY outcome

Timeframe: Week 6

Percentage of participants with endoscopic healing at Week 6 as assessed by the Mayo score was reported. Endoscopic healing was defined by an endoscopy subscore of the Mayo score of 0 or 1 based on local endoscopy. The Mayo score was the sum of 4 sub-scores (that is, stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each subscore rated on a scale from 0 (normal) to 3 (severe), with higher scores indicating more severe disease. The total score was calculated as the sum of the 4 sub scores and values ranged from 0 to 12. A score of 3 to 5 points indicated mildly active disease; a score of 6 to 10 indicated moderately active disease; and a score of 11 to 12 indicated severe disease.

Outcome measures

Outcome measures
Measure	Group 1: Golimumab n=69 Participants In short term phase (Week 0-6), participants weighing greater than or equal to (\>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (\<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m\^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m\^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m\^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m\^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor.
Percentage of Participants With Endoscopic Healing at Week 6 as Assessed by the Mayo Score	40.6 Percentage of participants Interval 30.9 to 50.3

SECONDARY outcome

Timeframe: Week 54

Percentage of participants with endoscopic healing at Week 54 as assessed by the Mayo score was reported. Endoscopic healing is defined as an endoscopy subscore of the Mayo score of 0 or 1 based on local endoscopy. The Mayo score was the sum of 4 sub-scores (that is, stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each subscore rated on a scale from 0 (normal) to 3 (severe), with higher scores indicating more severe disease. The total score was calculated as the sum of the 4 sub scores and values ranged from 0 to 12. A score of 3 to 5 points indicated mildly active disease; a score of 6 to 10 indicated moderately active disease; and a score of 11 to 12 indicated severe disease.

Outcome measures

Outcome measures
Measure	Group 1: Golimumab n=41 Participants In short term phase (Week 0-6), participants weighing greater than or equal to (\>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (\<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m\^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m\^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m\^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m\^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor.
Percentage of Participants With Endoscopic Healing at Week 54 as Assessed by the Mayo Score	36.6 Percentage of participants Interval 24.2 to 49.0

SECONDARY outcome

Timeframe: Week 54

Population: Analysis population included participants who had achieved clinical remission at Week 6. This outcome measure was planned to be reported for "Group 1: Golimumab" arm only.

Percentage of participants with clinical remission at Week 54 as assessed by the Mayo score for participants who were in clinical remission at week 6 was reported. Clinical remission was defined as a Mayo score \<=2 points, with no individual subscore \>1. The Mayo score was the sum of 4 sub-scores (that is, stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total score was calculated as the sum of the 4 sub scores and values ranged from 0 to 12. A score of 3 to 5 points indicated mildly active disease; a score of 6 to 10 indicated moderately active disease; and a score of 11 to 12 indicated severe disease.

Outcome measures

Outcome measures
Measure	Group 1: Golimumab n=22 Participants In short term phase (Week 0-6), participants weighing greater than or equal to (\>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (\<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m\^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m\^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m\^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m\^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor.
Percentage of Participants With Clinical Remission at Week 54 as Assessed by the Mayo Score for Participants Who Were in Clinical Remission at Week 6	54.5 Percentage of participants Interval 37.1 to 72.0

SECONDARY outcome

Timeframe: Week 54

Percentage of participants who were not receiving corticosteroids for at least 12 weeks prior to Week 54 and in clinical remission at week 54 was reported. Clinical remission was defined as a Mayo score \<=2 points, with no individual subscore \>1. The Mayo score was the sum of 4 sub-scores (that is, stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total score was calculated as the sum of the 4 sub scores and values ranged from 0 to 12. A score of 3 to 5 points indicated mildly active disease; a score of 6 to 10 indicated moderately active disease; and a score of 11 to 12 indicated severe disease.

Outcome measures

Outcome measures
Measure	Group 1: Golimumab n=41 Participants In short term phase (Week 0-6), participants weighing greater than or equal to (\>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (\<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m\^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m\^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m\^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m\^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor.
Percentage of Participants Who Were Not Receiving Corticosteroids for at Least 12 Weeks Prior to Week 54 and in Clinical Remission at Week 54	31.7 Percentage of participants Interval 19.8 to 43.7

Adverse Events

Group 1: Golimumab

Serious events: 28 serious events

Other events: 62 other events

Deaths: 0 deaths

Group 2: Infliximab

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

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 to allow for filing of a patent application.
Publication restrictions are in place

Restriction type: OTHER

Measure	Group 1: Golimumab n=69 participants at risk In short term phase (Week 0-6), participants weighing greater than or equal to (\>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (\<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m\^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m\^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m\^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m\^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor.	Group 2: Infliximab n=14 participants at risk In short term phase (Week 0-6), participants weighing \>=30 kg, received infliximab 5 mg/kg intravenous (IV) infusion at Week 0 and Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued to receive infliximab 5 mg/kg IV infusion every 8 weeks (q8w) through Week 46. Participants who did not show a clinical response at Week 6 received an increased dose of infliximab that is 10 mg/kg (capped at 1 gram) starting at Week 6 and every q8q thereafter, or 5 mg/kg at Week 6 and Week 8 followed by 10 mg/kg (capped at 1 gram) at Week 14 and every q8w thereafter. Participants who showed a partial Mayo responders at Week 14 continued infliximab 10 mg/kg every 8 weeks through Week 46. Participants who did not show partial Mayo response at Week 14 either received a further dose escalation to 10 mg/kg q4w (capped at 1 gram) or were withdrawn from the study. At Week 22, participants who received the escalated dose of infliximab 10 mg/kg q4w were required to show a partial Mayo response and who met this criterion continued to receive open-label infliximab 10 mg/kg (capped at 1 gram) q4w through Week 50. After Week 54 evaluations, participants receiving infliximab were withdrawn from study participation and transitioned to local standard of care.
Blood and lymphatic system disorders Anaemia	1.4% 1/69 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.	0.00% 0/14 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.
Gastrointestinal disorders Abdominal Pain	1.4% 1/69 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.	0.00% 0/14 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.
Gastrointestinal disorders Colitis	1.4% 1/69 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.	0.00% 0/14 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.
Gastrointestinal disorders Colitis Ulcerative	24.6% 17/69 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.	0.00% 0/14 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.
Gastrointestinal disorders Pancreatitis	0.00% 0/69 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.	7.1% 1/14 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.
Infections and infestations Clostridium Difficile Infection	1.4% 1/69 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.	0.00% 0/14 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.
Infections and infestations Covid-19	1.4% 1/69 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.	0.00% 0/14 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.
Infections and infestations Cytomegalovirus Colitis	2.9% 2/69 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.	0.00% 0/14 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.
Infections and infestations Cytomegalovirus Infection	0.00% 0/69 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.	7.1% 1/14 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.
Infections and infestations Pneumonia	2.9% 2/69 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.	0.00% 0/14 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.
Infections and infestations Pseudomembranous Colitis	1.4% 1/69 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.	0.00% 0/14 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.
Infections and infestations Stump Appendicitis	1.4% 1/69 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.	0.00% 0/14 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.
Injury, poisoning and procedural complications Hand Fracture	1.4% 1/69 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.	0.00% 0/14 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.
Investigations Fungal Test Positive	1.4% 1/69 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.	0.00% 0/14 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.
Musculoskeletal and connective tissue disorders Sacroiliitis	1.4% 1/69 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.	0.00% 0/14 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.
Reproductive system and breast disorders Breast Mass	1.4% 1/69 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.	0.00% 0/14 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.4% 1/69 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.	0.00% 0/14 • All cause mortality: From screening (-6 weeks) up to Week 70; serious adverse events (SAEs) and other adverse events (AEs): From baseline (Day 1) up to Week 70 (Group 1: Golimumab) arm: Safety Golimumab analysis set included all enrolled participants who received at least 1 dose (complete or partial) of golimumab. (Group 2: Infliximab arm): Safety Infliximab analysis set includes all enrolled participants who received at least 1 dose (complete or partial) of infliximab.