Trial Outcomes & Findings for A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS) (NCT NCT01230827)
NCT ID: NCT01230827
Last Updated: 2016-04-04
Results Overview
Percentage of participants with American College of Rheumatology (ACR) Ped 30 responders at Week 16 who did not experience a flare of disease between Week 16 and Week 48 calculated as number of participants with response and who did not experience flare divided by number of participants randomized. Flare of disease was defined as the worsening from Week 16 by 30% or more in 3 of the 6 ACR Pediatric (Ped) Core Set Variables with no more than 1 of the 6 ACR Ped Core Set variables improving by more than 30% at the time of the flare. The 6 variables are: physicians global assessment of disease, participants/parent global assessment of overall well-being, number of active joints (defined as either swelling, or in absence of swelling, limited range of motion associated with pain on motion or tenderness), number of joints with limited range of motion, physical function by childhood health assessment questionnaire, and erythrocyte sedimentation rate.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
173 participants
Primary outcome timeframe
Week 16 through Week 48
Results posted on
2016-04-04
Participant Flow
Participant milestones
| Measure |
Group I: Participants Who Did Not Enter RW Period
Enrolled participants who did not enter randomized withdrawal (RW) period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an American College of Rheumatology \[ACR\] Ped 30 response) at Week 16.
|
Group II: Placebo Subcutaneously (SC) + MTX
Participants who were treated with golimumab 30 milligram per square meter (mg/m\^2) through Week 12 and were treated with placebo + Methotrexate (MTX) at Week 16 and continued on placebo + MTX through Week 48.
|
Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX
Participants who were treated with golimumab 30 mg/m\^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m\^2 + MTX at anytime during the study through Week 48. Adverse events are reported for participants who switched to golimumab 30 mg/m\^2 + MTX at anytime during the study through Week 48.
|
Group IV: Golimumab + MTX
Participants were treated with golimumab 30 mg/m\^2 through Week 12 and who were treated with golimumab 30 mg/m\^2 + MTX at Week 16 and continued on golimumab 30 mg/m\^2 + MTX through Week 48.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
11
|
65
|
78
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
19
|
11
|
65
|
78
|
Reasons for withdrawal
| Measure |
Group I: Participants Who Did Not Enter RW Period
Enrolled participants who did not enter randomized withdrawal (RW) period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an American College of Rheumatology \[ACR\] Ped 30 response) at Week 16.
|
Group II: Placebo Subcutaneously (SC) + MTX
Participants who were treated with golimumab 30 milligram per square meter (mg/m\^2) through Week 12 and were treated with placebo + Methotrexate (MTX) at Week 16 and continued on placebo + MTX through Week 48.
|
Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX
Participants who were treated with golimumab 30 mg/m\^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m\^2 + MTX at anytime during the study through Week 48. Adverse events are reported for participants who switched to golimumab 30 mg/m\^2 + MTX at anytime during the study through Week 48.
|
Group IV: Golimumab + MTX
Participants were treated with golimumab 30 mg/m\^2 through Week 12 and who were treated with golimumab 30 mg/m\^2 + MTX at Week 16 and continued on golimumab 30 mg/m\^2 + MTX through Week 48.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
3
|
2
|
|
Overall Study
Lack of Efficacy
|
14
|
1
|
2
|
3
|
|
Overall Study
Adverse Event
|
4
|
2
|
3
|
7
|
|
Overall Study
Recovery
|
0
|
6
|
0
|
0
|
|
Overall Study
Study terminated by Sponsor
|
0
|
2
|
56
|
63
|
Baseline Characteristics
A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)
Baseline characteristics by cohort
| Measure |
Group I: Participants Who Did Not Enter RW Period
n=19 Participants
Enrolled participants who did not enter randomized withdrawal (RW) period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an American College of Rheumatology \[ACR\] Ped 30 response) at Week 16.
|
Group II: Placebo Subcutaneously (SC) + MTX
n=11 Participants
Participants who were treated with golimumab 30 milligram per square meter (mg/m\^2) through Week 12 and were treated with placebo + Methotrexate (MTX) at Week 16 and continued on placebo + MTX through Week 48.
|
Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX
n=65 Participants
Participants who were treated with golimumab 30 mg/m\^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m\^2 + MTX at anytime during the study through Week 48. Adverse events are reported for participants who switched to golimumab 30 mg/m\^2 + MTX at anytime during the study through Week 48.
|
Group IV: Golimumab + MTX
n=78 Participants
Participants were treated with golimumab 30 mg/m\^2 through Week 12 and who were treated with golimumab 30 mg/m\^2 + MTX at Week 16 and continued on golimumab 30 mg/m\^2 + MTX through Week 48.
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
11.8 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
13.6 years
STANDARD_DEVIATION 2.2 • n=7 Participants
|
10.7 years
STANDARD_DEVIATION 4.66 • n=5 Participants
|
11.1 years
STANDARD_DEVIATION 4.43 • n=4 Participants
|
11.2 years
STANDARD_DEVIATION 4.44 • n=21 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
131 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Region of Enrollment
Austria
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Region of Enrollment
Belgium
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
2 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Region of Enrollment
Brazil
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
8 participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
5 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Region of Enrollment
Finland
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
24 participants
n=4 Participants
|
49 participants
n=21 Participants
|
|
Region of Enrollment
Lithuania
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
6 participants
n=5 Participants
|
4 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Region of Enrollment
Mexico
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
8 participants
n=5 Participants
|
11 participants
n=4 Participants
|
22 participants
n=21 Participants
|
|
Region of Enrollment
Netherlands
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Region of Enrollment
Russian Federation
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
12 participants
n=5 Participants
|
12 participants
n=4 Participants
|
29 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
12 participants
n=5 Participants
|
7 participants
n=4 Participants
|
21 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 16 through Week 48Population: Intent-to-treat (ITT) population included all participants achieving American College of Rheumatology (ACR) Pediatric (Ped) 30 response who were randomized at Week 16.
Percentage of participants with American College of Rheumatology (ACR) Ped 30 responders at Week 16 who did not experience a flare of disease between Week 16 and Week 48 calculated as number of participants with response and who did not experience flare divided by number of participants randomized. Flare of disease was defined as the worsening from Week 16 by 30% or more in 3 of the 6 ACR Pediatric (Ped) Core Set Variables with no more than 1 of the 6 ACR Ped Core Set variables improving by more than 30% at the time of the flare. The 6 variables are: physicians global assessment of disease, participants/parent global assessment of overall well-being, number of active joints (defined as either swelling, or in absence of swelling, limited range of motion associated with pain on motion or tenderness), number of joints with limited range of motion, physical function by childhood health assessment questionnaire, and erythrocyte sedimentation rate.
Outcome measures
| Measure |
Placebo
n=76 Participants
Participants received golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Participants who had a clinical response to golimumab at Week 16 and were randomly allocated to placebo, received placebo every 4 weeks through Week 48. However, participants receiving placebo and had flare received golimumab 30 mg/m\^2 every 4 weeks through Week 48. At Week 48, participants who were receiving placebo not having a clinical remission switched to receive golimumab 30 mg/m\^2 in a long-term extension until Week 248 and participants who were receiving placebo and had a clinical remission discontinued from the study. All participants received their fixed dose of commercial methotrexate throughout the study duration.
|
CNTO 148 (Golimumab)
n=78 Participants
Participants received golimumab 30 milligram per square meter (mg/m\^2) every 4 weeks from Week 0 through Week 12. Participants who had a clinical response at Week 16 and who were randomly allocated to golimumab, received 30 mg/m\^2 every 4 weeks through Week 48. Participants continued receiving golimumab 30 mg/m\^2 after Week 48 in a long-term extension until Week 248. All participants received their fixed dose of commercial methotrexate throughout the study duration.
|
|---|---|---|
|
Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 16 Who Did Not Experienced a Flare of Disease Through Week 48
|
52.6 Percentage of Participants
|
59.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 16 through Week 48Population: Intent-to-treat (ITT) population included all participants achieving American College of Rheumatology (ACR) Pediatric (Ped) 30 response who were randomized at Week 16.
Percentage of participants with ACR 30 response at Week 48 was calculated as number of participants with ACR 30 response at Week 48 divided by number of participants randomized. ACR Ped 30 response was defined as the worsening from Week 16 by 30% or more in 3 of the 6 ACR Pediatric (Ped) Core Set Variables with no more than 1 of the 6 ACR Ped Core Set variables improving by more than 30% at the time of the flare. The 6 variables are: physicians global assessment of disease, participants/parent global assessment of overall well-being, number of active joints (defined as either swelling, or in absence of swelling, limited range of motion associated with pain on motion or tenderness), number of joints with limited range of motion, physical function by childhood health assessment questionnaire, and erythrocyte sedimentation rate.
Outcome measures
| Measure |
Placebo
n=76 Participants
Participants received golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Participants who had a clinical response to golimumab at Week 16 and were randomly allocated to placebo, received placebo every 4 weeks through Week 48. However, participants receiving placebo and had flare received golimumab 30 mg/m\^2 every 4 weeks through Week 48. At Week 48, participants who were receiving placebo not having a clinical remission switched to receive golimumab 30 mg/m\^2 in a long-term extension until Week 248 and participants who were receiving placebo and had a clinical remission discontinued from the study. All participants received their fixed dose of commercial methotrexate throughout the study duration.
|
CNTO 148 (Golimumab)
n=78 Participants
Participants received golimumab 30 milligram per square meter (mg/m\^2) every 4 weeks from Week 0 through Week 12. Participants who had a clinical response at Week 16 and who were randomly allocated to golimumab, received 30 mg/m\^2 every 4 weeks through Week 48. Participants continued receiving golimumab 30 mg/m\^2 after Week 48 in a long-term extension until Week 248. All participants received their fixed dose of commercial methotrexate throughout the study duration.
|
|---|---|---|
|
Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 48
|
55.3 Percentage of Participants
|
52.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 16 through Week 48Population: ITT population included all participants achieving ACR Ped 30 response who were randomized at Week 16.
Inactive disease is indicated by the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to juvenile idiopathic arthritis; no active uveitis (eye disease), normal erythrocyte sedimentation rate or C-reactive protein; physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes.
Outcome measures
| Measure |
Placebo
n=76 Participants
Participants received golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Participants who had a clinical response to golimumab at Week 16 and were randomly allocated to placebo, received placebo every 4 weeks through Week 48. However, participants receiving placebo and had flare received golimumab 30 mg/m\^2 every 4 weeks through Week 48. At Week 48, participants who were receiving placebo not having a clinical remission switched to receive golimumab 30 mg/m\^2 in a long-term extension until Week 248 and participants who were receiving placebo and had a clinical remission discontinued from the study. All participants received their fixed dose of commercial methotrexate throughout the study duration.
|
CNTO 148 (Golimumab)
n=78 Participants
Participants received golimumab 30 milligram per square meter (mg/m\^2) every 4 weeks from Week 0 through Week 12. Participants who had a clinical response at Week 16 and who were randomly allocated to golimumab, received 30 mg/m\^2 every 4 weeks through Week 48. Participants continued receiving golimumab 30 mg/m\^2 after Week 48 in a long-term extension until Week 248. All participants received their fixed dose of commercial methotrexate throughout the study duration.
|
|---|---|---|
|
Percentage of Participants With American College of Rheumatology (ACR) 30 Response Who Had Inactive Disease at Week 48
|
27.6 Percentage of Participants
|
39.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 16 through Week 48Population: ITT population included all participants achieving ACR Ped 30 response who were randomized at Week 16.
Clinical remission while on medication for JIA is defined as inactive disease at each visit for a period of 6 months or more while on medication. Inactive disease is indicated by the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to juvenile idiopathic arthritis; no active uveitis (eye disease), normal erythrocyte sedimentation rate or C-reactive protein; physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes.
Outcome measures
| Measure |
Placebo
n=76 Participants
Participants received golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Participants who had a clinical response to golimumab at Week 16 and were randomly allocated to placebo, received placebo every 4 weeks through Week 48. However, participants receiving placebo and had flare received golimumab 30 mg/m\^2 every 4 weeks through Week 48. At Week 48, participants who were receiving placebo not having a clinical remission switched to receive golimumab 30 mg/m\^2 in a long-term extension until Week 248 and participants who were receiving placebo and had a clinical remission discontinued from the study. All participants received their fixed dose of commercial methotrexate throughout the study duration.
|
CNTO 148 (Golimumab)
n=78 Participants
Participants received golimumab 30 milligram per square meter (mg/m\^2) every 4 weeks from Week 0 through Week 12. Participants who had a clinical response at Week 16 and who were randomly allocated to golimumab, received 30 mg/m\^2 every 4 weeks through Week 48. Participants continued receiving golimumab 30 mg/m\^2 after Week 48 in a long-term extension until Week 248. All participants received their fixed dose of commercial methotrexate throughout the study duration.
|
|---|---|---|
|
Percentage of Participants Who Achieved Clinical Remission While on Medication for Juvenile Idiopathic Arthritis (JIA) at Week 48
|
11.8 Percentage of Participants
|
12.8 Percentage of Participants
|
Adverse Events
Group I: Participants Who Did Not Enter RW Period
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
Group II: Placebo Subcutaneously (SC) + MTX
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX
Serious events: 15 serious events
Other events: 60 other events
Deaths: 0 deaths
Group IV: Golimumab + MTX
Serious events: 18 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group I: Participants Who Did Not Enter RW Period
n=19 participants at risk
Enrolled participants who did not enter randomized withdrawal (RW) period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an American College of Rheumatology \[ACR\] Ped 30 response) at Week 16.
|
Group II: Placebo Subcutaneously (SC) + MTX
n=10 participants at risk
Participants who were treated with golimumab 30 milligram per square meter (mg/m\^2) through Week 12 and were treated with placebo + Methotrexate (MTX) at Week 16 and continued on placebo + MTX through Week 48.
|
Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX
n=66 participants at risk
Participants who were treated with golimumab 30 mg/m\^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m\^2 + MTX at anytime during the study through Week 48. Adverse events are reported for participants who switched to golimumab 30 mg/m\^2 + MTX at anytime during the study through Week 48.
|
Group IV: Golimumab + MTX
n=78 participants at risk
Participants were treated with golimumab 30 mg/m\^2 through Week 12 and who were treated with golimumab 30 mg/m\^2 + MTX at Week 16 and continued on golimumab 30 mg/m\^2 + MTX through Week 48.
|
|---|---|---|---|---|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Blood and lymphatic system disorders
Lymphoid tissue hyperplasia
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Eye disorders
Eye pain
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
General disorders
Influenza like illness
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
General disorders
Pain
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Hepatobiliary disorders
Gallbladder oedema
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Appendiceal abscess
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Cellulitis
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Herpes zoster
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Otitis media
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Pyelonephritis
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Scarlet fever
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Wound infection
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
2.6%
2/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Musculoskeletal and connective tissue disorders
Juvenile idiopathic arthritis
|
10.5%
2/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
9.1%
6/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.3%
8/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Nervous system disorders
Demyelination
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Psychiatric disorders
Depression
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Psychiatric disorders
Somatoform disorder neurologic
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
Other adverse events
| Measure |
Group I: Participants Who Did Not Enter RW Period
n=19 participants at risk
Enrolled participants who did not enter randomized withdrawal (RW) period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an American College of Rheumatology \[ACR\] Ped 30 response) at Week 16.
|
Group II: Placebo Subcutaneously (SC) + MTX
n=10 participants at risk
Participants who were treated with golimumab 30 milligram per square meter (mg/m\^2) through Week 12 and were treated with placebo + Methotrexate (MTX) at Week 16 and continued on placebo + MTX through Week 48.
|
Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX
n=66 participants at risk
Participants who were treated with golimumab 30 mg/m\^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m\^2 + MTX at anytime during the study through Week 48. Adverse events are reported for participants who switched to golimumab 30 mg/m\^2 + MTX at anytime during the study through Week 48.
|
Group IV: Golimumab + MTX
n=78 participants at risk
Participants were treated with golimumab 30 mg/m\^2 through Week 12 and who were treated with golimumab 30 mg/m\^2 + MTX at Week 16 and continued on golimumab 30 mg/m\^2 + MTX through Week 48.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
10.5%
2/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
30.0%
3/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
27.3%
18/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
26.9%
21/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
9.1%
6/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
11.5%
9/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Pharyngitis streptococcal
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
2.6%
2/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Respiratory tract infection
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
13.6%
9/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
12.8%
10/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
6.1%
4/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
2.6%
2/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
6.1%
4/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
12.8%
10/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.6%
7/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.3%
8/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
9.1%
6/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.3%
8/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
30.0%
3/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
37.9%
25/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
25.6%
20/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
5.1%
4/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Viral infection
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
6.1%
4/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
2.6%
2/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
4.5%
3/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
3.0%
2/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
2.6%
2/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
4.5%
3/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.3%
8/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
9.0%
7/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Investigations
C-reactive protein increased
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
2.6%
2/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
4.5%
3/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
7.7%
6/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Investigations
Neutrophil count increased
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Investigations
Transaminases increased
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Investigations
Weight decreased
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Investigations
White blood cell count increased
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
9.1%
6/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.3%
8/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
3.0%
2/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
3.8%
3/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
3.0%
2/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
2.6%
2/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Musculoskeletal and connective tissue disorders
Juvenile idiopathic arthritis
|
10.5%
2/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
16.7%
11/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
23.1%
18/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
4.5%
3/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
7.7%
6/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
20.0%
2/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
15.2%
10/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
19.2%
15/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Psychiatric disorders
Emotional distress
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
4.5%
3/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
12.8%
10/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
3.0%
2/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
2.6%
2/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
20.0%
2/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.6%
7/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
2.6%
2/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
3.8%
3/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
4.5%
3/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
2.6%
2/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
2.6%
2/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
5.1%
4/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
5.1%
4/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
3.8%
3/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.5%
2/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
6.1%
4/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
7.7%
6/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
5.1%
4/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
6.1%
4/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
3.8%
3/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Cardiac disorders
Palpitations
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Eye disorders
Conjunctivitis
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
7.6%
5/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
9.0%
7/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Eye disorders
Visual impairment
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
20.0%
2/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
12.1%
8/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
9.0%
7/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
15.2%
10/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
2.6%
2/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
6.1%
4/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
7.6%
5/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
2.6%
2/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
5.1%
4/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
13.6%
9/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
9.0%
7/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Gastrointestinal disorders
Nausea
|
10.5%
2/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
20.0%
2/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.6%
7/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
14.1%
11/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Gastrointestinal disorders
Peptic ulcer
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
19.7%
13/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
15.4%
12/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
General disorders
Influenza like illness
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
12.1%
8/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
General disorders
Injection site erythema
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
2.6%
2/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
General disorders
Injection site reaction
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
General disorders
Pain
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
General disorders
Pyrexia
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
22.7%
15/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
11.5%
9/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
General disorders
Serositis
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Hepatobiliary disorders
Hepatomegaly
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
4.5%
3/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
2.6%
2/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Bronchitis
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
6.1%
4/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
7.7%
6/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Gastroenteritis
|
10.5%
2/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
9.1%
6/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.3%
8/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
9.1%
6/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
2.6%
2/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Gingivitis
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.5%
1/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Influenza
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
3.0%
2/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
9.0%
7/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
10.0%
1/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
2.6%
2/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Otitis media
|
0.00%
0/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
7.6%
5/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
7.7%
6/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
|
Infections and infestations
Paronychia
|
5.3%
1/19 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
0.00%
0/10 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
3.0%
2/66 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
1.3%
1/78 • Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m\^2 + MTX and was included in group 3 in safety population.
|
Additional Information
Senior Director Clinical Research
Johnson & Johnson Pharmaceutical Research & Development
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60