Trial Outcomes & Findings for Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA) (NCT NCT01004432)
NCT ID: NCT01004432
Last Updated: 2015-04-30
Results Overview
Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: greater than or equal to (\>=) 20 percent (%) improvement from Baseline in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and \>=20% improvement from Baseline in 3 of the following 5 assessments: 1- Participant's assessment of pain using Visual Analog Scale (VAS) (0 to 10 centimeters \[cm\]), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR.
COMPLETED
PHASE3
433 participants
Week 14
2015-04-30
Participant Flow
Participant milestones
| Measure |
Open-label (OL) Overall Group: Golimumab 50 mg SC + MTX
All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
|
OL Group 1: Golimumab 50 mg SC + MTX
Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
|
Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX
Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
|
DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX
Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
|
OL Study Extension Group: Golimumab 50 mg SC + MTX
Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
|
|---|---|---|---|---|---|
|
Open-label (OL) Period (Week 0 - 16)
STARTED
|
433
|
0
|
0
|
0
|
0
|
|
Open-label (OL) Period (Week 0 - 16)
COMPLETED
|
350
|
0
|
0
|
0
|
0
|
|
Open-label (OL) Period (Week 0 - 16)
NOT COMPLETED
|
83
|
0
|
0
|
0
|
0
|
|
OL/Double-Blind (DB) Period (Week 16-52)
STARTED
|
0
|
75
|
91
|
184
|
0
|
|
OL/Double-Blind (DB) Period (Week 16-52)
COMPLETED
|
0
|
65
|
54
|
126
|
0
|
|
OL/Double-Blind (DB) Period (Week 16-52)
NOT COMPLETED
|
0
|
10
|
37
|
58
|
0
|
|
OL Study Extension (Week 52 - 76)
STARTED
|
0
|
0
|
0
|
0
|
212
|
|
OL Study Extension (Week 52 - 76)
COMPLETED
|
0
|
0
|
0
|
0
|
194
|
|
OL Study Extension (Week 52 - 76)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
18
|
Reasons for withdrawal
| Measure |
Open-label (OL) Overall Group: Golimumab 50 mg SC + MTX
All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
|
OL Group 1: Golimumab 50 mg SC + MTX
Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
|
Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX
Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
|
DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX
Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
|
OL Study Extension Group: Golimumab 50 mg SC + MTX
Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
|
|---|---|---|---|---|---|
|
Open-label (OL) Period (Week 0 - 16)
Adverse Event
|
20
|
0
|
0
|
0
|
0
|
|
Open-label (OL) Period (Week 0 - 16)
Protocol Violation
|
29
|
0
|
0
|
0
|
0
|
|
Open-label (OL) Period (Week 0 - 16)
Withdrawal by Subject
|
17
|
0
|
0
|
0
|
0
|
|
Open-label (OL) Period (Week 0 - 16)
Lack of Efficacy
|
15
|
0
|
0
|
0
|
0
|
|
Open-label (OL) Period (Week 0 - 16)
Lost to Follow-up
|
2
|
0
|
0
|
0
|
0
|
|
OL/Double-Blind (DB) Period (Week 16-52)
Adverse Event
|
0
|
1
|
5
|
6
|
0
|
|
OL/Double-Blind (DB) Period (Week 16-52)
Protocol Violation
|
0
|
3
|
3
|
4
|
0
|
|
OL/Double-Blind (DB) Period (Week 16-52)
Withdrawal by Subject
|
0
|
1
|
4
|
7
|
0
|
|
OL/Double-Blind (DB) Period (Week 16-52)
Death
|
0
|
0
|
0
|
1
|
0
|
|
OL/Double-Blind (DB) Period (Week 16-52)
Lack of Efficacy
|
0
|
2
|
24
|
37
|
0
|
|
OL/Double-Blind (DB) Period (Week 16-52)
Lost to Follow-up
|
0
|
3
|
1
|
3
|
0
|
|
OL Study Extension (Week 52 - 76)
Adverse Event
|
0
|
0
|
0
|
0
|
2
|
|
OL Study Extension (Week 52 - 76)
Protocol Violation
|
0
|
0
|
0
|
0
|
4
|
|
OL Study Extension (Week 52 - 76)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
|
OL Study Extension (Week 52 - 76)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
10
|
Baseline Characteristics
Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA)
Baseline characteristics by cohort
| Measure |
OL Overall Group: Golimumab 50 mg SC + MTX
n=433 Participants
All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
|
|---|---|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 11.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
358 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
37 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
9 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
349 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 14Population: Modified Intent To Treat (mITT) population included all enrolled participants who had Week 0 measurements and received at least 1 dose of study drug.
Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: greater than or equal to (\>=) 20 percent (%) improvement from Baseline in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and \>=20% improvement from Baseline in 3 of the following 5 assessments: 1- Participant's assessment of pain using Visual Analog Scale (VAS) (0 to 10 centimeters \[cm\]), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR.
Outcome measures
| Measure |
OL Overall Group: Golimumab 50 mg SC + MTX
n=433 Participants
All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
|
DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX
Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
|
DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX
Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
|
OL Study Extension Group: Golimumab 50 mg SC + MTX
Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Erythrocyte Sedimentation Rate (ESR)-Based American College of Rheumatology [ACR] 20 Response at Week 14
|
34.9 percentage of participants
Interval 30.4 to 39.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 2 weeks of initiating therapyPopulation: Modified Intent To Treat (mITT) population included all enrolled participants who had Week 0 measurements and received at least 1 dose of study drug.
Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: greater than or equal to (\>=) 20 percent (%) improvement from Baseline in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and \>=20% improvement from Baseline in 3 of the following 5 assessments: 1- Participant's assessment of pain using Visual Analog Scale (VAS) (0 to 10 centimeters \[cm\]), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR.
Outcome measures
| Measure |
OL Overall Group: Golimumab 50 mg SC + MTX
n=433 Participants
All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
|
DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX
Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
|
DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX
Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
|
OL Study Extension Group: Golimumab 50 mg SC + MTX
Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based ACR20 Response at Week 2
|
24.5 percentage of participants
Interval 20.4 to 28.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: Open-label modified Intent To Treat (mITT) population included all participants, who received at least 1 open-label golimumab 50 mg SC injection during the continued open-label/ double-blind treatment period.
Erythrocyte Sedimentation Rate (ESR)-based disease activity score for 28-joints count (DAS28) as defined by European League Against Rheumatism (EULAR), response criteria was used to assess individual response as none, moderate, or good, depending on the extent of change from Baseline and the level of disease activity reached. A participant was classified as having achieved a DAS28 good response if, DAS28 was less than or equal to (\<=) 3.2 at a given visit and improvement from Baseline was \>1.2. Percentage of participants, who achieved ESR-based DAS 28 good response at Week 16 and maintained that response through Week 52, is reported.
Outcome measures
| Measure |
OL Overall Group: Golimumab 50 mg SC + MTX
n=75 Participants
All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
|
DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX
Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
|
DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX
Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
|
OL Study Extension Group: Golimumab 50 mg SC + MTX
Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based Disease Activity Score (DAS28) Response at Week 16 and Maintained Response Through Week 52
|
22.7 percentage of participants
Interval 13.2 to 32.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: Double-blind modified Intent To Treat (mITT) population included participants who were randomized at Week 16 to SC or IV golimumab (Groups 2a and 2b) and received at least 1 dose of study drug after randomization.
Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: \>=20 % improvement from Week 16 in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and \>=20% improvement from Week 16 in 3 of the following 5 assessments: 1- Participant's assessment of pain using VAS (0 to 10 cm), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR. Percentage of participants, who achieved ESR-based ACR 20 responses at Week 52 relative to Week 16, is reported.
Outcome measures
| Measure |
OL Overall Group: Golimumab 50 mg SC + MTX
n=91 Participants
All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
|
DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX
n=184 Participants
Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
|
DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX
Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
|
OL Study Extension Group: Golimumab 50 mg SC + MTX
Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based ACR20 Response at Week 52 Relative to Week 16
|
13.2 percentage of participants
Interval 6.2 to 20.1
|
9.2 percentage of participants
Interval 5.1 to 13.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 76Population: Study extension mITT population included all participants, who were enrolled into the 24-week study extension period at Week 52, and received at least 1 golimumab SC injection during the study extension period. Participants reported in other groups are subgroups of 'Study Extension OL Group' by treatment received in the OL/DB phase (Weeks 16-52).
Erythrocyte Sedimentation Rate (ESR)-based/ C Reactive Protein (CRP)-based ACR 20 response: \>=20 % improvement from Week 16 in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and \>=20% improvement from Week 16 in 3 of the following 5 assessments: 1- Participant's assessment of pain using VAS (0 to 10 cm), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR or CRP. Percentage of participants, who achieved ESR/ CRP-based ACR 20 responses at Week 76 relative to Week 16, is reported.
Outcome measures
| Measure |
OL Overall Group: Golimumab 50 mg SC + MTX
n=63 Participants
All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
|
DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX
n=47 Participants
Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
|
DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX
n=102 Participants
Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
|
OL Study Extension Group: Golimumab 50 mg SC + MTX
n=212 Participants
Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved ESR-based and C-Reactive Protein (CRP)-Based ACR20 Response at Week 76 Relative to Week 16
ESR-based ACR 20 Response
|
7.9 percentage of participants
Interval 1.3 to 14.6
|
8.5 percentage of participants
Interval 0.5 to 16.5
|
15.7 percentage of participants
Interval 8.6 to 22.7
|
11.8 percentage of participants
Interval 7.5 to 16.1
|
|
Percentage of Participants Who Achieved ESR-based and C-Reactive Protein (CRP)-Based ACR20 Response at Week 76 Relative to Week 16
CRP-based ACR 20 Response
|
7.9 percentage of participants
Interval 1.3 to 14.6
|
8.5 percentage of participants
Interval 0.5 to 16.5
|
17.6 percentage of participants
Interval 10.2 to 25.0
|
12.7 percentage of participants
Interval 8.2 to 17.2
|
SECONDARY outcome
Timeframe: Week 52, 76Population: Study extension mITT population. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time point for each arm, respectively. Participants reported in other groups are subgroups of 'Study Extension OL Group' by treatment received in the OL/DB phase (Weeks 16-52).
Erythrocyte Sedimentation Rate (ESR)-based disease activity score for 28-joints count (DAS28) was calculated from number of swollen joint counts (SJC) and tender joint counts (TJC) using 28 joints count, ESR, and patient global assessment of disease activity (participant rated arthritis activity assessment with scores ranging 0 to 10; higher scores indicated greater disease activity). Total ESR-based DAS28 score range: 0 to 9.4, higher score=more disease activity.
Outcome measures
| Measure |
OL Overall Group: Golimumab 50 mg SC + MTX
n=61 Participants
All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
|
DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX
n=40 Participants
Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
|
DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX
n=95 Participants
Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
|
OL Study Extension Group: Golimumab 50 mg SC + MTX
n=196 Participants
Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
|
|---|---|---|---|---|
|
Change in ESR-based DAS28 Score at Week 76 Relative to Week 52
Change at Week 76 (n = 57, 33, 84, 174)
|
-0.136 units on a scale
Standard Deviation 1.2095 • Interval 1.3 to 14.6
|
0.209 units on a scale
Standard Deviation 1.2253 • Interval 0.5 to 16.5
|
-0.017 units on a scale
Standard Deviation 1.0518 • Interval 10.2 to 25.0
|
-0.013 units on a scale
Standard Deviation 1.1386 • Interval 8.2 to 17.2
|
|
Change in ESR-based DAS28 Score at Week 76 Relative to Week 52
Week 52 (n = 61, 40, 95, 196)
|
3.182 units on a scale
Standard Deviation 1.1109 • Interval 1.3 to 14.6
|
4.070 units on a scale
Standard Deviation 0.8037 • Interval 0.5 to 16.5
|
4.394 units on a scale
Standard Deviation 1.2389 • Interval 8.6 to 22.7
|
3.950 units on a scale
Standard Deviation 1.2379 • Interval 7.5 to 16.1
|
Adverse Events
OL Overall Group: Golimumab 50 mg SC + MTX
OL Group 1: Golimumab 50 mg SC + MTX
Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX
DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX
OL Study Extension Group: Golimumab 50 mg SC + MTX
Serious adverse events
| Measure |
OL Overall Group: Golimumab 50 mg SC + MTX
n=433 participants at risk
All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
|
OL Group 1: Golimumab 50 mg SC + MTX
n=75 participants at risk
Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
|
Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX
n=91 participants at risk
Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
|
DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX
n=184 participants at risk
Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
|
OL Study Extension Group: Golimumab 50 mg SC + MTX
n=212 participants at risk
Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/433
|
0.00%
0/75
|
0.00%
0/91
|
0.54%
1/184
|
0.00%
0/212
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/433
|
0.00%
0/75
|
0.00%
0/91
|
0.54%
1/184
|
0.00%
0/212
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/433
|
0.00%
0/75
|
0.00%
0/91
|
0.54%
1/184
|
0.47%
1/212
|
|
Gastrointestinal disorders
Oesophagitis haemorrhagic
|
0.00%
0/433
|
0.00%
0/75
|
1.1%
1/91
|
0.00%
0/184
|
0.00%
0/212
|
|
Infections and infestations
Appendicitis
|
0.23%
1/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.00%
0/212
|
|
Infections and infestations
Cellulitis
|
0.23%
1/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.47%
1/212
|
|
Infections and infestations
Diverticulitis
|
0.23%
1/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.00%
0/212
|
|
Infections and infestations
Gastroenteritis
|
0.23%
1/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.00%
0/212
|
|
Infections and infestations
Gastroenteritis viral
|
0.23%
1/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.00%
0/212
|
|
Infections and infestations
Pneumonia
|
0.23%
1/433
|
0.00%
0/75
|
1.1%
1/91
|
1.1%
2/184
|
0.00%
0/212
|
|
Infections and infestations
Sepsis
|
0.00%
0/433
|
0.00%
0/75
|
0.00%
0/91
|
0.54%
1/184
|
0.00%
0/212
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/433
|
0.00%
0/75
|
0.00%
0/91
|
0.54%
1/184
|
0.00%
0/212
|
|
Infections and infestations
Urosepsis
|
0.23%
1/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.00%
0/212
|
|
Infections and infestations
Wound infection staphylococcal
|
0.23%
1/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.00%
0/212
|
|
Injury, poisoning and procedural complications
Fall
|
0.23%
1/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.00%
0/212
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/433
|
1.3%
1/75
|
0.00%
0/91
|
0.00%
0/184
|
0.00%
0/212
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.23%
1/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.00%
0/212
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.23%
1/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.00%
0/212
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.46%
2/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.00%
0/212
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.23%
1/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.00%
0/212
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/433
|
1.3%
1/75
|
0.00%
0/91
|
0.00%
0/184
|
0.00%
0/212
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.23%
1/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.47%
1/212
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/433
|
1.3%
1/75
|
0.00%
0/91
|
0.00%
0/184
|
0.00%
0/212
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.23%
1/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.00%
0/212
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/433
|
0.00%
0/75
|
1.1%
1/91
|
0.00%
0/184
|
0.00%
0/212
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/433
|
0.00%
0/75
|
0.00%
0/91
|
0.54%
1/184
|
0.00%
0/212
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/433
|
0.00%
0/75
|
0.00%
0/91
|
0.54%
1/184
|
0.00%
0/212
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.23%
1/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.00%
0/212
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/433
|
0.00%
0/75
|
0.00%
0/91
|
0.54%
1/184
|
0.00%
0/212
|
|
Nervous system disorders
Polyneuropathy
|
0.23%
1/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.00%
0/212
|
|
Renal and urinary disorders
Renal failure acute
|
0.23%
1/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.47%
1/212
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/433
|
0.00%
0/75
|
0.00%
0/91
|
0.54%
1/184
|
0.00%
0/212
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.46%
2/433
|
0.00%
0/75
|
1.1%
1/91
|
0.54%
1/184
|
0.00%
0/212
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.23%
1/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.00%
0/212
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/433
|
0.00%
0/75
|
1.1%
1/91
|
0.00%
0/184
|
0.47%
1/212
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.23%
1/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.00%
0/212
|
|
Vascular disorders
Deep vein thrombosis
|
0.23%
1/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.00%
0/212
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.47%
1/212
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.47%
1/212
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.47%
1/212
|
|
General disorders
Chest pain
|
0.23%
1/433
|
0.00%
0/75
|
0.00%
0/91
|
1.6%
3/184
|
0.47%
1/212
|
|
General disorders
Pyrexia
|
0.00%
0/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.47%
1/212
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.47%
1/212
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.47%
1/212
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.47%
1/212
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.47%
1/212
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.47%
1/212
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.47%
1/212
|
|
Vascular disorders
Hypotension
|
0.00%
0/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.47%
1/212
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.23%
1/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.00%
0/212
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage III
|
0.00%
0/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.47%
1/212
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Essential thrombocythaemia
|
0.00%
0/433
|
0.00%
0/75
|
0.00%
0/91
|
0.00%
0/184
|
0.47%
1/212
|
Other adverse events
| Measure |
OL Overall Group: Golimumab 50 mg SC + MTX
n=433 participants at risk
All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
|
OL Group 1: Golimumab 50 mg SC + MTX
n=75 participants at risk
Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
|
Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX
n=91 participants at risk
Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
|
DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX
n=184 participants at risk
Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
|
OL Study Extension Group: Golimumab 50 mg SC + MTX
n=212 participants at risk
Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
|
|---|---|---|---|---|---|
|
Infections and infestations
Bronchitis
|
2.8%
12/433
|
2.7%
2/75
|
6.6%
6/91
|
6.0%
11/184
|
1.9%
4/212
|
|
Infections and infestations
Sinusitis
|
3.9%
17/433
|
5.3%
4/75
|
4.4%
4/91
|
7.1%
13/184
|
5.7%
12/212
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
29/433
|
9.3%
7/75
|
5.5%
5/91
|
8.2%
15/184
|
6.1%
13/212
|
|
Infections and infestations
Urinary tract infection
|
5.5%
24/433
|
4.0%
3/75
|
2.2%
2/91
|
6.0%
11/184
|
6.1%
13/212
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.6%
20/433
|
2.7%
2/75
|
8.8%
8/91
|
4.3%
8/184
|
5.2%
11/212
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
3.0%
13/433
|
2.7%
2/75
|
9.9%
9/91
|
4.9%
9/184
|
5.2%
11/212
|
|
Nervous system disorders
Headache
|
5.5%
24/433
|
0.00%
0/75
|
1.1%
1/91
|
2.7%
5/184
|
1.4%
3/212
|
|
Psychiatric disorders
Depression
|
1.6%
7/433
|
5.3%
4/75
|
3.3%
3/91
|
1.1%
2/184
|
2.4%
5/212
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60