Trial Outcomes & Findings for Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2) (NCT NCT00975130)
NCT ID: NCT00975130
Last Updated: 2017-04-13
Results Overview
EULAR response was assessed at the end of Month 6 by the Disease Activity Score using the 28 tender and swollen joint count calculated with erythrocyte sedimentation rate values (DAS28-ESR). A good response was defined as a decrease \>1.2 units and a final DAS28-ESR \< 3.2 units, while a moderate response was defined as a decrease \> 1.2 units and final DAS28-ESR \>= 3.2 units, OR a decrease of 0.6 to 1.2 units AND final DAS28-ESR \<= 5.1 units
COMPLETED
PHASE3
3366 participants
Month 6
2017-04-13
Participant Flow
Participant milestones
| Measure |
Golimumab 50 mg Subcutaneous (GLM50-SC)
Participants received GLM50-SC once monthly for a period of 6 months in Study Part 1.
|
Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg
Participants achieving good or moderate response but not in remission at the conclusion of Study Part 1 received IV-GLM at a dose of 2 mg/kg at the start of Month 7, start of Month 8, and start of Month 10 if remission was not achieved at any of these IV administration visits. If remission was achieved, participants were switched subcutaneous golimumab at a dose of 50 mg once monthly.
|
SC-GLM50
Participants achieving good or moderate response but not in remission at the end of Study Part 1, received subcutaneous golimumab at a dose of 50 mg once monthly for a period of 6 months in Part 2 of the study.
|
|---|---|---|---|
|
Study Part 1
STARTED
|
3366
|
0
|
0
|
|
Study Part 1
COMPLETED
|
3086
|
0
|
0
|
|
Study Part 1
NOT COMPLETED
|
280
|
0
|
0
|
|
Study Part 2
STARTED
|
0
|
250
|
255
|
|
Study Part 2
COMPLETED
|
0
|
212
|
238
|
|
Study Part 2
NOT COMPLETED
|
0
|
38
|
17
|
Reasons for withdrawal
| Measure |
Golimumab 50 mg Subcutaneous (GLM50-SC)
Participants received GLM50-SC once monthly for a period of 6 months in Study Part 1.
|
Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg
Participants achieving good or moderate response but not in remission at the conclusion of Study Part 1 received IV-GLM at a dose of 2 mg/kg at the start of Month 7, start of Month 8, and start of Month 10 if remission was not achieved at any of these IV administration visits. If remission was achieved, participants were switched subcutaneous golimumab at a dose of 50 mg once monthly.
|
SC-GLM50
Participants achieving good or moderate response but not in remission at the end of Study Part 1, received subcutaneous golimumab at a dose of 50 mg once monthly for a period of 6 months in Part 2 of the study.
|
|---|---|---|---|
|
Study Part 1
Adverse Event
|
150
|
0
|
0
|
|
Study Part 1
Lost to Follow-up
|
19
|
0
|
0
|
|
Study Part 1
Withdrawal by Subject
|
61
|
0
|
0
|
|
Study Part 1
Protocol Violation
|
13
|
0
|
0
|
|
Study Part 1
Did Not Meet Protocol Eligibility
|
9
|
0
|
0
|
|
Study Part 1
Administrative
|
4
|
0
|
0
|
|
Study Part 1
Withdrew Consent
|
24
|
0
|
0
|
|
Study Part 2
Adverse Event
|
0
|
14
|
7
|
|
Study Part 2
Lost to Follow-up
|
0
|
0
|
1
|
|
Study Part 2
Withdrawal by Subject
|
0
|
13
|
5
|
|
Study Part 2
Withdrew Consent
|
0
|
6
|
2
|
|
Study Part 2
Did Not Meet Protocol Eligibility
|
0
|
4
|
1
|
|
Study Part 2
Administrative
|
0
|
1
|
0
|
|
Study Part 2
Protocol Violation
|
0
|
0
|
1
|
Baseline Characteristics
Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2)
Baseline characteristics by cohort
| Measure |
GLM50-SC
n=3280 Participants
Participants received 50 mg of golimumab subcutaneously once monthly for a period of 6 months. 3280 enrolled participants were included in the Efficacy-Evaluable population; baseline characteristics are presented for this population.
|
|---|---|
|
Age, Continuous
|
53 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2716 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
564 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: The Efficacy Evaluable population in Part 1 of the study excluded participants without a DAS28-ESR at baseline and at least 1 post-line value DAS28-ESR or those that had very poor data quality due to incomplete documentation.
EULAR response was assessed at the end of Month 6 by the Disease Activity Score using the 28 tender and swollen joint count calculated with erythrocyte sedimentation rate values (DAS28-ESR). A good response was defined as a decrease \>1.2 units and a final DAS28-ESR \< 3.2 units, while a moderate response was defined as a decrease \> 1.2 units and final DAS28-ESR \>= 3.2 units, OR a decrease of 0.6 to 1.2 units AND final DAS28-ESR \<= 5.1 units
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Number of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Month 6
|
2692 Participants
|
—
|
PRIMARY outcome
Timeframe: Start of Month 11, End of Month 12Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR.
The number of participants experiencing DAS28-ESR remission was evaluated at the start of study Month 11 and the end of study Month 12. The DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR \<2.6.
Outcome measures
| Measure |
GLM50-SC
n=242 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
n=248 Participants
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Number of Participants Experiencing Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at the Start of Month 11 and End of Month 12
Start of Month 11
|
58 Participants
|
64 Participants
|
|
Number of Participants Experiencing Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at the Start of Month 11 and End of Month 12
End of Month 12
|
59 Participants
|
67 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the mean number of swollen joints was calculated at study Month 2, Month 4, and Month 6 by concomitant MTX dose (low \< 10mg/wk, medium \>= 10 to \< 15 mg/week, and high \>=15 mg/week). A total of 28 joints were evaluated.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 4 (n=1995)
|
-6.2 Swollen Joints
Standard Deviation 5.07
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 6 (n=1995)
|
-6.9 Swollen Joints
Standard Deviation 5.30
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 2 (n =142)
|
-4.7 Swollen Joints
Standard Deviation 4.46
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 4 (n=142)
|
-6.3 Swollen Joints
Standard Deviation 5.37
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 6 (n=142)
|
-7.7 Swollen Joints
Standard Deviation 5.59
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 2 (n=526)
|
-4.6 Swollen Joints
Standard Deviation 4.45
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 4 (n=526)
|
-6.2 Swollen Joints
Standard Deviation 4.98
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 6 (n=526)
|
-7.1 Swollen Joints
Standard Deviation 5.37
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 2 (n=1995)
|
-4.5 Swollen Joints
Standard Deviation 4.67
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the number of swollen joints was calculated by participant baseline background DMARD treatment regimen at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 2 (n=216)
|
-4.6 Swollen Joints
Standard Deviation 4.68
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 4 (n=216)
|
-6.0 Swollen Joints
Standard Deviation 5.11
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 2 (n=1681)
|
-4.5 Swollen Joints
Standard Deviation 4.61
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 4 (n=1681)
|
-6.1 Swollen Joints
Standard Deviation 5.07
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 6 (n=1681)
|
-6.9 Swollen Joints
Standard Deviation 5.31
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 2 (n=433)
|
-4.5 Swollen Joints
Standard Deviation 4.91
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 4 (n=433)
|
-6.5 Swollen Joints
Standard Deviation 5.17
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 6 (n=433)
|
-7.3 Swollen Joints
Standard Deviation 5.35
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 6 (n=216)
|
-6.7 Swollen Joints
Standard Deviation 5.54
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 - Month 2 (n=150)
|
-3.8 Swollen Joints
Standard Deviation 4.58
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 -Month 4 (n=150)
|
-5.9 Swollen Joints
Standard Deviation 5.40
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 - Month 6 (n=150)
|
-6.7 Swollen Joints
Standard Deviation 6.10
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 2 (n=106)
|
-4.8 Swollen Joints
Standard Deviation 3.89
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 4 (n=106)
|
-6.0 Swollen Joints
Standard Deviation 4.96
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 6 (n=106)
|
-6.2 Swollen Joints
Standard Deviation 4.86
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 2 (n=303)
|
-3.9 Swollen Joints
Standard Deviation 4.27
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 4 (n=303)
|
-5.6 Swollen Joints
Standard Deviation 4.51
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 6 (n=303)
|
-6.2 Swollen Joints
Standard Deviation 4.90
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the number of swollen joints by participant baseline concomitant corticosteroid treatment was calculated at study Month 2, Month 4, and Month 6 . A total of 28 joints were evaluated.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Swollen Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 2 (n=1202)
|
-4.5 Swollen Joints
Standard Deviation 4.43
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 4 (n=1202)
|
-6.1 Swollen Joints
Standard Deviation 4.88
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 6 (n=1202)
|
-6.8 Swollen Joints
Standard Deviation 5.24
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 2 (n=2078)
|
-4.3 Swollen Joints
Standard Deviation 4.66
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 4 (n=2078)
|
-6.1 Swollen Joints
Standard Deviation 5.10
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 6 (n=2078)
|
-6.9 Swollen Joints
Standard Deviation 5.33
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the mean number of swollen joints by the number of baseline participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Swollen Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 2 (n=1129)
|
-4.7 Swollen Joints
Standard Deviation 4.81
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 4 (n=1129)
|
-6.3 Swollen Joints
Standard Deviation 5.35
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 6 (n=1129)
|
-7.2 Swollen Joints
Standard Deviation 5.50
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 2 (n=1176)
|
-4.4 Swollen Joints
Standard Deviation 4.54
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 4 (n=1176)
|
-6.0 Swollen Joints
Standard Deviation 4.84
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 6 (n=1176)
|
-6.7 Swollen Joints
Standard Deviation 5.24
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 2 (n=974)
|
-4.1 Swollen Joints
Standard Deviation 4.34
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 4 (n=974)
|
-5.8 Swollen Joints
Standard Deviation 4.83
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 6 (n=974)
|
-6.6 Swollen Joints
Standard Deviation 5.10
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the mean number of swollen joints was calculated by the participant duration of disease at study Month 2, Month 4, and Month 6. The participant duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. A total of 28 joints were evaluated.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Swollen Joints by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 2 (n=764)
|
-4.3 Swollen Joints
Standard Deviation 4.63
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 2 (n=899)
|
-4.4 Swollen Joints
Standard Deviation 4.74
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 4 (n= 899)
|
-5.9 Swollen Joints
Standard Deviation 5.08
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 6 (n=899)
|
-6.5 Swollen Joints
Standard Deviation 5.26
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 4 (n=764)
|
-6.0 Swollen Joints
Standard Deviation 5.04
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 6 (n=764)
|
-6.8 Swollen Joints
Standard Deviation 5.41
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 2 (n=692)
|
-4.3 Swollen Joints
Standard Deviation 4.49
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 4 (n=692)
|
-6.1 Swollen Joints
Standard Deviation 4.96
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 6 (n=692)
|
-6.7 Swollen Joints
Standard Deviation 5.40
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 2 (n=924)
|
-4.6 Swollen Joints
Standard Deviation 4.45
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 4 (n=924)
|
-6.2 Swollen Joints
Standard Deviation 4.99
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 6 (n=924)
|
-7.2 Swollen Joints
Standard Deviation 5.13
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the number of swollen joints by participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6 by the participant's level of baseline disease activity, as measured by DAS28-ESR. A total of 28 joints were evaluated. DAS28-ESR \> 5.1 = high disease activity, DAS28-ESR \< 3.2 to \< =5.1 = low disease activity, and DAS28-ESR \<2.6 = remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Swollen Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 2 (n=698)
|
-2.4 Swollen Joints
Standard Deviation 3.33
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 4 (n=698)
|
-3.4 Swollen Joints
Standard Deviation 3.43
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 6 (n=698)
|
-3.8 Swollen Joints
Standard Deviation 3.60
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 2 (n=2572)
|
-4.9 Swollen Joints
Standard Deviation 4.73
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 4 (n=2572)
|
-6.8 Swollen Joints
Standard Deviation 5.13
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 6 (n=2572)
|
-7.7 Swollen Joints
Standard Deviation 5.39
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The change from baseline in the mean number of swollen joints was calculated by the participant baseline level of RF at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Swollen Joints by Baseline Rheumatoid Factor (RF) Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 2 (n=1026)
|
-3.9 Swollen Joints
Standard Deviation 4.36
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Baseline Rheumatoid Factor (RF) Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 4 (n=1026)
|
-5.5 Swollen Joints
Standard Deviation 4.85
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Baseline Rheumatoid Factor (RF) Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 6 (n=1026)
|
-6.2 Swollen Joints
Standard Deviation 5.07
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Baseline Rheumatoid Factor (RF) Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 2 (n=1081)
|
-4.2 Swollen Joints
Standard Deviation 4.47
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Baseline Rheumatoid Factor (RF) Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 4 (n=1081)
|
-5.8 Swollen Joints
Standard Deviation 4.89
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Baseline Rheumatoid Factor (RF) Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 6 (n=1081)
|
-6.4 Swollen Joints
Standard Deviation 5.08
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Baseline Rheumatoid Factor (RF) Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 2 (n=1127)
|
-5.0 Swollen Joints
Standard Deviation 4.83
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Baseline Rheumatoid Factor (RF) Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 4 (n=1127)
|
-6.8 Swollen Joints
Standard Deviation 5.25
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Baseline Rheumatoid Factor (RF) Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 6 (n=1127)
|
-7.8 Swollen Joints
Standard Deviation 5.56
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The change from baseline in the mean number of swollen joints was calculated by the participant baseline level of anti-CCP at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Swollen Joints by Baseline Anti-Cyclic Citrullinated Antibody (Anti-CCP) Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 4 (n=1038)
|
-5.7 Swollen Joints
Standard Deviation 4.89
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Baseline Anti-Cyclic Citrullinated Antibody (Anti-CCP) Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 6 (n=1038)
|
-6.5 Swollen Joints
Standard Deviation 5.16
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Baseline Anti-Cyclic Citrullinated Antibody (Anti-CCP) Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 2 (n=1038)
|
-4.0 Swollen Joints
Standard Deviation 4.44
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Baseline Anti-Cyclic Citrullinated Antibody (Anti-CCP) Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 2 (n=1112)
|
-4.4 Swollen Joints
Standard Deviation 4.41
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Baseline Anti-Cyclic Citrullinated Antibody (Anti-CCP) Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 4 (n=1112)
|
-6.1 Swollen Joints
Standard Deviation 4.92
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Baseline Anti-Cyclic Citrullinated Antibody (Anti-CCP) Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 6 (n=1112)
|
-6.7 Swollen Joints
Standard Deviation 5.23
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Baseline Anti-Cyclic Citrullinated Antibody (Anti-CCP) Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 2 (n=1075)
|
-4.8 Swollen Joints
Standard Deviation 4.86
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Baseline Anti-Cyclic Citrullinated Antibody (Anti-CCP) Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 4 (n=1075)
|
-6.3 Swollen Joints
Standard Deviation 5.30
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Baseline Anti-Cyclic Citrullinated Antibody (Anti-CCP) Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 6 (n=1075)
|
-7.3 Swollen Joints
Standard Deviation 5.51
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The change from baseline in the mean number of swollen joints was calculated by the baseline participant smoking status at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Non-Smoker - Month 2 (n=1963)
|
-4.7 Swollen Joints
Standard Deviation 4.66
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Non-Smoker - Month 4 (n=1963)
|
-6.5 Swollen Joints
Standard Deviation 5.05
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Non-Smoker - Month 6 (n=1963)
|
-7.3 Swollen Joints
Standard Deviation 5.35
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 2 (n=324)
|
-4.4 Swollen Joints
Standard Deviation 4.43
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 4 (n=324)
|
-5.5 Swollen Joints
Standard Deviation 5.22
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 6 (n=324)
|
-6.5 Swollen Joints
Standard Deviation 5.35
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 2 (n=314)
|
-4.0 Swollen Joints
Standard Deviation 4.32
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 4 (n=314)
|
-5.4 Swollen Joints
Standard Deviation 4.64
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 6 (n=314)
|
-6.1 Swollen Joints
Standard Deviation 4.85
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Currently smokes <0.5 packs/day - Month 2 (n=223)
|
-4.0 Swollen Joints
Standard Deviation 4.71
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Currently smokes <0.5 packs/day - Month 4 (n=223)
|
-6.1 Swollen Joints
Standard Deviation 4.87
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Currently smokes <0.5 pack/day - Month 6 (n=223)
|
-6.6 Swollen Joints
Standard Deviation 5.26
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 2 (n=397)
|
-3.6 Swollen Joints
Standard Deviation 4.11
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 4 (n=397)
|
-5.0 Swollen Joints
Standard Deviation 4.59
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 6 (n=397)
|
-5.5 Swollen Joints
Standard Deviation 4.95
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 2 (n=59)
|
-4.0 Swollen Joints
Standard Deviation 5.6
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 4 (n=59)
|
-4.8 Swollen Joints
Standard Deviation 6.25
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 6 (n=59)
|
-5.0 Swollen Joints
Standard Deviation 5.46
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 2 (n=423)
|
-4.2 Swollen Joints
Standard Deviation 4.68
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 4 (n=423)
|
-6.0 Swollen Joints
Standard Deviation 5.04
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 6 (n=423)
|
-6.5 Swollen Joints
Standard Deviation 5.21
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 2 (n=454)
|
-3.8 Swollen Joints
Standard Deviation 4.12
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 4 (n=454)
|
-5.3 Swollen Joints
Standard Deviation 4.84
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 6 (n=454)
|
-5.9 Swollen Joints
Standard Deviation 5.17
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 2 (n=418)
|
-3.9 Swollen Joints
Standard Deviation 4.35
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 4 (n=418)
|
-5.0 Swollen Joints
Standard Deviation 4.77
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 6 (n=418)
|
-5.8 Swollen Joints
Standard Deviation 5.01
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The change from baseline in the mean number of swollen joints was calculated by the baseline participant eligibility for anti-TNF treatment at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Swollen Joints by Eligibility for Anti-Tumor Necrosis Factor (Anti-TNF) Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 2 (n=106)
|
-3.1 Swollen Joints
Standard Deviation 3.34
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Eligibility for Anti-Tumor Necrosis Factor (Anti-TNF) Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 4 (n=106)
|
-4.4 Swollen Joints
Standard Deviation 3.82
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Eligibility for Anti-Tumor Necrosis Factor (Anti-TNF) Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 6 (n=106)
|
-4.5 Swollen Joints
Standard Deviation 3.81
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Eligibility for Anti-Tumor Necrosis Factor (Anti-TNF) Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 2 (n=3174)
|
-4.4 Swollen Joints
Standard Deviation 4.61
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Eligibility for Anti-Tumor Necrosis Factor (Anti-TNF) Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 4 (n=3174)
|
-6.1 Swollen Joints
Standard Deviation 5.05
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Eligibility for Anti-Tumor Necrosis Factor (Anti-TNF) Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 6 (n=3174)
|
-6.9 Swollen Joints
Standard Deviation 5.32
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: \<=1.5, \>1.5 to \<1.86, and \>=1.86.
The mean change from baseline in the number of swollen joints was calculated by the participant baseline expectation of treatment outcome at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Swollen Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 2 (n=1212)
|
-4.8 Swollen Joints
Standard Deviation 4.68
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 4 (n=1212)
|
-6.4 Swollen Joints
Standard Deviation 5.14
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 6 (n=1212)
|
-7.3 Swollen Joints
Standard Deviation 5.40
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 2 (n=1009)
|
-4.4 Swollen Joints
Standard Deviation 4.54
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 4 (n=1009)
|
-6.2 Swollen Joints
Standard Deviation 5.09
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 6 (n=1009)
|
-6.9 Swollen Joints
Standard Deviation 5.28
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 2 (n=1054)
|
-3.9 Swollen Joints
Standard Deviation 4.46
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 4 (n=1054)
|
-5.5 Swollen Joints
Standard Deviation 4.77
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 6 (n=1054)
|
-6.3 Swollen Joints
Standard Deviation 5.13
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the number of swollen joints was calculated by the physician experience level at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 2 (n=1305)
|
-4.2 Swollen Joints
Standard Deviation 4.49
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 4 (n=1305)
|
-5.8 Swollen Joints
Standard Deviation 4.88
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 6 (n =1305)
|
-6.5 Swollen Joints
Standard Deviation 5.13
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 2 (n=1105)
|
-4.7 Swollen Joints
Standard Deviation 4.83
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 4 (n=1105)
|
-6.4 Swollen Joints
Standard Deviation 5.35
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 6 (n=1105)
|
-7.2 Swollen Joints
Standard Deviation 5.42
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 2 (n=850)
|
-4.3 Swollen Joints
Standard Deviation 4.35
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 4 (n=850)
|
-6.0 Swollen Joints
Standard Deviation 4.77
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 6 (n=850)
|
-6.8 Swollen Joints
Standard Deviation 5.32
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the number of swollen joints was calculated by the physician experience level with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 2 (n=1160)
|
-4.2 Swollen Joints
Standard Deviation 4.52
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 4 (n=1160)
|
-5.9 Swollen Joints
Standard Deviation 5.09
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 6 (n=1160)
|
-6.9 Swollen Joints
Standard Deviation 5.35
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 2 (n=1745)
|
-4.5 Swollen Joints
Standard Deviation 4.63
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 4 (n=1745)
|
-6.2 Swollen Joints
Standard Deviation 4.98
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 6 (n=1745)
|
-6.8 Swollen Joints
Standard Deviation 5.26
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 2 (n=355)
|
-4.3 Swollen Joints
Standard Deviation 4.49
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 4 (n=355)
|
-5.9 Swollen Joints
Standard Deviation 4.98
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 6 (n=355)
|
-6.6 Swollen Joints
Standard Deviation 5.18
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the number of swollen joints was calculated by the baseline number of patients the physician treats with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The number of patients treated with biologics is defined as the number of patients treated by the physician in the last month with biologics for rheumatoid arthritis.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Swollen Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 2 (n=1056)
|
-4.3 Swollen Joints
Standard Deviation 4.59
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 4 (n=1056)
|
-6.2 Swollen Joints
Standard Deviation 5.00
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 6 (n=1056)
|
-7.4 Swollen Joints
Standard Deviation 5.40
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 2 (n=1061)
|
-4.5 Swollen Joints
Standard Deviation 4.52
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 4 (n=1061)
|
-6.1 Swollen Joints
Standard Deviation 4.98
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 6 (n=1061)
|
-6.8 Swollen Joints
Standard Deviation 5.02
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 2 (n=1097)
|
-4.5 Swollen Joints
Standard Deviation 4.60
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 4 (n=1097)
|
-6.1 Swollen Joints
Standard Deviation 4.98
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 6 (n=1097)
|
-6.8 Swollen Joints
Standard Deviation 5.02
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the number of swollen joints was calculated by the physician's expectation of treatment outcome at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The physician's expectation of treatment outcomes was assessed at the start of Month 4 at which time physicians were asked to rate their expectations of treatment outcome in each participant as: high disease activity, moderate disease activity, low disease activity, or remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Swollen Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 2 (n=40)
|
-5.5 Swollen Joints
Standard Deviation 4.74
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 4 (n=40)
|
-7.1 Swollen Joints
Standard Deviation 4.21
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 6 (n=40)
|
-8.2 Swollen Joints
Standard Deviation 4.77
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 2 (n=325)
|
-4.9 Swollen Joints
Standard Deviation 4.98
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 4 (n=325)
|
-6.3 Swollen Joints
Standard Deviation 4.94
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 6 (n=325)
|
-7.2 Swollen Joints
Standard Deviation 5.75
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 2 (n=1932)
|
-4.2 Swollen Joints
Standard Deviation 4.53
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 4 (n=1932)
|
-6.0 Swollen Joints
Standard Deviation 5.12
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 6 (n=1932)
|
-6.9 Swollen Joints
Standard Deviation 5.23
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 2 (n=966)
|
-4.6 Swollen Joints
Standard Deviation 4.50
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 4 (n=966)
|
-6.0 Swollen Joints
Standard Deviation 4.84
|
—
|
|
Mean Change From Baseline in the Number of Swollen Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 6 (n=966)
|
-6.5 Swollen Joints
Standard Deviation 5.24
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the number of tender joints was calculated by participant concomitant MTX dose (low \< 10mg/wk, medium \>= 10 to \< 15 mg/week, and high \>=15 mg/week) at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 4 (n=142)
|
-7.9 Tender Joints
Standard Deviation 6.67
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 2 (n=142)
|
-5.5 Tender Joints
Standard Deviation 5.82
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 6 (n=142)
|
-9.0 Tender Joints
Standard Deviation 6.82
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 2 (n=526)
|
-5.6 Tender Joints
Standard Deviation 5.76
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 4 (n=526)
|
-8.0 Tender Joints
Standard Deviation 6.52
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 6 (n=526)
|
-9.1 Tender Joints
Standard Deviation 6.57
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 2 (n=1995)
|
-5.5 Tender Joints
Standard Deviation 5.91
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 4 (n=1995)
|
-7.8 Tender Joints
Standard Deviation 6.48
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 6 (n=1995)
|
-8.7 Tender Joints
Standard Deviation 6.72
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the number of tender joints was calculated by participant background DMARD treatment at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 2 (n=1681)
|
-5.5 Tender Joints
Standard Deviation 5.56
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 4 (n=1681)
|
-7.8 Tender Joints
Standard Deviation 6.39
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 6 (n=1681)
|
-8.7 Tender Joints
Standard Deviation 6.58
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 2 (n=433)
|
-5.7 Tender Joints
Standard Deviation 6.37
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 4 (n=433)
|
-8.0 Tender Joints
Standard Deviation 6.81
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 6 (n=433)
|
-9.2 Tender Joints
Standard Deviation 6.46
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 2 (n=216)
|
-5.6 Tender Joints
Standard Deviation 6.86
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 4 (n=216)
|
-7.6 Tender Joints
Standard Deviation 6.87
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 6 (n=216)
|
-8.2 Tender Joints
Standard Deviation 7.52
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 - Month 2 (n=150)
|
-5.5 Tender Joints
Standard Deviation 6.11
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 -Month 4 (n=150)
|
-8.0 Tender Joints
Standard Deviation 6.92
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 - Month 6 (n=150)
|
-9.2 Tender Joints
Standard Deviation 7.44
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 2 (n=106)
|
-5.4 Tender Joints
Standard Deviation 5.72
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 4 (n=106)
|
-8.3 Tender Joints
Standard Deviation 5.81
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 6 (n=106)
|
-8.4 Tender Joints
Standard Deviation 7.07
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 2 (n=303)
|
-5.1 Tender Joints
Standard Deviation 5.77
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 4 (n=303)
|
-7.5 Tender Joints
Standard Deviation 6.37
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 6 (n=303)
|
-8.0 Tender Joints
Standard Deviation 6.68
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the number of tender joints was calculated by participant baseline concomitant steroid treatment at study Month 2, Month 4, and Month 6. A total 28 joints were evaluated.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 2 (n=1202)
|
-5.4 Tender Joints
Standard Deviation 5.54
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 4 (n=1202)
|
-7.6 Tender Joints
Standard Deviation 6.31
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 6 (n=1202)
|
-8.6 Tender Joints
Standard Deviation 6.44
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 2 (n=2078)
|
-5.6 Tender Joints
Standard Deviation 5.99
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 4 (n=2078)
|
-7.8 Tender Joints
Standard Deviation 6.61
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 6 (n=2078)
|
-8.7 Tender Joints
Standard Deviation 6.85
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the number of tender joints was calculated by the number of participant DMARD failures at baseline at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Tender Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 2 (n=1176)
|
-5.5 Tender Joints
Standard Deviation 6.02
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 4 (n=1176)
|
-7.7 Tender Joints
Standard Deviation 6.64
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 6 (n=1176)
|
-8.7 Tender Joints
Standard Deviation 6.64
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 2 (n=974)
|
-5.1 Tender Joints
Standard Deviation 5.68
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 4 (n=974)
|
-7.6 Tender Joints
Standard Deviation 6.15
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 6 (n=974)
|
-8.4 Tender Joints
Standard Deviation 6.48
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 2 (n=1129)
|
-5.8 Tender Joints
Standard Deviation 5.74
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 4 (n=1129)
|
-7.8 Tender Joints
Standard Deviation 6.65
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 6 (n=1129)
|
-8.8 Tender Joints
Standard Deviation 6.94
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the number of tender joints was calculated by the participant duration of disease at study Month 2, Month 4, and Month 6. Duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. A total of 28 joints were evaluated.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Tender Joints by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 2 (n=899)
|
-5.4 Tender Joints
Standard Deviation 6.03
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 4 (n=899)
|
-7.4 Tender Joints
Standard Deviation 6.78
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 6 (n=899)
|
-8.3 Tender Joints
Standard Deviation 6.59
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 2 (n=764)
|
-5.9 Tender Joints
Standard Deviation 5.95
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 4 (n=764)
|
-8.2 Tender Joints
Standard Deviation 6.43
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 6 (n=764)
|
-8.9 Tender Joints
Standard Deviation 6.86
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 2 (n=692)
|
-5.3 Tender Joints
Standard Deviation 5.52
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 4 (n=692)
|
-7.7 Tender Joints
Standard Deviation 6.27
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 6 (n=692)
|
-8.6 Tender Joints
Standard Deviation 6.66
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 2 (n=924)
|
-5.4 Tender Joints
Standard Deviation 5.74
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 4 (n=924)
|
-7.6 Tender Joints
Standard Deviation 6.45
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 6 (n=924)
|
-8.7 Tender Joints
Standard Deviation 6.67
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the number of tender joints was calculated by the participant baseline level of disease activity, as measured by DAS28, at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DAS28-ESR \> 5.1 = high disease activity, DAS28-ESR \< 3.2 to \< =5.1 = low disease activity, and DAS28-ESR \<2.6 = remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Tender Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 2 (n=698)
|
-2.9 Tender Joints
Standard Deviation 4.10
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 4 (n=698)
|
-3.8 Tender Joints
Standard Deviation 4.42
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 6 (n=698)
|
-4.0 Tender Joints
Standard Deviation 4.59
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 2 (n=2572)
|
-6.2 Tender Joints
Standard Deviation 6.00
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 4 (n=2572)
|
-8.8 Tender Joints
Standard Deviation 6.55
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 6 (n=2572)
|
-9.9 Tender Joints
Standard Deviation 6.62
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The change from baseline in the mean number of tender joints was calculated by the participant baseline level of RF at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Tender Joints by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 2 (n=1026)
|
-5.0 Tender Joints
Standard Deviation 5.82
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 4 (n=1026)
|
-7.2 Tender Joints
Standard Deviation 6.60
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 6 (n=1026)
|
-8.1 Tender Joints
Standard Deviation 6.76
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 2 (n=1081)
|
-5.4 Tender Joints
Standard Deviation 5.46
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 4 (n=1081)
|
-7.6 Tender Joints
Standard Deviation 6.20
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 6 (n=1081)
|
-8.5 Tender Joints
Standard Deviation 6.36
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 2 (n=1127)
|
-6.1 Tender Joints
Standard Deviation 6.16
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 4 (n=1127)
|
-8.3 Tender Joints
Standard Deviation 6.69
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 6 (n=1127)
|
-9.3 Tender Joints
Standard Deviation 6.97
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the number of tender joints was calculated by the participant baseline level of anti-CCP at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Tender Joints by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 2 (n=1038)
|
-5.0 Tender Joints
Standard Deviation 5.78
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 4 (n=1038)
|
-7.2 Tender Joints
Standard Deviation 6.64
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 6 (n=1038)
|
-8.1 Tender Joints
Standard Deviation 6.73
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 2 (n=1112)
|
-5.7 Tender Joints
Standard Deviation 5.73
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 4 (n=1112)
|
-8.0 Tender Joints
Standard Deviation 6.39
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 6 (n=1112)
|
-8.8 Tender Joints
Standard Deviation 6.72
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 2 (n=1075)
|
-5.8 Tender Joints
Standard Deviation 5.95
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 4 (n=1075)
|
-7.9 Tender Joints
Standard Deviation 6.49
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 6 (n=1075)
|
-9.0 Tender Joints
Standard Deviation 6.65
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the number of tender joints was calculated by the baseline participant smoking status at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 2 (n=324)
|
-5.5 Tender Joints
Standard Deviation 5.97
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 4 (n=324)
|
-7.4 Tender Joints
Standard Deviation 6.73
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Non-Smoker - Month 2 (n=1963)
|
-5.8 Tender Joints
Standard Deviation 5.86
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Non-Smoker - Month 4 (n=1963)
|
-8.2 Tender Joints
Standard Deviation 6.49
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Non-Smoker - Month 6 (n=1963)
|
-9.2 Tender Joints
Standard Deviation 6.59
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 6 (n=324)
|
-8.7 Tender Joints
Standard Deviation 6.77
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 2 (n=314)
|
-5.7 Tender Joints
Standard Deviation 5.74
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 4 (n=314)
|
-7.5 Tender Joints
Standard Deviation 6.12
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 6 (n=314)
|
-8.4 Tender Joints
Standard Deviation 6.51
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Currently smokes <0.5 packs/day - Month 2 (n=223)
|
-4.6 Tender Joints
Standard Deviation 5.11
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Currently smokes <0.5 packs/day - Month 4 (n=223)
|
-7.2 Tender Joints
Standard Deviation 6.67
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Currently smokes <0.5 pack/day - Month 6 (n=223)
|
-8.2 Tender Joints
Standard Deviation 6.84
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 2 (n=397)
|
-4.4 Tender Joints
Standard Deviation 5.67
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 4 (n=397)
|
-6.4 Tender Joints
Standard Deviation 6.36
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 6 (n=397)
|
-6.7 Tender Joints
Standard Deviation 6.70
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 2 (n=59)
|
-5.2 Tender Joints
Standard Deviation 6.83
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 4 (n=59)
|
-6.9 Tender Joints
Standard Deviation 6.49
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 6 (n=59)
|
-7.5 Tender Joints
Standard Deviation 7.64
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 2 (n=423)
|
-5.4 Tender Joints
Standard Deviation 5.51
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 4 (n=423)
|
-7.5 Tender Joints
Standard Deviation 6.37
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 6 (n=423)
|
-8.4 Tender Joints
Standard Deviation 6.77
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 2 (n=454)
|
-5.2 Tender Joints
Standard Deviation 5.67
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 4 (n=454)
|
-7.6 Tender Joints
Standard Deviation 6.37
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 6 (n=454)
|
-8.1 Tender Joints
Standard Deviation 6.80
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 2 (n=418)
|
-4.5 Tender Joints
Standard Deviation 5.76
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 4 (n=418)
|
-6.1 Tender Joints
Standard Deviation 6.29
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 6 (n=418)
|
-7.1 Tender Joints
Standard Deviation 6.61
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the number of tender joints was calculated by the baseline participant eligibility for anti-TNF treatment at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Tender Joints by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 2 (n=106)
|
-4.6 Tender Joints
Standard Deviation 4.75
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 4 (n=106)
|
-7.0 Tender Joints
Standard Deviation 5.68
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 6 (n=106)
|
-7.0 Tender Joints
Standard Deviation 5.70
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 2 (n=3174)
|
-5.5 Tender Joints
Standard Deviation 5.86
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 4 (n=3174)
|
-7.7 Tender Joints
Standard Deviation 6.53
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 6 (n=3174)
|
-8.7 Tender Joints
Standard Deviation 6.72
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: \<=1.5, \>1.5 to \<1.86, and \>=1.86.
The mean change from baseline in the number of tender joints was calculated by the participant baseline expectation of treatment outcome at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Tender Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 2 (n=1212)
|
-6.1 Tender Joints
Standard Deviation 5.97
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 4 (n=1212)
|
-8.2 Tender Joints
Standard Deviation 6.40
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 6 (n=1212)
|
-9.2 Tender Joints
Standard Deviation 6.69
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 2 (n=1009)
|
-5.5 Tender Joints
Standard Deviation 5.73
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 4 (n=1009)
|
-7.9 Tender Joints
Standard Deviation 6.67
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 6 (n=1009)
|
-8.8 Tender Joints
Standard Deviation 6.77
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 2 (n=1054)
|
-4.8 Tender Joints
Standard Deviation 5.67
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 4 (n=1054)
|
-6.9 Tender Joints
Standard Deviation 6.39
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 6 (n=1054)
|
-7.8 Tender Joints
Standard Deviation 6.58
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the number of tender joints was calculated by the physician experience level at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 2 (n=1305)
|
-5.3 Tender Joints
Standard Deviation 5.80
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 4 (n=1305)
|
-7.9 Tender Joints
Standard Deviation 6.41
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 6 (n=1305)
|
-8.7 Tender Joints
Standard Deviation 6.58
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 2 (n=1105)
|
-5.6 Tender Joints
Standard Deviation 5.80
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 4 (n=1105)
|
-7.7 Tender Joints
Standard Deviation 6.48
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 6 (n=1105)
|
-8.8 Tender Joints
Standard Deviation 6.59
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 2 (n=850)
|
-5.5 Tender Joints
Standard Deviation 5.89
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 4 (n=850)
|
-7.6 Tender Joints
Standard Deviation 6.69
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 6 (n=850)
|
-8.4 Tender Joints
Standard Deviation 7.01
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the number of tender joints was calculated by the physician experience level with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 6 (n=1160)
|
-8.9 Tender Joints
Standard Deviation 6.76
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 2 (n=1745)
|
-5.5 Tender Joints
Standard Deviation 5.78
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 2 (n=1160)
|
-5.5 Tender Joints
Standard Deviation 5.93
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 4 (n=1160)
|
-8.0 Tender Joints
Standard Deviation 6.54
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 4 (n=1745)
|
-7.6 Tender Joints
Standard Deviation 6.51
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 6 (n=1745)
|
-8.6 Tender Joints
Standard Deviation 6.61
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 2 (n=355)
|
-5.3 Tender Joints
Standard Deviation 5.66
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 4 (n=355)
|
-7.4 Tender Joints
Standard Deviation 6.34
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 6 (n=355)
|
-8.0 Tender Joints
Standard Deviation 6.90
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the number of tender joints was calculated by the baseline number of patients the physician treats with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The number of patients treated with biologics is defined as the number of patients treated by the physician in the last month with biologics for rheumatoid arthritis.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Tender Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 2 (n=1056)
|
-5.5 Tender Joints
Standard Deviation 5.95
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 4 (n=1056)
|
-8.0 Tender Joints
Standard Deviation 6.33
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 6 (n=1056)
|
-9.2 Tender Joints
Standard Deviation 6.62
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 2 (n=1061)
|
-5.7 Tender Joints
Standard Deviation 5.69
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 4 (n=1061)
|
-7.8 Tender Joints
Standard Deviation 6.59
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 6 (n=1061)
|
-8.6 Tender Joints
Standard Deviation 6.44
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 2 (n=1097)
|
-5.3 Tender Joints
Standard Deviation 5.79
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 4 (n=1097)
|
-7.5 Tender Joints
Standard Deviation 6.54
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 6 (n=1097)
|
-8.2 Tender Joints
Standard Deviation 6.93
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the number of tender joints. was calculated by the physician's expectation of treatment outcome at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The physician's expectation of treatment outcomes was assessed at the start of Month 4 at which time physicians were asked to rate their expectations of treatment outcome in each participant as: high disease activity, moderate disease activity, low disease activity, or remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Number of Tender Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 2 (n=40)
|
-7.2 Tender Joints
Standard Deviation 5.80
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 4 (n=40)
|
-9.4 Tender Joints
Standard Deviation 6.32
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 6 (n=40)
|
-10.4 Tender Joints
Standard Deviation 6.32
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 2 (n=325)
|
-5.0 Tender Joints
Standard Deviation 6.02
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 4 (n=325)
|
-7.3 Tender Joints
Standard Deviation 6.83
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 6 (n=325)
|
-8.3 Tender Joints
Standard Deviation 6.82
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 2 (n=1932)
|
-5.5 Tender Joints
Standard Deviation 5.86
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 4 (n=1932)
|
-7.9 Tender Joints
Standard Deviation 6.58
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 6 (n=1932)
|
-8.9 Tender Joints
Standard Deviation 6.85
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 2 (n=966)
|
-5.6 Tender Joints
Standard Deviation 5.68
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 4 (n=966)
|
-7.5 Tender Joints
Standard Deviation 6.22
|
—
|
|
Mean Change From Baseline in the Number of Tender Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 6 (n=966)
|
-8.3 Tender Joints
Standard Deviation 6.32
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in participant global assessment of disease activity was calculated by concomitant MTX dose (low \< 10mg/wk, medium \>= 10 to \< 15 mg/week, and high \>=15 mg/week) at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a visual analogue scale (VAS; 0mm \[best\] -100mm \[worst\]) with increasing scores indicating increased level of disease.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 6 (n=142)
|
-27.9 Score on a Scale
Standard Deviation 29.33
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 2 (n=526)
|
-22.6 Score on a Scale
Standard Deviation 22.99
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 4 (n=526)
|
-28.9 Score on a Scale
Standard Deviation 24.93
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 6 (n=526)
|
-32.4 Score on a Scale
Standard Deviation 27.85
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 2 (n=142)
|
-23.1 Score on a Scale
Standard Deviation 24.89
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 4 (n=142)
|
-29.3 Score on a Scale
Standard Deviation 26.58
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 2 (n=1995)
|
-20.3 Score on a Scale
Standard Deviation 25.07
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 4 (n=1995)
|
-26.2 Score on a Scale
Standard Deviation 27.46
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 6 (n=1995)
|
-30.0 Score on a Scale
Standard Deviation 28.68
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The participant global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 2 (n=433)
|
-19.2 Score on a Scale
Standard Deviation 24.84
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 2 (n=1681)
|
-21.2 Score on a Scale
Standard Deviation 24.61
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 4 (n=1681)
|
-27.5 Score on a Scale
Standard Deviation 27.23
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 6 (n=1681)
|
-30.7 Score on a Scale
Standard Deviation 28.48
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 4 (n=433)
|
-26.4 Score on a Scale
Standard Deviation 27.18
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 6 (n=433)
|
-30.8 Score on a Scale
Standard Deviation 29.14
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 2 (n=216)
|
-19.8 Score on a Scale
Standard Deviation 25.82
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 4 (n=216)
|
-23.8 Score on a Scale
Standard Deviation 28.38
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 6 (n=216)
|
-26.4 Score on a Scale
Standard Deviation 28.74
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 - Month 2 (n=150)
|
-23.3 Score on a Scale
Standard Deviation 25.13
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 -Month 4 (n=150)
|
-27.2 Score on a Scale
Standard Deviation 24.16
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 - Month 6 (n=150)
|
-32.1 Score on a Scale
Standard Deviation 28.95
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 2 (n=106)
|
-21.1 Score on a Scale
Standard Deviation 23.93
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 4 (n=106)
|
-27.3 Score on a Scale
Standard Deviation 24.14
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 6 (n=106)
|
-28.9 Score on a Scale
Standard Deviation 28.75
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 2 (n=303)
|
-21.8 Score on a Scale
Standard Deviation 24.95
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 4 (n=303)
|
-26.5 Score on a Scale
Standard Deviation 28.61
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 6 (n=303)
|
-29.5 Score on a Scale
Standard Deviation 29.29
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the participant global assessment of disease activity by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 2 (n=2078)
|
-21.3 Score on a Scale
Standard Deviation 25.04
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 4 (n=2078)
|
-26.4 Score on a Scale
Standard Deviation 27.33
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 2 (n=1202)
|
-20.5 Score on a Scale
Standard Deviation 23.98
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 4 (n=1202)
|
-27.0 Score on a Scale
Standard Deviation 26.90
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 6 (n=1202)
|
-29.2 Score on a Scale
Standard Deviation 28.68
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 6 (n=2078)
|
-30.7 Score on a Scale
Standard Deviation 28.42
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the participant global assessment of disease activity score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 6 (n=1176)
|
-30.1 Score on a Scale
Standard Deviation 28.58
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 2 (n=1129)
|
-20.9 Score on a Scale
Standard Deviation 23.98
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 4 (n=1129)
|
-27.1 Score on a Scale
Standard Deviation 28.25
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 6 (n=1129)
|
-29.9 Score on a Scale
Standard Deviation 29.42
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 2 (n=1176)
|
-20.8 Score on a Scale
Standard Deviation 24.56
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 4 (n=1176)
|
-26.1 Score on a Scale
Standard Deviation 26.67
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 2 (n=974)
|
-21.3 Score on a Scale
Standard Deviation 23.73
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 4 (n=974)
|
-26.8 Score on a Scale
Standard Deviation 26.52
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 6 (n=974)
|
-30.4 Score on a Scale
Standard Deviation 27.43
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the participant global assessment of disease activity by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The participant global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 4 (n=764)
|
-25.9 Score on a Scale
Standard Deviation 27.38
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 6 (n=764)
|
-28.9 Score on a Scale
Standard Deviation 28.26
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 2 (n=692)
|
-22.2 Score on a Scale
Standard Deviation 24.76
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 6 (n=924)
|
-31.8 Score on a Scale
Standard Deviation 27.91
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 2 (n=899)
|
-19.4 Score on a Scale
Standard Deviation 25.51
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 4 (n=899)
|
-25.6 Score on a Scale
Standard Deviation 28.21
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 6 (n=899)
|
-29.5 Score on a Scale
Standard Deviation 29.45
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 2 (n=764)
|
-20.9 Score on a Scale
Standard Deviation 24.33
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 4 (n=692)
|
-27.8 Score on a Scale
Standard Deviation 26.51
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 6 (n=692)
|
-30.2 Score on a Scale
Standard Deviation 28.36
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 2 (n=924)
|
-21.8 Score on a Scale
Standard Deviation 23.96
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 4 (n=924)
|
-27.3 Score on a Scale
Standard Deviation 26.46
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the participant global assessment of disease activity by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 2 (n=698)
|
-16.0 Score on a Scale
Standard Deviation 23.68
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 4 (n=698)
|
-20.0 Score on a Scale
Standard Deviation 26.21
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 6 (n=698)
|
-22.6 Score on a Scale
Standard Deviation 27.31
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 2 (n=2572)
|
-22.4 Score on a Scale
Standard Deviation 24.73
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 4 (n=2572)
|
-28.5 Score on a Scale
Standard Deviation 27.15
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 6 (n=2572)
|
-32.3 Score on a Scale
Standard Deviation 28.47
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the participant global assessment of disease activity by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 2 (n=1026)
|
18.0 Score on a Scale
Standard Deviation 24.82
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 4 (n=1026)
|
-24.7 Score on a Scale
Standard Deviation 27.89
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 6 (n=1026)
|
-27.6 Score on a Scale
Standard Deviation 28.48
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 2 (n=1081)
|
-20.7 Score on a Scale
Standard Deviation 24.07
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 4 (n=1081)
|
-25.7 Score on a Scale
Standard Deviation 26.77
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 6 (n=1081)
|
-28.5 Score on a Scale
Standard Deviation 28.15
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 2 (n=1127)
|
-24.2 Score on a Scale
Standard Deviation 24.81
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 4 (n=1127)
|
-29.6 Score on a Scale
Standard Deviation 26.72
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 6 (n=1127)
|
-34.2 Score on a Scale
Standard Deviation 28.54
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the participant global assessment of disease activity by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 2 (n=1038)
|
-17.2 Score on a Scale
Standard Deviation 24.22
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 4 (n=1112)
|
-28.1 Score on a Scale
Standard Deviation 27.86
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 6 (n=1112)
|
-29.7 Score on a Scale
Standard Deviation 28.88
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 2 (n=1075)
|
-23.1 Score on a Scale
Standard Deviation 23.99
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 4 (n=1075)
|
-28.4 Score on a Scale
Standard Deviation 26.44
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 4 (n=1038)
|
-23.3 Score on a Scale
Standard Deviation 27.04
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 6 (n=1038)
|
-27.4 Score on a Scale
Standard Deviation 28.21
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 2 (n=1112)
|
-22.6 Score on a Scale
Standard Deviation 25.23
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 6 (n=1075)
|
-33.3 Score on a Scale
Standard Deviation 28.26
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the participant global assessment of disease activity by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 6 (n=454)
|
-28.4 Score on a Scale
Standard Deviation 29.04
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 2 (n=418)
|
-20.6 Score on a Scale
Standard Deviation 25.00
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Non-Smoker - Month 2 (n=1963)
|
-20.7 Score on a Scale
Standard Deviation 24.43
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Non-Smoker - Month 4 (n=1963)
|
-27.3 Score on a Scale
Standard Deviation 26.73
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Non-Smoker - Month 6 (n=1963)
|
-31.5 Score on a Scale
Standard Deviation 27.99
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 2 (n=324)
|
-21.1 Score on a Scale
Standard Deviation 25.34
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 4 (n=324)
|
-26.2 Score on a Scale
Standard Deviation 27.96
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 6 (n=324)
|
-29.9 Score on a Scale
Standard Deviation 28.05
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 2 (n=314)
|
-24.2 Score on a Scale
Standard Deviation 24.92
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 4 (n=314)
|
-28.5 Score on a Scale
Standard Deviation 27.04
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 6 (n=314)
|
-31.2 Score on a Scale
Standard Deviation 27.73
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes <0.5 packs/day - Month 2 (n=223)
|
-17.5 Score on a Scale
Standard Deviation 23.82
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes <0.5 packs/day - Month 4 (n=223)
|
-24.0 Score on a Scale
Standard Deviation 27.76
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes <0.5 pack/day - Month 6 (n=223)
|
-26.3 Score on a Scale
Standard Deviation 29.99
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 2 (n=397)
|
-21.3 Score on a Scale
Standard Deviation 24.57
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 4 (n=397)
|
-24.7 Score on a Scale
Standard Deviation 27.65
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 6 (n=397)
|
-26.3 Score on a Scale
Standard Deviation 30.57
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 2 (n=59)
|
-21.9 Score on a Scale
Standard Deviation 29.42
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 4 (n=59)
|
-20.7 Score on a Scale
Standard Deviation 31.65
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 6 (n=59)
|
-22.8 Score on a Scale
Standard Deviation 29.35
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 2 (n=423)
|
-21.9 Score on a Scale
Standard Deviation 25.21
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 4 (n=423)
|
-26.4 Score on a Scale
Standard Deviation 27.80
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 6 (n=423)
|
-29.8 Score on a Scale
Standard Deviation 28.76
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 2 (n=454)
|
-21.4 Score on a Scale
Standard Deviation 24.97
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 4 (n=454)
|
-27.3 Score on a Scale
Standard Deviation 26.86
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 4 (n=418)
|
-23.2 Score on a Scale
Standard Deviation 28.82
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 6 (n=418)
|
-26.3 Score on a Scale
Standard Deviation 28.89
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the participant global assessment of disease activity by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 2 (n=106)
|
-18.9 Score on a Scale
Standard Deviation 21.65
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 4 (n=106)
|
-24.7 Score on a Scale
Standard Deviation 24.02
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 6 (n=106)
|
-25.8 Score on a Scale
Standard Deviation 27.59
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 2 (n=3174)
|
-21.0 Score on a Scale
Standard Deviation 24.75
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 4 (n=3174)
|
-26.7 Score on a Scale
Standard Deviation 27.27
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 6 (n=3174)
|
-30.3 Score on a Scale
Standard Deviation 28.54
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: \<=1.5, \>1.5 to \<1.86, and \>=1.86.
The mean change from baseline in the participant global assessment of disease activity by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 2 (n=1212)
|
-23.9 Score on a Scale
Standard Deviation 25.79
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 4 (n=1212)
|
-29.5 Score on a Scale
Standard Deviation 28.50
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 6 (n=1212)
|
-33.9 Score on a Scale
Standard Deviation 28.65
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 2 (n=1009)
|
-21.3 Score on a Scale
Standard Deviation 24.59
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 4 (n=1009)
|
-27.0 Score on a Scale
Standard Deviation 27.03
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 6 (n=1009)
|
-30.3 Score on a Scale
Standard Deviation 28.79
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 2 (n=1054)
|
-17.3 Score on a Scale
Standard Deviation 22.83
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 4 (n=1054)
|
-22.8 Score on a Scale
Standard Deviation 25.20
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 6 (n=1054)
|
-25.6 Score on a Scale
Standard Deviation 27.53
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the participant global assessment of disease activity by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 2 (n=1305)
|
-21.0 Score on a Scale
Standard Deviation 24.66
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 4 (n=1305)
|
-26.2 Score on a Scale
Standard Deviation 26.73
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 6 (n=1305)
|
-29.6 Score on a Scale
Standard Deviation 28.41
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 2 (n=1105)
|
-20.8 Score on a Scale
Standard Deviation 24.01
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 4 (n=1105)
|
-27.5 Score on a Scale
Standard Deviation 26.88
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 6 (n=1105)
|
-31.1 Score on a Scale
Standard Deviation 28.37
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 2 (n=850)
|
-21.3 Score on a Scale
Standard Deviation 25.30
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 4 (n=850)
|
-26.2 Score on a Scale
Standard Deviation 28.21
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 6 (n=850)
|
-29.8 Score on a Scale
Standard Deviation 28.72
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the participant global assessment of disease activity by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
mm [Best]Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 2 (n=1160)
|
-21.2 Score on a Scale
Standard Deviation 24.02
|
—
|
|
mm [Best]Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 4 (n=1160)
|
-26.8 Score on a Scale
Standard Deviation 25.74
|
—
|
|
mm [Best]Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 6 (n=1160)
|
-30.4 Score on a Scale
Standard Deviation 27.68
|
—
|
|
mm [Best]Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 2 (n=1745)
|
-20.9 Score on a Scale
Standard Deviation 24.99
|
—
|
|
mm [Best]Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 4 (n=1745)
|
-26.5 Score on a Scale
Standard Deviation 27.81
|
—
|
|
mm [Best]Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 6 (n=1745)
|
-29.8 Score on a Scale
Standard Deviation 29.06
|
—
|
|
mm [Best]Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 2 (n=355)
|
-20.5 Score on a Scale
Standard Deviation 24.60
|
—
|
|
mm [Best]Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 4 (n=355)
|
-27.3 Score on a Scale
Standard Deviation 28.62
|
—
|
|
mm [Best]Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 6 (n=355)
|
-31.2 Score on a Scale
Standard Deviation 28.22
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the participant global assessment of disease activity by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 2 (n=1056)
|
-21.0 Score on a Scale
Standard Deviation 23.25
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 4 (n=1056)
|
-26.3 Score on a Scale
Standard Deviation 25.27
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 6 (n=1056)
|
-31.4 Score on a Scale
Standard Deviation 27.38
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 2 (n=1061)
|
-20.8 Score on a Scale
Standard Deviation 24.98
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 4 (n=1061)
|
-26.7 Score on a Scale
Standard Deviation 27.63
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 6 (n=1061)
|
-28.8 Score on a Scale
Standard Deviation 28.63
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 2 (n=1097)
|
-21.2 Score on a Scale
Standard Deviation 25.38
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 4 (n=1097)
|
-27.0 Score on a Scale
Standard Deviation 28.19
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 6 (n=1097)
|
-30.3 Score on a Scale
Standard Deviation 29.13
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the participant global assessment of disease activity by the physician's expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 4 (n=325)
|
-23.4 Score on a Scale
Standard Deviation 27.22
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 6 (n=325)
|
-28.3 Score on a Scale
Standard Deviation 27.88
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 4 (n=966)
|
-26.5 Score on a Scale
Standard Deviation 27.25
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 2 (n=40)
|
-25.1 Score on a Scale
Standard Deviation 25.56
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 4 (n=40)
|
-22.4 Score on a Scale
Standard Deviation 24.52
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 6 (n=40)
|
-30.6 Score on a Scale
Standard Deviation 27.95
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 2 (n=325)
|
-17.3 Score on a Scale
Standard Deviation 24.53
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 2 (n=1932)
|
-21.4 Score on a Scale
Standard Deviation 24.36
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 4 (n=1932)
|
-27.3 Score on a Scale
Standard Deviation 27.08
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 6 (n=1932)
|
-31.0 Score on a Scale
Standard Deviation 28.16
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 2 (n=966)
|
-21.2 Score on a Scale
Standard Deviation 25.13
|
—
|
|
Mean Change From Baseline in Participant Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 6 (n=966)
|
-28.9 Score on a Scale
Standard Deviation 29.27
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The change from baseline in participant serum ESR was calculated by concomitant MTX dose (low \< 10mg/wk, medium \>= 10 to \< 15 mg/week, and high \>=15 mg/week) at study Month 2, Month 4, and Month 6.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Erythrocyte Sedimentation Rate (ESR) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 2 (n=1995)
|
-9.2 mm/h
Standard Deviation 17.85
|
—
|
|
Mean Change From Baseline in the Erythrocyte Sedimentation Rate (ESR) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 4 (n=1995)
|
-10.3 mm/h
Standard Deviation 19.03
|
—
|
|
Mean Change From Baseline in the Erythrocyte Sedimentation Rate (ESR) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 6 (n=1995)
|
-10.9 mm/h
Standard Deviation 20.43
|
—
|
|
Mean Change From Baseline in the Erythrocyte Sedimentation Rate (ESR) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 2 (n=142)
|
-9.4 mm/h
Standard Deviation 14.73
|
—
|
|
Mean Change From Baseline in the Erythrocyte Sedimentation Rate (ESR) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 4 (n=142)
|
-9.8 mm/h
Standard Deviation 18.98
|
—
|
|
Mean Change From Baseline in the Erythrocyte Sedimentation Rate (ESR) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 6 (n=142)
|
-9.2 mm/h
Standard Deviation 21.99
|
—
|
|
Mean Change From Baseline in the Erythrocyte Sedimentation Rate (ESR) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 2 (n=526)
|
-11.2 mm/h
Standard Deviation 17.91
|
—
|
|
Mean Change From Baseline in the Erythrocyte Sedimentation Rate (ESR) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 4 (n=526)
|
-11.5 mm/h
Standard Deviation 21.29
|
—
|
|
Mean Change From Baseline in the Erythrocyte Sedimentation Rate (ESR) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 6 (n=526)
|
-12.8 mm/h
Standard Deviation 22.52
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in participant serum ESR by concomitant DMARD background treatment was calculated at study Month 2, Month 4, and Month 6. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in ESR by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 2 (n=1681)
|
-9.8 mm/h
Standard Deviation 17.03
|
—
|
|
Mean Change From Baseline in ESR by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 4 (n=433)
|
-9.2 mm/h
Standard Deviation 20.60
|
—
|
|
Mean Change From Baseline in ESR by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 6 (n=433)
|
-10.9 mm/h
Standard Deviation 22.12
|
—
|
|
Mean Change From Baseline in ESR by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 2 (n=216)
|
-10.0 mm/h
Standard Deviation 20.15
|
—
|
|
Mean Change From Baseline in ESR by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 4 (n=216)
|
-9.9 mm/h
Standard Deviation 19.25
|
—
|
|
Mean Change From Baseline in ESR by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 6 (n=216)
|
-9.8 mm/h
Standard Deviation 22.15
|
—
|
|
Mean Change From Baseline in ESR by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 - Month 2 (n=150)
|
-10.3 mm/h
Standard Deviation 15.74
|
—
|
|
Mean Change From Baseline in ESR by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 -Month 4 (n=150)
|
-14.9 mm/h
Standard Deviation 23.30
|
—
|
|
Mean Change From Baseline in ESR by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 - Month 6 (n=150)
|
-11.9 mm/h
Standard Deviation 21.73
|
—
|
|
Mean Change From Baseline in ESR by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 2 (n=106)
|
-10.0 mm/h
Standard Deviation 18.88
|
—
|
|
Mean Change From Baseline in ESR by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 4 (n=106)
|
-8.7 mm/h
Standard Deviation 19.13
|
—
|
|
Mean Change From Baseline in ESR by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 6 (n=106)
|
-9.0 mm/h
Standard Deviation 20.65
|
—
|
|
Mean Change From Baseline in ESR by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 2 (n=303)
|
-7.6 mm/h
Standard Deviation 17.87
|
—
|
|
Mean Change From Baseline in ESR by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 4 (n=303)
|
-8.1 mm/h
Standard Deviation 20.40
|
—
|
|
Mean Change From Baseline in ESR by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 6 (n=303)
|
-8.3 mm/h
Standard Deviation 21.40
|
—
|
|
Mean Change From Baseline in ESR by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 4 (n=1681)
|
-10.9 mm/h
Standard Deviation 18.94
|
—
|
|
Mean Change From Baseline in ESR by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 6 (n=1681)
|
-11.6 mm/h
Standard Deviation 20.53
|
—
|
|
Mean Change From Baseline in ESR by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 2 (n=433)
|
-8.1 mm/h
Standard Deviation 19.27
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in serum ESR by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 2 (n=1202)
|
-9.3 mm/h
Standard Deviation 16.83
|
—
|
|
Mean Change From Baseline in ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 4 (n=1202)
|
-10.4 mm/h
Standard Deviation 18.58
|
—
|
|
Mean Change From Baseline in ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 6 (n=1202)
|
-10.7 mm/h
Standard Deviation 20.59
|
—
|
|
Mean Change From Baseline in ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 2 (n=2078)
|
-9.4 mm/h
Standard Deviation 18.28
|
—
|
|
Mean Change From Baseline in ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 4 (n=2078)
|
-10.1 mm/h
Standard Deviation 20.02
|
—
|
|
Mean Change From Baseline in ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 6 (n=2078)
|
-10.7 mm/h
Standard Deviation 21.36
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in participant serum ESR by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in ESR by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 2 (n=1129)
|
-10.0 mm/h
Standard Deviation 17.77
|
—
|
|
Mean Change From Baseline in ESR by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 4 (n=1129)
|
-11.5 mm/h
Standard Deviation 20.15
|
—
|
|
Mean Change From Baseline in ESR by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 6 (n=1129)
|
-12.0 mm/h
Standard Deviation 21.71
|
—
|
|
Mean Change From Baseline in ESR by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 2 (n=1176)
|
-9.0 mm/h
Standard Deviation 18.03
|
—
|
|
Mean Change From Baseline in ESR by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 4 (n=1176)
|
-9.6 mm/h
Standard Deviation 19.25
|
—
|
|
Mean Change From Baseline in ESR by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 6 (n=1176)
|
-10.3 mm/h
Standard Deviation 20.83
|
—
|
|
Mean Change From Baseline in ESR by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 2 (n=974)
|
-9.1 mm/h
Standard Deviation 17.42
|
—
|
|
Mean Change From Baseline in ESR by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 4 (n=974)
|
-9.5 mm/h
Standard Deviation 18.96
|
—
|
|
Mean Change From Baseline in ESR by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 6 (n=974)
|
-9.9 mm/h
Standard Deviation 20.61
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the participant serum ESR by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in ESR by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 2 (n=899)
|
-8.6 mm/h
Standard Deviation 17.77
|
—
|
|
Mean Change From Baseline in ESR by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 4 (n=899)
|
-10.6 mm/h
Standard Deviation 20.08
|
—
|
|
Mean Change From Baseline in ESR by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 6 (n=899)
|
-11.2 mm/h
Standard Deviation 21.35
|
—
|
|
Mean Change From Baseline in ESR by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 2 (n=764)
|
-9.1 mm/h
Standard Deviation 17.97
|
—
|
|
Mean Change From Baseline in ESR by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 4 (n=764)
|
-9.5 mm/h
Standard Deviation 19.60
|
—
|
|
Mean Change From Baseline in ESR by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 6 (n=764)
|
-9.4 mm/h
Standard Deviation 20.81
|
—
|
|
Mean Change From Baseline in ESR by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 2 (n=692)
|
-9.5 mm/h
Standard Deviation 17.69
|
—
|
|
Mean Change From Baseline in ESR by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 4 (n=692)
|
-10.2 mm/h
Standard Deviation 18.85
|
—
|
|
Mean Change From Baseline in ESR by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 6 (n=692)
|
-11.4 mm/h
Standard Deviation 21.47
|
—
|
|
Mean Change From Baseline in ESR by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 2 (n=924)
|
-10.2 mm/h
Standard Deviation 17.63
|
—
|
|
Mean Change From Baseline in ESR by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 4 (n=924)
|
-10.5 mm/h
Standard Deviation 19.37
|
—
|
|
Mean Change From Baseline in ESR by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 6 (n=924)
|
-10.9 mm/h
Standard Deviation 20.74
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in participant serum ESR by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. DAS28-ESR \> 5.1 = high disease activity, DAS28-ESR \< 3.2 to \< =5.1 = low disease activity, and DAS28-ESR \<2.6 = remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in ESR by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 2 (n=698)
|
-3.3 mm/h
Standard Deviation 11.24
|
—
|
|
Mean Change From Baseline in ESR by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 4 (n=698)
|
-2.2 mm/h
Standard Deviation 13.03
|
—
|
|
Mean Change From Baseline in ESR by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 6 (n=698)
|
-2.2 mm/h
Standard Deviation 13.83
|
—
|
|
Mean Change From Baseline in ESR by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 2 (n=2572)
|
-11.1 mm/h
Standard Deviation 18.76
|
—
|
|
Mean Change From Baseline in ESR by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 4 (n=2572)
|
-12.4 mm/h
Standard Deviation 20.36
|
—
|
|
Mean Change From Baseline in ESR by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 6 (n=2572)
|
-13.1 mm/h
Standard Deviation 22.09
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in participant serum ESR by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in ESR by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 2 (n=1026)
|
-8.6 mm/h
Standard Deviation 17.12
|
—
|
|
Mean Change From Baseline in ESR by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 4 (n=1026)
|
-9.2 mm/h
Standard Deviation 18.36
|
—
|
|
Mean Change From Baseline in ESR by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 6 (n=1026)
|
-9.7 mm/h
Standard Deviation 19.73
|
—
|
|
Mean Change From Baseline in ESR by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 2 (n=1081)
|
-9.7 mm/h
Standard Deviation 17.75
|
—
|
|
Mean Change From Baseline in ESR by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 4 (n=1081)
|
-10.3 mm/h
Standard Deviation 19.18
|
—
|
|
Mean Change From Baseline in ESR by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 6 (n=1081)
|
-10.3 mm/h
Standard Deviation 20.90
|
—
|
|
Mean Change From Baseline in ESR by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 2 (n=1127)
|
-9.8 mm/h
Standard Deviation 18.35
|
—
|
|
Mean Change From Baseline in ESR by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 4 (n=1127)
|
-11.1 mm/h
Standard Deviation 20.70
|
—
|
|
Mean Change From Baseline in ESR by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 6 (n=1127)
|
-12.2 mm/h
Standard Deviation 22.41
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in ESR by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in ESR by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 2 (n=1038)
|
-8.6 mm/h
Standard Deviation 16.79
|
—
|
|
Mean Change From Baseline in ESR by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 4 (n=1038)
|
-8.9 mm/h
Standard Deviation 17.67
|
—
|
|
Mean Change From Baseline in ESR by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 6 (n=1038)
|
-9.8 mm/h
Standard Deviation 20.33
|
—
|
|
Mean Change From Baseline in ESR by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 2 (n=1112)
|
-9.7 mm/h
Standard Deviation 18.17
|
—
|
|
Mean Change From Baseline in ESR by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 4 (n=1112)
|
-10.7 mm/h
Standard Deviation 20.44
|
—
|
|
Mean Change From Baseline in ESR by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 6 (n=1112)
|
-11.0 mm/h
Standard Deviation 20.64
|
—
|
|
Mean Change From Baseline in ESR by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 2 (n=1075)
|
-9.7 mm/h
Standard Deviation 18.37
|
—
|
|
Mean Change From Baseline in ESR by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 4 (n=1075)
|
-11.1 mm/h
Standard Deviation 20.21
|
—
|
|
Mean Change From Baseline in ESR by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 6 (n=1075)
|
-11.4 mm/h
Standard Deviation 22.30
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in participant serum ESR by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 4 (n=314)
|
-10.1 mm/h
Standard Deviation 18.24
|
—
|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 6 (n=314)
|
-9.9 mm/h
Standard Deviation 20.03
|
—
|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Currently smokes <0.5 packs/day - Month 2 (n=223)
|
-9.3 mm/h
Standard Deviation 17.51
|
—
|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Currently smokes <0.5 packs/day - Month 4 (n=223)
|
-9.4 mm/h
Standard Deviation 19.35
|
—
|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Currently smokes <0.5 pack/day - Month 6 (n=223)
|
-10.7 mm/h
Standard Deviation 22.22
|
—
|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 2 (n=397)
|
-8.0 mm/h
Standard Deviation 14.88
|
—
|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 4 (n=397)
|
-8.6 mm/h
Standard Deviation 18.01
|
—
|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 6 (n=397)
|
-8.0 mm/h
Standard Deviation 18.68
|
—
|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 2 (n=59)
|
-6.3 mm/h
Standard Deviation 12.82
|
—
|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 4 (n=59)
|
-4.8 mm/h
Standard Deviation 16.93
|
—
|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 6 (n=59)
|
-6.2 mm/h
Standard Deviation 20.00
|
—
|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 2 (n=423)
|
-9.1 mm/h
Standard Deviation 17.40
|
—
|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 4 (n=423)
|
-9.2 mm/h
Standard Deviation 18.24
|
—
|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Non-Smoker - Month 2 (n=1963)
|
-9.7 mm/h
Standard Deviation 18.40
|
—
|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Non-Smoker - Month 4 (n=1963)
|
-10.8 mm/h
Standard Deviation 20.04
|
—
|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Non-Smoker - Month 6 (n=1963)
|
-11.7 mm/h
Standard Deviation 21.57
|
—
|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 6 (n=423)
|
-10.1 mm/h
Standard Deviation 21.17
|
—
|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 2 (n=454)
|
-9.0 mm/h
Standard Deviation 16.61
|
—
|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 4 (n=454)
|
-9.8 mm/h
Standard Deviation 18.60
|
—
|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 6 (n=454)
|
-10.1 mm/h
Standard Deviation 18.73
|
—
|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 2 (n=418)
|
-8.2 mm/h
Standard Deviation 16.42
|
—
|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 4 (n=418)
|
-9.2 mm/h
Standard Deviation 19.44
|
—
|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 6 (n=418)
|
-7.6 mm/h
Standard Deviation 20.91
|
—
|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 2 (n=324)
|
-10.3 mm/h
Standard Deviation 18.11
|
—
|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 4 (n=324)
|
-10.6 mm/h
Standard Deviation 19.52
|
—
|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 6 (n=324)
|
-9.7 mm/h
Standard Deviation 20.95
|
—
|
|
Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 2 (n=314)
|
-8.4 mm/h
Standard Deviation 17.55
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in participant serum ESR by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in ESR by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 2 (n=106)
|
-5.6 mm/h
Standard Deviation 10.46
|
—
|
|
Mean Change From Baseline in ESR by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 4 (n=106)
|
-5.0 mm/h
Standard Deviation 10.87
|
—
|
|
Mean Change From Baseline in ESR by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 6 (n=106)
|
-4.7 mm/h
Standard Deviation 11.99
|
—
|
|
Mean Change From Baseline in ESR by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 2 (n=3174)
|
-9.5 mm/h
Standard Deviation 17.94
|
—
|
|
Mean Change From Baseline in ESR by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 4 (n=3174)
|
-10.4 mm/h
Standard Deviation 19.70
|
—
|
|
Mean Change From Baseline in ESR by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 6 (n=3174)
|
-10.9 mm/h
Standard Deviation 21.29
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: \<=1.5, \>1.5 to \<1.86, and \>=1.86.
The mean change from baseline in participant serum ESR by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in ESR by Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 4 (n=1212)
|
-11.2 mm/h
Standard Deviation 19.25
|
—
|
|
Mean Change From Baseline in ESR by Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 6 (n=1212)
|
-11.4 mm/h
Standard Deviation 21.53
|
—
|
|
Mean Change From Baseline in ESR by Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 2 (n=1212)
|
-10.1 mm/h
Standard Deviation 18.15
|
—
|
|
Mean Change From Baseline in ESR by Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 2 (n=1009)
|
-9.6 mm/h
Standard Deviation 18.27
|
—
|
|
Mean Change From Baseline in ESR by Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 4 (n=1009)
|
-11.3 mm/h
Standard Deviation 20.44
|
—
|
|
Mean Change From Baseline in ESR by Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 6 (n=1009)
|
-11.8 mm/h
Standard Deviation 21.58
|
—
|
|
Mean Change From Baseline in ESR by Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 2 (n=1054)
|
-8.2 mm/h
Standard Deviation 16.79
|
—
|
|
Mean Change From Baseline in ESR by Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 4 (n=1054)
|
-8.0 mm/h
Standard Deviation 18.73
|
—
|
|
Mean Change From Baseline in ESR by Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 6 (n=1054)
|
-8.9 mm/h
Standard Deviation 19.96
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in participant serum ESR by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in ESR by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 2 (n=1305)
|
-8.6 mm/h
Standard Deviation 17.45
|
—
|
|
Mean Change From Baseline in ESR by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 4 (n=1305)
|
-9.4 mm/h
Standard Deviation 19.02
|
—
|
|
Mean Change From Baseline in ESR by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 6 (n=1305)
|
-9.9 mm/h
Standard Deviation 20.85
|
—
|
|
Mean Change From Baseline in ESR by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 2 (n=1105)
|
-9.6 mm/h
Standard Deviation 18.39
|
—
|
|
Mean Change From Baseline in ESR by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 4 (n=1105)
|
-10.7 mm/h
Standard Deviation 20.44
|
—
|
|
Mean Change From Baseline in ESR by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 6 (n=1105)
|
-11.8 mm/h
Standard Deviation 22.27
|
—
|
|
Mean Change From Baseline in ESR by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 2 (n=850)
|
-10.2 mm/h
Standard Deviation 17.49
|
—
|
|
Mean Change From Baseline in ESR by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 4 (n=850)
|
-10.9 mm/h
Standard Deviation 19.13
|
—
|
|
Mean Change From Baseline in ESR by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 6 (n=850)
|
-10.6 mm/h
Standard Deviation 19.95
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in participant serum ESR by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in ESR by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 2 (n=1160)
|
-8.8 mm/h
Standard Deviation 18.10
|
—
|
|
Mean Change From Baseline in ESR by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 4 (n=1160)
|
-10.7 mm/h
Standard Deviation 19.43
|
—
|
|
Mean Change From Baseline in ESR by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 6 (n=1160)
|
-9.9 mm/h
Standard Deviation 21.87
|
—
|
|
Mean Change From Baseline in ESR by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 2 (n=1745)
|
-9.7 mm/h
Standard Deviation 17.65
|
—
|
|
Mean Change From Baseline in ESR by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 4 (n=1745)
|
-9.6 mm/h
Standard Deviation 19.76
|
—
|
|
Mean Change From Baseline in ESR by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 6 (n=1745)
|
-11.0 mm/h
Standard Deviation 20.90
|
—
|
|
Mean Change From Baseline in ESR by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 2 (n=355)
|
-9.7 mm/h
Standard Deviation 17.44
|
—
|
|
Mean Change From Baseline in ESR by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 4 (n=355)
|
-11.5 mm/h
Standard Deviation 18.81
|
—
|
|
Mean Change From Baseline in ESR by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 6 (n=355)
|
-12.0 mm/h
Standard Deviation 19.62
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in participant serum ESR by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in ESR by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 2 (n=1056)
|
-8.9 mm/h
Standard Deviation 18.47
|
—
|
|
Mean Change From Baseline in ESR by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 4 (n=1056)
|
-9.2 mm/h
Standard Deviation 19.18
|
—
|
|
Mean Change From Baseline in ESR by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 6 (n=1056)
|
-9.5 mm/h
Standard Deviation 20.50
|
—
|
|
Mean Change From Baseline in ESR by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 2 (n=1061)
|
-9.8 mm/h
Standard Deviation 16.19
|
—
|
|
Mean Change From Baseline in ESR by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 4 (n=1061)
|
-10.9 mm/h
Standard Deviation 19.55
|
—
|
|
Mean Change From Baseline in ESR by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 6 (n=1061)
|
-11.5 mm/h
Standard Deviation 21.16
|
—
|
|
Mean Change From Baseline in ESR by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 2 (n=1097)
|
-9.2 mm/h
Standard Deviation 17.96
|
—
|
|
Mean Change From Baseline in ESR by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 4 (n=1097)
|
-10.0 mm/h
Standard Deviation 19.33
|
—
|
|
Mean Change From Baseline in ESR by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 6 (n=1097)
|
-10.9 mm/h
Standard Deviation 21.02
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in participant serum ESR by the physician's expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 2 (n=966)
|
-9.4 mm/h
Standard Deviation 17.70
|
—
|
|
Mean Change From Baseline in ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 4 (n=966)
|
-10.0 mm/h
Standard Deviation 19.15
|
—
|
|
Mean Change From Baseline in ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 6 (n=966)
|
-10.9 mm/h
Standard Deviation 21.33
|
—
|
|
Mean Change From Baseline in ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 2 (n=40)
|
-16.9 mm/h
Standard Deviation 20.16
|
—
|
|
Mean Change From Baseline in ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 4 (n=40)
|
-17.0 mm/h
Standard Deviation 23.02
|
—
|
|
Mean Change From Baseline in ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 6 (n=40)
|
-13.0 mm/h
Standard Deviation 26.66
|
—
|
|
Mean Change From Baseline in ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 2 (n=325)
|
-8.8 mm/h
Standard Deviation 19.09
|
—
|
|
Mean Change From Baseline in ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 4 (n=325)
|
-10.1 mm/h
Standard Deviation 20.39
|
—
|
|
Mean Change From Baseline in ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 6 (n=325)
|
-11.6 mm/h
Standard Deviation 21.77
|
—
|
|
Mean Change From Baseline in ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 2 (n=1932)
|
-9.3 mm/h
Standard Deviation 17.54
|
—
|
|
Mean Change From Baseline in ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 4 (n=1932)
|
-10.3 mm/h
Standard Deviation 19.45
|
—
|
|
Mean Change From Baseline in ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 6 (n=1932)
|
-10.5 mm/h
Standard Deviation 20.73
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The change from baseline in participant serum CRP was calculated by concomitant MTX dose (low \< 10mg/wk, medium \>= 10 to \< 15 mg/week, and high \>=15 mg/week) at study Month 2, Month 4, and Month 6.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in C-Reactive Protein (CRP) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 6 (n=1967)
|
-5.76 mg/L
Standard Deviation 19.045
|
—
|
|
Mean Change From Baseline in C-Reactive Protein (CRP) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 2 (n=138)
|
-6.43 mg/L
Standard Deviation 15.483
|
—
|
|
Mean Change From Baseline in C-Reactive Protein (CRP) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 4 (n=138)
|
-4.97 mg/L
Standard Deviation 19.260
|
—
|
|
Mean Change From Baseline in C-Reactive Protein (CRP) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 6 (n=138)
|
-6.61 mg/L
Standard Deviation 17.632
|
—
|
|
Mean Change From Baseline in C-Reactive Protein (CRP) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 2 (n=519)
|
-7.14 mg/L
Standard Deviation 17.591
|
—
|
|
Mean Change From Baseline in C-Reactive Protein (CRP) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 4 (n=519)
|
-6.54 mg/L
Standard Deviation 20.221
|
—
|
|
Mean Change From Baseline in C-Reactive Protein (CRP) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 6 (n=519)
|
-5.93 mg/L
Standard Deviation 23.755
|
—
|
|
Mean Change From Baseline in C-Reactive Protein (CRP) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 2 (n=1967)
|
-5.52 mg/L
Standard Deviation 18.452
|
—
|
|
Mean Change From Baseline in C-Reactive Protein (CRP) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 4 (n=1967)
|
-5.46 mg/L
Standard Deviation 18.921
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in participant serum CRP by concomitant DMARD background treatment was calculated at study Month 2, Month 4, and Month 6. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in CRP by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 2 (n=1662)
|
-6.02 mg/L
Standard Deviation 16.365
|
—
|
|
Mean Change From Baseline in CRP by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 6 (n=1662)
|
-5.91 mg/L
Standard Deviation 19.101
|
—
|
|
Mean Change From Baseline in CRP by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 4 (n=211)
|
-3.32 mg/L
Standard Deviation 19.341
|
—
|
|
Mean Change From Baseline in CRP by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 4 (n=1662)
|
-5.74 mg/L
Standard Deviation 18.459
|
—
|
|
Mean Change From Baseline in CRP by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 2 (n=424)
|
-6.14 mg/L
Standard Deviation 16.979
|
—
|
|
Mean Change From Baseline in CRP by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 4 (n=424)
|
-5.07 mg/L
Standard Deviation 21.648
|
—
|
|
Mean Change From Baseline in CRP by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 6 (n=424)
|
-6.43 mg/L
Standard Deviation 18.324
|
—
|
|
Mean Change From Baseline in CRP by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 2 (n=211)
|
-2.56 mg/L
Standard Deviation 22.236
|
—
|
|
Mean Change From Baseline in CRP by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 6 (n=211)
|
-2.37 mg/L
Standard Deviation 16.441
|
—
|
|
Mean Change From Baseline in CRP by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 - Month 2 (n=147)
|
-7.57 mg/L
Standard Deviation 22.433
|
—
|
|
Mean Change From Baseline in CRP by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 -Month 4 (n=147)
|
-9.61 mg/L
Standard Deviation 22.126
|
—
|
|
Mean Change From Baseline in CRP by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 - Month 6 (n=147)
|
-9.54 mg/L
Standard Deviation 22.444
|
—
|
|
Mean Change From Baseline in CRP by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 2 (n=104)
|
-4.42 mg/L
Standard Deviation 28.394
|
—
|
|
Mean Change From Baseline in CRP by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 4 (n=104)
|
-4.49 mg/L
Standard Deviation 16.258
|
—
|
|
Mean Change From Baseline in CRP by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 6 (n=104)
|
-3.62 mg/L
Standard Deviation 36.080
|
—
|
|
Mean Change From Baseline in CRP by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 2 (n=301)
|
-3.90 mg/L
Standard Deviation 16.817
|
—
|
|
Mean Change From Baseline in CRP by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 4 (n=301)
|
-4.70 mg/L
Standard Deviation 17.356
|
—
|
|
Mean Change From Baseline in CRP by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 6 (n=301)
|
-4.08 mg/L
Standard Deviation 19.620
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in serum CRP by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 2 (n=1187)
|
-5.14 mg/L
Standard Deviation 15.017
|
—
|
|
Mean Change From Baseline in CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 4 (n=1187)
|
-4.90 mg/L
Standard Deviation 15.643
|
—
|
|
Mean Change From Baseline in CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 6 (n=1187)
|
-5.00 mg/L
Standard Deviation 18.391
|
—
|
|
Mean Change From Baseline in CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 2 (n=2048)
|
-6.04 mg/L
Standard Deviation 19.355
|
—
|
|
Mean Change From Baseline in CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 4 (n=2048)
|
-5.98 mg/L
Standard Deviation 20.850
|
—
|
|
Mean Change From Baseline in CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 6 (n=2048)
|
-6.20 mg/L
Standard Deviation 20.738
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in participant serum CRP by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in CRP by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 2 (n=1118)
|
-6.38 mg/L
Standard Deviation 18.525
|
—
|
|
Mean Change From Baseline in CRP by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 4 (n=1118)
|
-6.23 mg/L
Standard Deviation 20.809
|
—
|
|
Mean Change From Baseline in CRP by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 6 (n=1118)
|
-6.06 mg/L
Standard Deviation 21.514
|
—
|
|
Mean Change From Baseline in CRP by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 2 (n=1158)
|
-5.20 mg/L
Standard Deviation 17.550
|
—
|
|
Mean Change From Baseline in CRP by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 4 (n=1158)
|
-4.89 mg/L
Standard Deviation 18.155
|
—
|
|
Mean Change From Baseline in CRP by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 6 (n=1158)
|
-5.54 mg/L
Standard Deviation 18.247
|
—
|
|
Mean Change From Baseline in CRP by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 2 (n=958)
|
-5.56 mg/L
Standard Deviation 17.533
|
—
|
|
Mean Change From Baseline in CRP by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 4 (n=958)
|
-5.69 mg/L
Standard Deviation 18.158
|
—
|
|
Mean Change From Baseline in CRP by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 6 (n=958)
|
-5.69 mg/L
Standard Deviation 19.959
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the participant serum CRP by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in CRP by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 2 (n=756)
|
-6.42 mg/L
Standard Deviation 20.069
|
—
|
|
Mean Change From Baseline in CRP by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 2 (n=885)
|
-5.84 mg/L
Standard Deviation 18.067
|
—
|
|
Mean Change From Baseline in CRP by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 4 (n=885)
|
-5.40 mg/L
Standard Deviation 21.661
|
—
|
|
Mean Change From Baseline in CRP by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 6 (n=885)
|
-6.03 mg/L
Standard Deviation 21.956
|
—
|
|
Mean Change From Baseline in CRP by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 4 (n=756)
|
-6.23 mg/L
Standard Deviation 19.018
|
—
|
|
Mean Change From Baseline in CRP by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 6 (n=756)
|
-6.15 mg/L
Standard Deviation 20.592
|
—
|
|
Mean Change From Baseline in CRP by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 2 (n=681)
|
-4.73 mg/L
Standard Deviation 15.933
|
—
|
|
Mean Change From Baseline in CRP by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 4 (n=681)
|
-4.49 mg/L
Standard Deviation 18.010
|
—
|
|
Mean Change From Baseline in CRP by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 6 (n=681)
|
-5.15 mg/L
Standard Deviation 16.892
|
—
|
|
Mean Change From Baseline in CRP by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 2 (n=912)
|
-5.73 mg/L
Standard Deviation 17.183
|
—
|
|
Mean Change From Baseline in CRP by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 4 (n=912)
|
-6.05 mg/L
Standard Deviation 17.284
|
—
|
|
Mean Change From Baseline in CRP by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 6 (n=912)
|
-5.63 mg/L
Standard Deviation 19.402
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in participant serum CRP by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. DAS28-ESR scores of \> 3.2 to \<=5.1 indicate moderate disease activity and DAS28-ESR scores of \> 5.1 indicate high disease activity.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in CRP by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 2 (n=687)
|
-3.07 mg/L
Standard Deviation 11.053
|
—
|
|
Mean Change From Baseline in CRP by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 4 (n=687)
|
-1.61 mg/L
Standard Deviation 13.582
|
—
|
|
Mean Change From Baseline in CRP by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 6 (n=687)
|
-1.57 mg/L
Standard Deviation 13.418
|
—
|
|
Mean Change From Baseline in CRP by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 2 (n=2538)
|
-6.43 mg/L
Standard Deviation 19.287
|
—
|
|
Mean Change From Baseline in CRP by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 4 (n=2538)
|
-6.67 mg/L
Standard Deviation 20.241
|
—
|
|
Mean Change From Baseline in CRP by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 6 (n=2538)
|
-6.89 mg/L
Standard Deviation 21.215
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in participant serum CRP by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in CRP by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 2 (n=1025)
|
-5.18 mg/L
Standard Deviation 16.961
|
—
|
|
Mean Change From Baseline in CRP by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 4 (n=1025)
|
-4.63 mg/L
Standard Deviation 18.781
|
—
|
|
Mean Change From Baseline in CRP by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 6 (n=1025)
|
-5.19 mg/L
Standard Deviation 18.356
|
—
|
|
Mean Change From Baseline in CRP by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 2 (n=1079)
|
-6.12 mg/L
Standard Deviation 15.703
|
—
|
|
Mean Change From Baseline in CRP by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 4 (n=1079)
|
-5.89 mg/L
Standard Deviation 17.219
|
—
|
|
Mean Change From Baseline in CRP by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 6 (n=1079)
|
-5.46 mg/L
Standard Deviation 21.063
|
—
|
|
Mean Change From Baseline in CRP by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 2 (n=1125)
|
-5.85 mg/L
Standard Deviation 20.488
|
—
|
|
Mean Change From Baseline in CRP by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 4 (n=1125)
|
-6.21 mg/L
Standard Deviation 21.056
|
—
|
|
Mean Change From Baseline in CRP by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 6 (n=1125)
|
-6.59 mg/L
Standard Deviation 20.170
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in CRP by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in CRP by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 6 (n=1027)
|
-5.03 mg/L
Standard Deviation 18.512
|
—
|
|
Mean Change From Baseline in CRP by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 2 (n=1101)
|
-5.95 mg/L
Standard Deviation 17.423
|
—
|
|
Mean Change From Baseline in CRP by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 4 (n=1101)
|
-5.73 mg/L
Standard Deviation 18.955
|
—
|
|
Mean Change From Baseline in CRP by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 2 (n=1027)
|
-5.16 mg/L
Standard Deviation 17.703
|
—
|
|
Mean Change From Baseline in CRP by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 4 (n=1027)
|
-4.79 mg/L
Standard Deviation 19.454
|
—
|
|
Mean Change From Baseline in CRP by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 6 (n=1101)
|
-5.60 mg/L
Standard Deviation 18.699
|
—
|
|
Mean Change From Baseline in CRP by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 2 (n=1070)
|
-6.00 mg/L
Standard Deviation 18.651
|
—
|
|
Mean Change From Baseline in CRP by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 4 (n=1070)
|
-6.22 mg/L
Standard Deviation 19.067
|
—
|
|
Mean Change From Baseline in CRP by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 6 (n=1070)
|
-6.60 mg/L
Standard Deviation 22.345
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in participant serum CRP by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Non-Smoker - Month 2 (n=1941)
|
-6.00 mg/L
Standard Deviation 18.946
|
—
|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Non-Smoker - Month 4 (n=1941)
|
-5.96 mg/L
Standard Deviation 20.052
|
—
|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Non-Smoker - Month 6 (n=1941)
|
-6.27 mg/L
Standard Deviation 21.278
|
—
|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 2 (n=318)
|
-5.33 mg/L
Standard Deviation 13.490
|
—
|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 4 (n=318)
|
-4.42 mg/L
Standard Deviation 18.329
|
—
|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 6 (n=318)
|
-3.70 mg/L
Standard Deviation 16.922
|
—
|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 2 (n=312)
|
-5.88 mg/L
Standard Deviation 19.794
|
—
|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 4 (n=312)
|
-6.50 mg/L
Standard Deviation 17.869
|
—
|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 6 (n=312)
|
-7.38 mg/L
Standard Deviation 19.301
|
—
|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes <0.5 packs/day - Month 2 (n=218)
|
-4.28 mg/L
Standard Deviation 16.141
|
—
|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes <0.5 packs/day - Month 4 (n=218)
|
-4.85 mg/L
Standard Deviation 18.384
|
—
|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes <0.5 pack/day - Month 6 (n=218)
|
-4.72 mg/L
Standard Deviation 15.013
|
—
|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 2 (n=388)
|
-5.61 mg/L
Standard Deviation 13.870
|
—
|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 4 (n=388)
|
-4.88 mg/L
Standard Deviation 15.045
|
—
|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 6 (n=388)
|
-4.57 mg/L
Standard Deviation 18.217
|
—
|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 2 (n=58)
|
-3.44 mg/L
Standard Deviation 21.229
|
—
|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 4 (n=58)
|
-1.86 mg/L
Standard Deviation 23.322
|
—
|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 6 (n=58)
|
-2.76 mg/L
Standard Deviation 19.927
|
—
|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 2 (n=418)
|
-6.13 mg/L
Standard Deviation 18.761
|
—
|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 4 (n=418)
|
-5.91 mg/L
Standard Deviation 18.169
|
—
|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 6 (n=418)
|
-6.75 mg/L
Standard Deviation 18.752
|
—
|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 2 (n=450)
|
-4.73 mg/L
Standard Deviation 13.845
|
—
|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 4 (n=450)
|
-4.63 mg/L
Standard Deviation 16.089
|
—
|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 6 (n=450)
|
-4.60 mg/L
Standard Deviation 15.440
|
—
|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 2 (n=405)
|
-4.92 mg/L
Standard Deviation 15.558
|
—
|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 4 (n=405)
|
-4.40 mg/L
Standard Deviation 18.166
|
—
|
|
Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 6 (n=405)
|
-3.48 mg/L
Standard Deviation 18.229
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in participant serum CRP by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in CRP by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 2 (n=105)
|
-2.92 mg/L
Standard Deviation 10.633
|
—
|
|
Mean Change From Baseline in CRP by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 4 (n=105)
|
-2.74 mg/L
Standard Deviation 11.237
|
—
|
|
Mean Change From Baseline in CRP by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 6 (n=105)
|
-3.16 mg/L
Standard Deviation 10.453
|
—
|
|
Mean Change From Baseline in CRP by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 2 (n=3130)
|
-5.81 mg/L
Standard Deviation 18.078
|
—
|
|
Mean Change From Baseline in CRP by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 4 (n=3130)
|
-5.68 mg/L
Standard Deviation 19.314
|
—
|
|
Mean Change From Baseline in CRP by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 6 (n=3130)
|
-5.85 mg/L
Standard Deviation 20.146
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: \<=1.5, \>1.5 to \<1.86, and \>=1.86.
The mean change from baseline in participant serum CRP by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in CRP by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 2 (n=995)
|
-6.61 mg/L
Standard Deviation 18.586
|
—
|
|
Mean Change From Baseline in CRP by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 2 (n=1201)
|
-5.83 mg/L
Standard Deviation 15.963
|
—
|
|
Mean Change From Baseline in CRP by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 4 (n=1201)
|
-5.58 mg/L
Standard Deviation 17.902
|
—
|
|
Mean Change From Baseline in CRP by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 6 (n=1201)
|
-5.83 mg/L
Standard Deviation 17.496
|
—
|
|
Mean Change From Baseline in CRP by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 4 (n=995)
|
-6.66 mg/L
Standard Deviation 21.059
|
—
|
|
Mean Change From Baseline in CRP by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 6 (n=995)
|
-6.47 mg/L
Standard Deviation 22.984
|
—
|
|
Mean Change From Baseline in CRP by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 2 (n=1034)
|
-4.69 mg/L
Standard Deviation 19.286
|
—
|
|
Mean Change From Baseline in CRP by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 4 (n=1034)
|
-4.51 mg/L
Standard Deviation 18.487
|
—
|
|
Mean Change From Baseline in CRP by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 6 (n=1034)
|
-5.00 mg/L
Standard Deviation 19.364
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in participant serum CRP by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in CRP by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 2 (n=1284)
|
-5.17 mg/L
Standard Deviation 17.628
|
—
|
|
Mean Change From Baseline in CRP by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 4 (n=1284)
|
-5.29 mg/L
Standard Deviation 17.491
|
—
|
|
Mean Change From Baseline in CRP by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 6 (n=1284)
|
-5.77 mg/L
Standard Deviation 20.401
|
—
|
|
Mean Change From Baseline in CRP by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 2 (n=1094)
|
-5.60 mg/L
Standard Deviation 19.412
|
—
|
|
Mean Change From Baseline in CRP by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 4 (n=1094)
|
-5.58 mg/L
Standard Deviation 20.544
|
—
|
|
Mean Change From Baseline in CRP by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 6 (n=1094)
|
-5.65 mg/L
Standard Deviation 20.715
|
—
|
|
Mean Change From Baseline in CRP by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 2 (n=837)
|
-6.71 mg/L
Standard Deviation 16.262
|
—
|
|
Mean Change From Baseline in CRP by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 4 (n=837)
|
-6.03 mg/L
Standard Deviation 19.794
|
—
|
|
Mean Change From Baseline in CRP by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 6 (n=837)
|
-5.96 mg/L
Standard Deviation 18.132
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in participant serum CRP by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in CRP by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 2 (n=1147)
|
-5.40 mg/L
Standard Deviation 16.834
|
—
|
|
Mean Change From Baseline in CRP by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 4 (n=1147)
|
-5.53 mg/L
Standard Deviation 18.865
|
—
|
|
Mean Change From Baseline in CRP by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 6 (n=1147)
|
-6.38 mg/L
Standard Deviation 18.656
|
—
|
|
Mean Change From Baseline in CRP by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 2 (n=1717)
|
-5.95 mg/L
Standard Deviation 18.516
|
—
|
|
Mean Change From Baseline in CRP by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 4 (n=1717)
|
-5.59 mg/L
Standard Deviation 19.658
|
—
|
|
Mean Change From Baseline in CRP by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 6 (n=1717)
|
-5.42 mg/L
Standard Deviation 20.802
|
—
|
|
Mean Change From Baseline in CRP by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 2 (n=351)
|
-5.58 mg/L
Standard Deviation 18.496
|
—
|
|
Mean Change From Baseline in CRP by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 4 (n=351)
|
-5.68 mg/L
Standard Deviation 17.691
|
—
|
|
Mean Change From Baseline in CRP by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 6 (n=351)
|
-5.60 mg/L
Standard Deviation 19.623
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in participant serum CRP by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in CRP by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 4 (n=1043)
|
-5.51 mg/L
Standard Deviation 19.219
|
—
|
|
Mean Change From Baseline in CRP by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 2 (n=1043)
|
-5.61 mg/L
Standard Deviation 17.530
|
—
|
|
Mean Change From Baseline in CRP by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 6 (n=1043)
|
-6.01 mg/L
Standard Deviation 17.911
|
—
|
|
Mean Change From Baseline in CRP by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 2 (n=1049)
|
-5.31 mg/L
Standard Deviation 18.054
|
—
|
|
Mean Change From Baseline in CRP by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 4 (n=1049)
|
-5.24 mg/L
Standard Deviation 20.441
|
—
|
|
Mean Change From Baseline in CRP by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 6 (n=1049)
|
-5.49 mg/L
Standard Deviation 21.234
|
—
|
|
Mean Change From Baseline in CRP by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 2 (n=1077)
|
-6.18 mg/L
Standard Deviation 18.134
|
—
|
|
Mean Change From Baseline in CRP by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 4 (n=1077)
|
-5.92 mg/L
Standard Deviation 17.615
|
—
|
|
Mean Change From Baseline in CRP by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 6 (n=1077)
|
-5.81 mg/L
Standard Deviation 20.194
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in participant serum CRP by the physician's expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 2 (n=40)
|
-12.35 mg/L
Standard Deviation 19.948
|
—
|
|
Mean Change From Baseline in CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 4 (n=40)
|
-11.02 mg/L
Standard Deviation 23.210
|
—
|
|
Mean Change From Baseline in CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 6 (n=40)
|
-11.41 mg/L
Standard Deviation 20.392
|
—
|
|
Mean Change From Baseline in CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 2 (n=313)
|
-6.74 mg/L
Standard Deviation 19.737
|
—
|
|
Mean Change From Baseline in CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 4 (n=313)
|
-8.72 mg/L
Standard Deviation 20.915
|
—
|
|
Mean Change From Baseline in CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 6 (n=313)
|
-8.97 mg/L
Standard Deviation 22.089
|
—
|
|
Mean Change From Baseline in CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 2 (n=1906)
|
-5.82 mg/L
Standard Deviation 19.413
|
—
|
|
Mean Change From Baseline in CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 4 (n=1906)
|
-5.70 mg/L
Standard Deviation 19.519
|
—
|
|
Mean Change From Baseline in CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 6 (n=1906)
|
-5.86 mg/L
Standard Deviation 20.553
|
—
|
|
Mean Change From Baseline in CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 2 (n=959)
|
-4.80 mg/L
Standard Deviation 13.488
|
—
|
|
Mean Change From Baseline in CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 4 (n=959)
|
-4.13 mg/L
Standard Deviation 17.227
|
—
|
|
Mean Change From Baseline in CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 6 (n=959)
|
-4.32 mg/L
Standard Deviation 17.589
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in physician global assessment of disease activity was calculated by concomitant MTX dose (low \< 10mg/wk, medium \>= 10 to \< 15 mg/week, and high \>=15 mg/week) at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 2 (n=142)
|
-24.6 Score on a Scale
Standard Deviation 19.80
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 4 (n=142)
|
-32.1 Score on a Scale
Standard Deviation 21.50
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 6 (n=142)
|
-35.8 Score on a Scale
Standard Deviation 22.02
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 2 (n=523)
|
-25.9 Score on a Scale
Standard Deviation 21.29
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 4 (n=523)
|
-34.4 Score on a Scale
Standard Deviation 21.19
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 6 (n=523)
|
-38.2 Score on a Scale
Standard Deviation 22.63
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 2 (n=1987)
|
-24.1 Score on a Scale
Standard Deviation 20.53
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 4 (n=1987)
|
-32.9 Score on a Scale
Standard Deviation 21.47
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 6 (n=1987)
|
-37.3 Score on a Scale
Standard Deviation 22.93
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the physician global assessment of disease by concomitant DMARD background treatment was evaluated at Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 - Month 6 (n=149)
|
-39.7 Score on a Scale
Standard Deviation 22.46
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 - Month 2 (n=149)
|
-25.1 Score on a Scale
Standard Deviation 20.53
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 -Month 4 (n=149)
|
-34.5 Score on a Scale
Standard Deviation 20.87
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 2 (n=105)
|
-26.1 Score on a Scale
Standard Deviation 21.63
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 4 (n=105)
|
-33.5 Score on a Scale
Standard Deviation 21.17
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 6 (n=105)
|
-35.7 Score on a Scale
Standard Deviation 22.58
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 2 (n=302)
|
-25.4 Score on a Scale
Standard Deviation 21.24
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 4 (n=302)
|
-33.3 Score on a Scale
Standard Deviation 22.52
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 6 (n=302)
|
-37.3 Score on a Scale
Standard Deviation 23.02
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 2 (n=1674)
|
-24.7 Score on a Scale
Standard Deviation 20.42
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 4 (n=1674)
|
-33.0 Score on a Scale
Standard Deviation 21.63
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 6 (n=1674)
|
-36.5 Score on a Scale
Standard Deviation 23.22
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 2 (n=432)
|
-23.5 Score on a Scale
Standard Deviation 21.44
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 4 (n=432)
|
-33.5 Score on a Scale
Standard Deviation 21.15
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 6 (n=432)
|
-40.5 Score on a Scale
Standard Deviation 21.00
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 2 (n=215)
|
-23.9 Score on a Scale
Standard Deviation 20.91
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 4 (n=215)
|
-31.8 Score on a Scale
Standard Deviation 21.43
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 6 (n=215)
|
-37.1 Score on a Scale
Standard Deviation 22.84
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the physician global assessment of disease activity by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 2 (n=1197)
|
-23.6 Score on a Scale
Standard Deviation 20.09
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 4 (n=1197)
|
-32.3 Score on a Scale
Standard Deviation 21.55
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 6 (n=1197)
|
-35.9 Score on a Scale
Standard Deviation 23.12
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 2 (n=2069)
|
-25.0 Score on a Scale
Standard Deviation 21.08
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 4 (n=2069)
|
-33.3 Score on a Scale
Standard Deviation 21.66
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 6 (n=2069)
|
-37.8 Score on a Scale
Standard Deviation 22.77
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the physician global assessment of disease activity score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 6 (n=1124)
|
-36.1 Score on a Scale
Standard Deviation 23.85
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 2 (n=1124)
|
-24.7 Score on a Scale
Standard Deviation 20.96
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 4 (n=1124)
|
-32.8 Score on a Scale
Standard Deviation 22.34
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 2 (n=1171)
|
-24.5 Score on a Scale
Standard Deviation 21.20
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 4 (n=1171)
|
-32.8 Score on a Scale
Standard Deviation 20.79
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 6 (n=1171)
|
-37.7 Score on a Scale
Standard Deviation 21.69
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 2 (n=970)
|
-24.2 Score on a Scale
Standard Deviation 19.89
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 4 (n=970)
|
-33.2 Score on a Scale
Standard Deviation 21.91
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 6 (n=970)
|
-37.6 Score on a Scale
Standard Deviation 23.24
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the physician global assessment of disease activity by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The physician global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 2 (n=895)
|
-23.5 Score on a Scale
Standard Deviation 21.06
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 4 (n=895)
|
-31.7 Score on a Scale
Standard Deviation 22.44
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 6 (n=895)
|
-35.3 Score on a Scale
Standard Deviation 23.98
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 2 (n=761)
|
-25.0 Score on a Scale
Standard Deviation 20.76
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 4 (n=761)
|
-33.4 Score on a Scale
Standard Deviation 21.79
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 6 (n=761)
|
-37.5 Score on a Scale
Standard Deviation 22.13
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 2 (n=688)
|
-23.6 Score on a Scale
Standard Deviation 2128
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 4 (n=688)
|
-32.4 Score on a Scale
Standard Deviation 21.00
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 6 (n=688)
|
-36.7 Score on a Scale
Standard Deviation 22.90
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 2 (n=921)
|
-25.7 Score on a Scale
Standard Deviation 19.92
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 4 (n=921)
|
-34.2 Score on a Scale
Standard Deviation 21.10
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 6 (n=921)
|
-38.7 Score on a Scale
Standard Deviation 22.39
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the physician global assessment of disease activity by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 2 (n=696)
|
-21.3 Score on a Scale
Standard Deviation 19.24
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 4 (n=696)
|
-27.4 Score on a Scale
Standard Deviation 20.01
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 6 (n=696)
|
-30.5 Score on a Scale
Standard Deviation 20.35
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 2 (n=2560)
|
-25.4 Score on a Scale
Standard Deviation 21.00
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 4 (n=2560)
|
-34.4 Score on a Scale
Standard Deviation 21.81
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 6 (n=2560)
|
-38.9 Score on a Scale
Standard Deviation 23.24
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the physician global assessment of disease activity by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 2 (n=1023)
|
-21.9 Score on a Scale
Standard Deviation 20.57
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 4 (n=1023)
|
-29.9 Score on a Scale
Standard Deviation 21.63
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 6 (n=1023)
|
-34.2 Score on a Scale
Standard Deviation 22.90
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 2 (n=1077)
|
-23.9 Score on a Scale
Standard Deviation 20.35
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 4 (n=1077)
|
-32.4 Score on a Scale
Standard Deviation 21.51
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 6 (n=1077)
|
-36.5 Score on a Scale
Standard Deviation 22.72
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 2 (n=1120)
|
-27.5 Score on a Scale
Standard Deviation 20.91
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 4 (n=1120)
|
-36.3 Score on a Scale
Standard Deviation 21.17
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 6 (n=1120)
|
-40.5 Score on a Scale
Standard Deviation 22.58
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR or at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the physician global assessment of disease activity by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 2 (n=1035)
|
-21.6 Score on a Scale
Standard Deviation 20.82
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 4 (n=1035)
|
-30.4 Score on a Scale
Standard Deviation 22.23
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 6 (n=1035)
|
-34.6 Score on a Scale
Standard Deviation 23.64
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 2 (n=1105)
|
-24.6 Score on a Scale
Standard Deviation 20.60
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 4 (n=1105)
|
-33.0 Score on a Scale
Standard Deviation 21.29
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 6 (n=1105)
|
-36.7 Score on a Scale
Standard Deviation 22.92
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 2 (n=1071)
|
-27.1 Score on a Scale
Standard Deviation 20.62
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 4 (n=1071)
|
-35.2 Score on a Scale
Standard Deviation 21.23
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 6 (n=1071)
|
-40.2 Score on a Scale
Standard Deviation 21.96
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the physician global assessment of disease activity by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes <0.5 packs/day - Month 4 (n=222)
|
-31.0 Score on a Scale
Standard Deviation 22.71
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Non-Smoker - Month 2 (n=1954)
|
-25.0 Score on a Scale
Standard Deviation 20.86
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Non-Smoker - Month 4 (n=1954)
|
-33.9 Score on a Scale
Standard Deviation 21.26
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Non-Smoker - Month 6 (n=1954)
|
-38.3 Score on a Scale
Standard Deviation 22.38
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 2 (n=323)
|
-26.5 Score on a Scale
Standard Deviation 19.97
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 4 (n=323)
|
-34.3 Score on a Scale
Standard Deviation 21.45
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 6 (n=323)
|
-38.7 Score on a Scale
Standard Deviation 21.91
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 2 (n=313)
|
-25.3 Score on a Scale
Standard Deviation 20.78
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 4 (n=313)
|
-33.1 Score on a Scale
Standard Deviation 21.79
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 6 (n=313)
|
-37.1 Score on a Scale
Standard Deviation 24.62
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes <0.5 packs/day - Month 2 (n=222)
|
-22.0 Score on a Scale
Standard Deviation 19.85
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes <0.5 pack/day - Month 6 (n=222)
|
-34.8 Score on a Scale
Standard Deviation 24.11
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 2 (n=395)
|
-21.6 Score on a Scale
Standard Deviation 20.33
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 4 (n=395)
|
-28.6 Score on a Scale
Standard Deviation 22.11
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 6 (n=395)
|
-31.6 Score on a Scale
Standard Deviation 23.62
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 2 (n=59)
|
-22.7 Score on a Scale
Standard Deviation 24.16
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 4 (n=59)
|
-28.9 Score on a Scale
Standard Deviation 22.61
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 6 (n=59)
|
-34.2 Score on a Scale
Standard Deviation 21.29
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 2 (n=422)
|
-24.8 Score on a Scale
Standard Deviation 20.94
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 4 (n=422)
|
-32.8 Score on a Scale
Standard Deviation 22.77
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 6 (n=422)
|
-36.7 Score on a Scale
Standard Deviation 24.61
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 2 (n=451)
|
-23.2 Score on a Scale
Standard Deviation 19.99
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 4 (n=451)
|
-31.5 Score on a Scale
Standard Deviation 20.84
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 6 (n=451)
|
-34.8 Score on a Scale
Standard Deviation 23.22
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 2 (n=417)
|
-23.7 Score on a Scale
Standard Deviation 20.75
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 4 (n=417)
|
-30.3 Score on a Scale
Standard Deviation 22.73
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 6 (n=417)
|
-34.6 Score on a Scale
Standard Deviation 22.86
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the physician global assessment of disease activity by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 2 (n=105)
|
-22.0 Score on a Scale
Standard Deviation 18.89
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 4 (n=105)
|
-27.9 Score on a Scale
Standard Deviation 19.21
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 6 (n=105)
|
-31.6 Score on a Scale
Standard Deviation 20.66
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 2 (n=3161)
|
-24.6 Score on a Scale
Standard Deviation 20.79
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 4 (n=3161)
|
-33.1 Score on a Scale
Standard Deviation 21.68
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 6 (n=3161)
|
-37.3 Score on a Scale
Standard Deviation 22.96
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: \<=1.5, \>1.5 to \<1.86, and \>=1.86.
The mean change from baseline in the physician global assessment of disease activity by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm \[best\] -100mm \[worst\]) with increasing scores indicating increased level of disease. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 2 (n=1208)
|
-26.4 Score on a Scale
Standard Deviation 21.50
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 4 (n=1208)
|
-34.7 Score on a Scale
Standard Deviation 22.21
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 6 (n=1208)
|
-39.2 Score on a Scale
Standard Deviation 23.01
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 2 (n=1005)
|
-25.2 Score on a Scale
Standard Deviation 20.46
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 4 (n=1005)
|
-34.3 Score on a Scale
Standard Deviation 21.06
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 6 (n=1005)
|
-38.0 Score on a Scale
Standard Deviation 22.25
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 2 (n=1049)
|
-21.6 Score on a Scale
Standard Deviation 19.79
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 4 (n=1049)
|
-29.6 Score on a Scale
Standard Deviation 21.11
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 6 (n=1049)
|
-33.8 Score on a Scale
Standard Deviation 23.13
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the physician global assessment of disease activity by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 4 (n=1305)
|
-33.2 Score on a Scale
Standard Deviation 21.86
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 2 (n=1305)
|
-23.7 Score on a Scale
Standard Deviation 21.25
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 6 (n=1305)
|
-37.0 Score on a Scale
Standard Deviation 23.43
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 2 (n=1101)
|
-25.6 Score on a Scale
Standard Deviation 20.53
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 4 (n=1101)
|
-33.6 Score on a Scale
Standard Deviation 21.50
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 6 (n=1101)
|
-38.8 Score on a Scale
Standard Deviation 22.62
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 2 (n=846)
|
-24.5 Score on a Scale
Standard Deviation 20.05
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 4 (n=846)
|
-31.9 Score on a Scale
Standard Deviation 21.41
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 6 (n=846)
|
-35.1 Score on a Scale
Standard Deviation 22.25
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the physician global assessment of disease activity by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 2 (n=1159)
|
-23.5 Score on a Scale
Standard Deviation 20.84
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 4 (n=1159)
|
-32.5 Score on a Scale
Standard Deviation 21.94
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 6 (n=1159)
|
-37.3 Score on a Scale
Standard Deviation 23.13
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 2 (n=1740)
|
-24.9 Score on a Scale
Standard Deviation 20.80
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 4 (n=1740)
|
-33.2 Score on a Scale
Standard Deviation 21.50
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 6 (n=1740)
|
-37.1 Score on a Scale
Standard Deviation 22.86
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 2 (n=353)
|
-26.4 Score on a Scale
Standard Deviation 19.63
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 4 (n=353)
|
-33.3 Score on a Scale
Standard Deviation 21.24
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 6 (n=353)
|
-36.6 Score on a Scale
Standard Deviation 22.29
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the physician global assessment of disease activity by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 4 (n=1060)
|
-33.7 Units on a Scale
Standard Deviation 21.96
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 6 (n=1060)
|
-37.0 Units on a Scale
Standard Deviation 23.00
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 2 (n=1095)
|
-25.0 Units on a Scale
Standard Deviation 21.38
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 4 (n=1095)
|
-32.7 Units on a Scale
Standard Deviation 22.79
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 6 (n=1095)
|
-36.0 Units on a Scale
Standard Deviation 23.67
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 2 (n=1053)
|
-23.1 Units on a Scale
Standard Deviation 19.37
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 4 (n=1053)
|
-32.4 Units on a Scale
Standard Deviation 20.04
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 6 (n=1053)
|
-38.3 Units on a Scale
Standard Deviation 21.95
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 2 (n=1060)
|
-25.5 Units on a Scale
Standard Deviation 21.04
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the physician global assessment of disease activity by the baseline physician expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm \[best\] - 100mm \[worst\]) with increasing scores indicating increased level of disease. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 2 (n=39)
|
-28.5 Units on a Scale
Standard Deviation 18.27
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 4 (n=39)
|
-37.3 Units on a Scale
Standard Deviation 24.56
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 6 (n=39)
|
-38.9 Units on a Scale
Standard Deviation 28.37
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 2 (n=325)
|
-24.1 Units on a Scale
Standard Deviation 20.53
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 4 (n=325)
|
-32.6 Units on a Scale
Standard Deviation 22.50
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 6 (n=325)
|
-37.4 Units on a Scale
Standard Deviation 23.94
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 2 (n=1927)
|
-24.8 Units on a Scale
Standard Deviation 20.72
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 4 (n=1927)
|
-33.6 Units on a Scale
Standard Deviation 21.18
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 6 (n=1927)
|
-38.0 Units on a Scale
Standard Deviation 22.40
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 2 (n=966)
|
-24.0 Units on a Scale
Standard Deviation 20.84
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 4 (n=966)
|
-31.6 Units on a Scale
Standard Deviation 21.96
|
—
|
|
Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 6 (n=966)
|
-35.1 Units on a Scale
Standard Deviation 23.21
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the DAS28-ESR was calculated by concomitant MTX dose (low \< 10mg/wk, medium \>= 10 to \< 15 mg/week, and high \>=15 mg/week) at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR \> 5.1 = high disease activity, DAS28-ESR \< 3.2 = low disease activity, and DAS28-ESR \<2.6 = remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 6 (n=142)
|
-2.23 Score on a Scale
Standard Deviation 1.358
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 2 (n=526)
|
-1.43 Score on a Scale
Standard Deviation 1.037
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 4 (n=526)
|
-2.01 Score on a Scale
Standard Deviation 1.252
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 6 (n=526)
|
-2.35 Score on a Scale
Standard Deviation 1.400
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 2 (n=1995)
|
-1.42 Score on a Scale
Standard Deviation 1.131
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 2 (n=142)
|
-1.40 Score on a Scale
Standard Deviation 1.060
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 4 (n=142)
|
-1.97 Score on a Scale
Standard Deviation 1.271
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 4 (n=1995)
|
-2.00 Score on a Scale
Standard Deviation 1.275
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 6 (n=1995)
|
-2.29 Score on a Scale
Standard Deviation 1.376
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The DAS28-ESR measures disease burden using patient global health (self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR \> 5.1 = high disease activity, DAS28-ESR \< 3.2 = low disease activity, and DAS28-ESR \<2.6 = remission. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX+sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 2 (n=1681)
|
-1.44 Score on a Scale
Standard Deviation 1.092
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 4 (n=1681)
|
-2.03 Score on a Scale
Standard Deviation 1.279
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 6 (n=1681)
|
-2.32 Score on a Scale
Standard Deviation 1.386
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 2 (n=433)
|
-1.35 Score on a Scale
Standard Deviation 1.163
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 4 (n=433)
|
-1.94 Score on a Scale
Standard Deviation 1.274
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 6 (n=433)
|
-2.32 Score on a Scale
Standard Deviation 1.329
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 2 (n=216)
|
-1.42 Score on a Scale
Standard Deviation 1.208
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 4 (n=216)
|
-1.85 Score on a Scale
Standard Deviation 1.280
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 6 (n=216)
|
-2.10 Score on a Scale
Standard Deviation 1.441
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 - Month 2 (n=150)
|
-1.39 Score on a Scale
Standard Deviation 1.059
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 -Month 4 (n=150)
|
-2.12 Score on a Scale
Standard Deviation 1.334
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 - Month 6 (n=150)
|
-2.46 Score on a Scale
Standard Deviation 1.493
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 2 (n=106)
|
-1.46 Score on a Scale
Standard Deviation 1.099
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 4 (n=106)
|
-2.09 Score on a Scale
Standard Deviation 1.148
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 6 (n=106)
|
-2.18 Score on a Scale
Standard Deviation 1.329
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 2 (n=303)
|
-1.40 Score on a Scale
Standard Deviation 1.098
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 4 (n=303)
|
-1.90 Score on a Scale
Standard Deviation 1.288
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 6 (n=303)
|
-2.13 Score on a Scale
Standard Deviation 1.352
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the DAS28-ESR by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR \> 5.1 = high disease activity, DAS28-ESR \<3.2 = low disease activity, and DAS28-ESR \<2.6 = remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 2 (n=1202)
|
-1.41 Score on a Scale
Standard Deviation 1.079
|
—
|
|
Mean Change From Baseline in DAS28-ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 4 (n=1202)
|
-2.00 Score on a Scale
Standard Deviation 1.233
|
—
|
|
Mean Change From Baseline in DAS28-ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 6 (n=1202)
|
-2.30 Score on a Scale
Standard Deviation 1.380
|
—
|
|
Mean Change From Baseline in DAS28-ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 2 (n=2078)
|
-1.41 Score on a Scale
Standard Deviation 1.123
|
—
|
|
Mean Change From Baseline in DAS28-ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 4 (n=2078)
|
-1.95 Score on a Scale
Standard Deviation 1.291
|
—
|
|
Mean Change From Baseline in DAS28-ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 6 (n=2078)
|
-2.24 Score on a Scale
Standard Deviation 1.376
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the DAS28-ESR score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed on a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR \> 5.1 = high disease activity, DAS28-ESR \< 3.2 = low disease activity, and DAS28-ESR \<2.6 = remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-ESR Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 2 (n=1129)
|
-1.47 Score on a Scale
Standard Deviation 1.142
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 4 (n=1129)
|
-2.05 Score on a Scale
Standard Deviation 1.361
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 6 (n=1129)
|
-2.32 Score on a Scale
Standard Deviation 1.471
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 2 (n=1176)
|
-1.41 Score on a Scale
Standard Deviation 1.117
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 4 (n=1176)
|
-1.93 Score on a Scale
Standard Deviation 1.254
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 6 (n=1176)
|
-2.26 Score on a Scale
Standard Deviation 1.347
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 2 (n=974)
|
-1.35 Score on a Scale
Standard Deviation 1.050
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 4 (n=974)
|
-1.92 Score on a Scale
Standard Deviation 1.175
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 6 (n=974)
|
-2.20 Score on a Scale
Standard Deviation 1.301
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the DAS28-ESR score by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed on a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR \>5.1 = high disease activity, DAS28-ESR \<3.2 = low disease activity, and DAS28-ESR \<2.6 = remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-ESR Score by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 2 (n=899)
|
-1.39 Score on a Scale
Standard Deviation 1.172
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 4 (n=899)
|
-1.97 Score on a Scale
Standard Deviation 1.380
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 6 (n=899)
|
-2.25 Score on a Scale
Standard Deviation 1.453
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 2 (n=764)
|
-1.43 Score on a Scale
Standard Deviation 1.100
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 4 (n=764)
|
-1.97 Score on a Scale
Standard Deviation 1.214
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 6 (n=764)
|
-2.23 Score on a Scale
Standard Deviation 1.361
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 2 (n=692)
|
-1.40 Score on a Scale
Standard Deviation 1.069
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 4 (n=692)
|
-1.97 Score on a Scale
Standard Deviation 1.204
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 6 (n=692)
|
-2.25 Score on a Scale
Standard Deviation 1.385
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 2 (n=924)
|
-1.44 Score on a Scale
Standard Deviation 1.076
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 4 (n=924)
|
-1.97 Score on a Scale
Standard Deviation 1.256
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 6 (n=924)
|
-2.30 Score on a Scale
Standard Deviation 1.311
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the DAS28-ESR score by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR with increasing scores indicating increased level of disease burden. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR \> 5.1 = high disease activity, DAS28-ESR \< 3.2 to \< =5.1 = low disease activity, and DAS28-ESR \<2.6 = remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-ESR Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 2 (n=698)
|
-1.10 Score on a Scale
Standard Deviation 1.001
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 4 (n=698)
|
-1.43 Score on a Scale
Standard Deviation 1.085
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 6 (n=698)
|
-1.61 Score on a Scale
Standard Deviation 1.184
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 2 (n=2572)
|
-1.50 Score on a Scale
Standard Deviation 1.111
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 4 (n=2572)
|
-2.12 Score on a Scale
Standard Deviation 1.272
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 6 (n=2572)
|
-2.45 Score on a Scale
Standard Deviation 1.368
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the DAS28-ESR by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. Increasing scores indicate increased burden of disease. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR \> 5.1 = high disease activity, DAS28-ESR \< 3.2 = low disease activity, and DAS28-ESR \<2.6 = remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-ESR Score by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 2 (n=1026)
|
-1.34 Score on a Scale
Standard Deviation 1.140
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 4 (n=1026)
|
-1.90 Score on a Scale
Standard Deviation 1.284
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 6 (n=1026)
|
-2.19 Score on a Scale
Standard Deviation 1.427
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 2 (n=1081)
|
-1.41 Score on a Scale
Standard Deviation 1.077
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 4 (n=1081)
|
-1.95 Score on a Scale
Standard Deviation 1.249
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 6 (n=1081)
|
-2.21 Score on a Scale
Standard Deviation 1.362
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 2 (n=1127)
|
-1.49 Score on a Scale
Standard Deviation 1.106
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 4 (n=1127)
|
-2.06 Score on a Scale
Standard Deviation 1.282
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 6 (n=1127)
|
-2.38 Score on a Scale
Standard Deviation 1.347
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the DAS28-ESR score by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. Increasing scores indicate increased burden of disease. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR \> 5.1 = high disease activity, DAS28-ESR \< 3.2 = low disease activity, and DAS28-ESR \<2.6 = remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-ESR Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 2 (n=1038)
|
-1.30 Score on a Scale
Standard Deviation 1.120
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 4 (n=1038)
|
-1.85 Score on a Scale
Standard Deviation 1.277
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 6 (n=1038)
|
-2.17 Score on a Scale
Standard Deviation 1.424
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 2 (n=1112)
|
-1.46 Score on a Scale
Standard Deviation 1.071
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 4 (n=1112)
|
-2.04 Score on a Scale
Standard Deviation 1.274
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 6 (n=1112)
|
-2.27 Score on a Scale
Standard Deviation 1.371
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 2 (n=1075)
|
-1.48 Score on a Scale
Standard Deviation 1.127
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 4 (n=1075)
|
-2.01 Score on a Scale
Standard Deviation 1.261
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 6 (n=1075)
|
-2.35 Score on a Scale
Standard Deviation 1.343
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR \> 5.1 = high disease activity, DAS28-ESR \< 3.2 = low disease activity, and DAS28-ESR \<2.6 = remission. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Non-Smoker - Month 2 (n=1963)
|
-1.44 Score on a Scale
Standard Deviation 1.111
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Non-Smoker - Month 4 (n=1963)
|
-2.04 Score on a Scale
Standard Deviation 1.260
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Non-Smoker - Month 6 (n=1963)
|
-2.36 Score on a Scale
Standard Deviation 1.341
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 2 (n=324)
|
-1.44 Score on a Scale
Standard Deviation 1.096
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 4 (n=324)
|
-1.88 Score on a Scale
Standard Deviation 1.227
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 6 (n=324)
|
-2.23 Score on a Scale
Standard Deviation 1.355
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 2 (n=314)
|
-1.47 Score on a Scale
Standard Deviation 1.18
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 4 (n=314)
|
-1.99 Score on a Scale
Standard Deviation 1.312
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 6 (n=314)
|
-2.28 Score on a Scale
Standard Deviation 1.399
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes <0.5 packs/day - Month 2 (n=223)
|
-1.26 Score on a Scale
Standard Deviation 1.111
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes <0.5 packs/day - Month 4 (n=223)
|
-1.87 Score on a Scale
Standard Deviation 1.309
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes <0.5 pack/day - Month 6 (n=223)
|
-2.17 Score on a Scale
Standard Deviation 1.522
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 2 (n=397)
|
-1.30 Score on a Scale
Standard Deviation 1.032
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 4 (n=397)
|
-1.76 Score on a Scale
Standard Deviation 1.234
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 6 (n=397)
|
-1.90 Score on a Scale
Standard Deviation 1.376
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 2 (n=59)
|
-1.31 Score on a Scale
Standard Deviation 1.369
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 4 (n=59)
|
-1.57 Score on a Scale
Standard Deviation 1.465
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 6 (n=59)
|
-1.77 Score on a Scale
Standard Deviation 1.521
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 2 (n=423)
|
-1.42 Score on a Scale
Standard Deviation 1.158
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 4 (n=423)
|
-1.94 Score on a Scale
Standard Deviation 1.316
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 6 (n=423)
|
-2.24 Score on a Scale
Standard Deviation 1.463
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 2 (n=454)
|
-1.41 Score on a Scale
Standard Deviation 1.049
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 4 (n=454)
|
-1.94 Score on a Scale
Standard Deviation 1.247
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 6 (n=454)
|
-2.16 Score on a Scale
Standard Deviation 1.386
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 2 (n=418)
|
-1.29 Score on a Scale
Standard Deviation 1.071
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 4 (n=418)
|
-1.69 Score on a Scale
Standard Deviation 1.227
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 6 (n=418)
|
-1.93 Score on a Scale
Standard Deviation 1.380
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the DAS28-ESR score by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR \> 5.1 = high disease activity, DAS28-ESR \< 3.2 = low disease activity, and DAS28-ESR \<2.6 = remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-ESR Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 2 (n=106)
|
-1.29 Score on a Scale
Standard Deviation 0.881
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 4 (n=106)
|
-1.87 Score on a Scale
Standard Deviation 1.051
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 6 (n=106)
|
-1.86 Score on a Scale
Standard Deviation 1.117
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 2 (n=3174)
|
-1.42 Score on a Scale
Standard Deviation 1.114
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 4 (n=3174)
|
-1.97 Score on a Scale
Standard Deviation 1.277
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 6 (n=3174)
|
-2.27 Score on a Scale
Standard Deviation 1.383
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: \<=1.5, \>1.5 to \<1.86, and \>=1.86.
The mean change from baseline in the DAS28-ESR score by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR \> 5.1 = high disease activity, DAS28-ESR \< 3.2 = low disease activity, and DAS28-ESR \<2.6 = remission. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-ESR Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 2 (n=1212)
|
-1.56 Score on a Scale
Standard Deviation 1.132
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 4 (n=1212)
|
-2.11 Score on a Scale
Standard Deviation 1.283
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 6 (n=1212)
|
-2.43 Score on a Scale
Standard Deviation 1.377
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 2 (n=1009)
|
-1.40 Score on a Scale
Standard Deviation 1.094
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 4 (n=1009)
|
-2.01 Score on a Scale
Standard Deviation 1.288
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 6 (n=1009)
|
-2.28 Score on a Scale
Standard Deviation 1.386
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 2 (n=1054)
|
-1.25 Score on a Scale
Standard Deviation 1.063
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 4 (n=1054)
|
-1.75 Score on a Scale
Standard Deviation 1.208
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 6 (n=1054)
|
-2.04 Score on a Scale
Standard Deviation 1.344
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR \> 5.1 = high disease activity, DAS28-ESR \< 3.2 = low disease activity, and DAS28-ESR \<2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 2 (n=850)
|
-1.45 Score on a Scale
Standard Deviation 1.127
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 2 (n=1305)
|
-1.35 Score on a Scale
Standard Deviation 1.073
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 4 (n=1305)
|
-1.93 Score on a Scale
Standard Deviation 1.240
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 6 (n=1305)
|
-2.20 Score on a Scale
Standard Deviation 1.342
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 2 (n=1105)
|
-1.46 Score on a Scale
Standard Deviation 1.126
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 4 (n=1105)
|
-2.03 Score on a Scale
Standard Deviation 1.313
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 6 (n=1105)
|
-2.38 Score on a Scale
Standard Deviation 1.423
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 4 (n=850)
|
-1.95 Score on a Scale
Standard Deviation 1.261
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 6 (n=850)
|
-2.22 Score on a Scale
Standard Deviation 1.359
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR \> 5.1 = high disease activity, DAS28-ESR \< 3.2 = low disease activity, and DAS28-ESR \<2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 2 (n=1160)
|
-1.36 Score on a Scale
Standard Deviation 1.063
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 4 (n=1160)
|
-1.94 Score on a Scale
Standard Deviation 1.237
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 6 (n=1160)
|
-2.22 Score on a Scale
Standard Deviation 1.359
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 2 (n=1745)
|
-1.44 Score on a Scale
Standard Deviation 1.124
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 4 (n=1745)
|
-1.97 Score on a Scale
Standard Deviation 1.293
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 6 (n=1745)
|
-2.28 Score on a Scale
Standard Deviation 1.385
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 2 (n=355)
|
-1.46 Score on a Scale
Standard Deviation 1.151
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 4 (n=355)
|
-2.05 Score on a Scale
Standard Deviation 1.269
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 6 (n=355)
|
-2.33 Score on a Scale
Standard Deviation 1.389
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR \> 5.1 = high disease activity, DAS28-ESR \< 3.2 = low disease activity, and DAS28-ESR \<2.6 = remission. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-ESR Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 2 (n=1056)
|
-1.34 Score on a Scale
Standard Deviation 1.034
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 4 (n=1056)
|
-1.89 Score on a Scale
Standard Deviation 1.154
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 6 (n=1056)
|
-2.26 Score on a Scale
Standard Deviation 1.269
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 2 (n=1061)
|
-1.46 Score on a Scale
Standard Deviation 1.095
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 4 (n=1061)
|
-2.01 Score on a Scale
Standard Deviation 1.291
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 6 (n=1061)
|
-2.26 Score on a Scale
Standard Deviation 1.392
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 2 (n=1097)
|
-1.44 Score on a Scale
Standard Deviation 1.177
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 4 (n=1097)
|
-2.00 Score on a Scale
Standard Deviation 1.350
|
—
|
|
Mean Change From Baseline in DAS28-ESR Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 6 (n=1097)
|
-2.27 Score on a Scale
Standard Deviation 1.449
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR \> 5.1 = high disease activity, DAS28-ESR \< 3.2 = low disease activity, and DAS28-ESR \<2.6 = remission. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 2 (n=40)
|
-1.84 Score on a Scale
Standard Deviation 1.388
|
—
|
|
Mean Change From Baseline in DAS28-ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 4 (n=40)
|
-2.28 Score on a Scale
Standard Deviation 1.359
|
—
|
|
Mean Change From Baseline in DAS28-ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 6 (n=40)
|
-2.54 Score on a Scale
Standard Deviation 1.638
|
—
|
|
Mean Change From Baseline in DAS28-ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 2 (n=325)
|
-1.24 Score on a Scale
Standard Deviation 1.067
|
—
|
|
Mean Change From Baseline in DAS28-ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 4 (n=325)
|
-1.72 Score on a Scale
Standard Deviation 1.160
|
—
|
|
Mean Change From Baseline in DAS28-ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 6 (n=325)
|
-2.06 Score on a Scale
Standard Deviation 1.339
|
—
|
|
Mean Change From Baseline in DAS28-ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 2 (n=1932)
|
-1.37 Score on a Scale
Standard Deviation 1.070
|
—
|
|
Mean Change From Baseline in DAS28-ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 4 (n=1932)
|
-1.95 Score on a Scale
Standard Deviation 1.252
|
—
|
|
Mean Change From Baseline in DAS28-ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 6 (n=1932)
|
-2.24 Score on a Scale
Standard Deviation 1.361
|
—
|
|
Mean Change From Baseline in DAS28-ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 2 (n=966)
|
-1.54 Score on a Scale
Standard Deviation 1.161
|
—
|
|
Mean Change From Baseline in DAS28-ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 4 (n=966)
|
-2.09 Score on a Scale
Standard Deviation 1.322
|
—
|
|
Mean Change From Baseline in DAS28-ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 6 (n=966)
|
-2.37 Score on a Scale
Standard Deviation 1.400
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the DAS28-CRP was calculated by concomitant MTX dose (low \< 10mg/wk, medium \>= 10 to \< 15 mg/week, and high \>=15 mg/week) at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP\> 5.1 = high disease activity, DAS28-CRP \< 3.2 = low disease activity, and DAS28-CRP \<2.6 = remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 2 (n=138)
|
-1.34 Score on a Scale
Standard Deviation 1.014
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 4 (n=138)
|
-1.87 Score on a Scale
Standard Deviation 1.184
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 6 (n=138)
|
-2.18 Score on a Scale
Standard Deviation 1.266
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 2 (n=519)
|
-1.38 Score on a Scale
Standard Deviation 1.011
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 4 (n=519)
|
-1.94 Score on a Scale
Standard Deviation 1.178
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 6 (n=519)
|
-2.23 Score on a Scale
Standard Deviation 1.339
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 2 (n=1967)
|
-1.34 Score on a Scale
Standard Deviation 1.067
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 4 (n=1967)
|
-1.87 Score on a Scale
Standard Deviation 1.215
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 6 (n=1967)
|
-2.16 Score on a Scale
Standard Deviation 1.286
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts \& swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP \>5.1 =high disease activity, DAS28-CRP \<3.2=low disease activity, and DAS28-CRP \<2.6=remission. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 =leflunomide.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 2 (n=1662)
|
-1.36 Score on a Scale
Standard Deviation 1.032
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 4 (n=1662)
|
-1.90 Score on a Scale
Standard Deviation 1.216
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 6 (n=1662)
|
-2.18 Score on a Scale
Standard Deviation 1.305
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 2 (n=424)
|
-1.32 Score on a Scale
Standard Deviation 1.123
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 4 (n=424)
|
-1.86 Score on a Scale
Standard Deviation 1.252
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 6 (n=424)
|
-2.21 Score on a Scale
Standard Deviation 1.254
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 2 (n=211)
|
-1.31 Score on a Scale
Standard Deviation 1.168
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 4 (n=211)
|
-1.76 Score on a Scale
Standard Deviation 1.203
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 6 (n=211)
|
-1.94 Score on a Scale
Standard Deviation 1.308
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 - Month 2 (n=147)
|
-1.33 Score on a Scale
Standard Deviation 1.022
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 -Month 4 (n=147)
|
-1.92 Score on a Scale
Standard Deviation 1.153
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 - Month 6 (n=147)
|
-2.33 Score on a Scale
Standard Deviation 1.361
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 2 (n=104)
|
-1.39 Score on a Scale
Standard Deviation 1.019
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 4 (n=104)
|
-1.95 Score on a Scale
Standard Deviation 1.127
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 6 (n=104)
|
-2.10 Score on a Scale
Standard Deviation 1.303
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 2 (n=301)
|
-1.35 Score on a Scale
Standard Deviation 1.029
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 4 (n=301)
|
-1.86 Score on a Scale
Standard Deviation 1.216
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 6 (n=301)
|
-2.06 Score on a Scale
Standard Deviation 1.279
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the DAS28-CRP by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP\> 5.1 = high disease activity, DAS28-CRP \< 3.2 = low disease activity, and DAS28-CRP \<2.6 = remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 2 (n=1187)
|
-1.34 Score on a Scale
Standard Deviation 1.013
|
—
|
|
Mean Change From Baseline in DAS28-CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 4 (n=1187)
|
-1.86 Score on a Scale
Standard Deviation 1.152
|
—
|
|
Mean Change From Baseline in DAS28-CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 6 (n=1187)
|
-2.16 Score on a Scale
Standard Deviation 1.289
|
—
|
|
Mean Change From Baseline in DAS28-CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 2 (n=2048)
|
-1.35 Score on a Scale
Standard Deviation 1.072
|
—
|
|
Mean Change From Baseline in DAS28-CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 4 (n=2048)
|
-1.86 Score on a Scale
Standard Deviation 1.237
|
—
|
|
Mean Change From Baseline in DAS28-CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 6 (n=2048)
|
-2.14 Score on a Scale
Standard Deviation 1.297
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the DAS28-CRP score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP\> 5.1 = high disease activity, DAS28-CRP \< 3.2 = low disease activity, and DAS28-CRP \<2.6 = remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-CRP Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 2 (n=1118)
|
-1.39 Score on a Scale
Standard Deviation 1.082
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 4 (n=1118)
|
-1.91 Score on a Scale
Standard Deviation 1.288
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 6 (n=1118)
|
-2.19 Score on a Scale
Standard Deviation 1.366
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 2 (n=1158)
|
-1.35 Score on a Scale
Standard Deviation 1.064
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 4 (n=1158)
|
-1.83 Score on a Scale
Standard Deviation 1.186
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 6 (n=1158)
|
-2.13 Score on a Scale
Standard Deviation 1.271
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 2 (n=958)
|
-1.30 Score on a Scale
Standard Deviation 0.993
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 4 (n=958)
|
-1.84 Score on a Scale
Standard Deviation 1.128
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 6 (n=958)
|
-2.12 Score on a Scale
Standard Deviation 1.234
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the DAS28-CRP score by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP\> 5.1 = high disease activity, DAS28-CRP \< 3.2 = low disease activity, and DAS28-CRP \<2.6 = remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-CRP Score by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 2 (n=885)
|
-1.31 Score on a Scale
Standard Deviation 1.113
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 4 (n=885)
|
-1.82 Score on a Scale
Standard Deviation 1.296
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 6 (n=885)
|
-2.10 Score on a Scale
Standard Deviation 1.353
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 2 (n=756)
|
-1.38 Score on a Scale
Standard Deviation 1.042
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 4 (n=756)
|
-1.90 Score on a Scale
Standard Deviation 1.169
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 6 (n=756)
|
-2.16 Score on a Scale
Standard Deviation 1.278
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 2 (n=681)
|
-1.33 Score on a Scale
Standard Deviation 1.022
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 4 (n=681)
|
-1.87 Score on a Scale
Standard Deviation 1.148
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 6 (n=681)
|
-2.12 Score on a Scale
Standard Deviation 1.298
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 2 (n=912)
|
-1.37 Score on a Scale
Standard Deviation 1.016
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 4 (n=912)
|
-1.87 Score on a Scale
Standard Deviation 1.188
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 6 (n=912)
|
-2.20 Score on a Scale
Standard Deviation 1.243
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the DAS28-CRP score by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP with increasing scores indicating increased burden of disease. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-CRP \> 5.1 = high disease activity, DAS28-CRP \< 3.2 to \< =5.1 = low disease activity, and DAS28-CRP \<2.6 = remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-CRP Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 2 (n=687)
|
-1.06 Score on a Scale
Standard Deviation 0.931
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 4 (n=687)
|
-1.37 Score on a Scale
Standard Deviation 1.025
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 6 (n=687)
|
-1.55 Score on a Scale
Standard Deviation 1.088
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 2 (n=2538)
|
-1.43 Score on a Scale
Standard Deviation 1.063
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 4 (n=2538)
|
-2.00 Score on a Scale
Standard Deviation 1.216
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 6 (n=2538)
|
-2.31 Score on a Scale
Standard Deviation 1.296
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the DAS28-CRP by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP\> 5.1 = high disease activity, DAS28-CRP \< 3.2 = low disease activity, and DAS28-CRP \<2.6 = remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-CRP Score by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 2 (n=1025)
|
-1.23 Score on a Scale
Standard Deviation 1.057
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 4 (n=1025)
|
-1.75 Score on a Scale
Standard Deviation 1.200
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 6 (n=1025)
|
-2.02 Score on a Scale
Standard Deviation 1.294
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 2 (n=1079)
|
-1.34 Score on a Scale
Standard Deviation 1.017
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 4 (n=1079)
|
-1.85 Score on a Scale
Standard Deviation 1.170
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 6 (n=1079)
|
-2.12 Score on a Scale
Standard Deviation 1.280
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 2 (n=1125)
|
-1.45 Score on a Scale
Standard Deviation 1.067
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 4 (n=1125)
|
-1.98 Score on a Scale
Standard Deviation 1.238
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 6 (n=1125)
|
-2.29 Score on a Scale
Standard Deviation 1.295
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the DAS28-CRP score by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP\> 5.1 = high disease activity, DAS28-CRP \< 3.2 = low disease activity, and DAS28-CRP \<2.6 = remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-CRP Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 2 (n=1027)
|
-1.22 Score on a Scale
Standard Deviation 1.048
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 4 (n=1027)
|
-1.73 Score on a Scale
Standard Deviation 1.200
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 6 (n=1027)
|
-2.02 Score on a Scale
Standard Deviation 1.285
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 2 (n=1101)
|
-1.38 Score on a Scale
Standard Deviation 1.022
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 4 (n=1101)
|
-1.92 Score on a Scale
Standard Deviation 1.208
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 6 (n=1101)
|
-2.16 Score on a Scale
Standard Deviation 1.301
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 2 (n=1070)
|
-1.43 Score on a Scale
Standard Deviation 1.072
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 4 (n=1070)
|
-1.92 Score on a Scale
Standard Deviation 1.204
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 6 (n=1070)
|
-2.26 Score on a Scale
Standard Deviation 1.284
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP\> 5.1 = high disease activity, DAS28-CRP \< 3.2 = low disease activity, and DAS28-CRP \<2.6 = remission. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Non-Smoker - Month 2 (n=1941)
|
-1.38 Score on a Scale
Standard Deviation 1.054
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Non-Smoker - Month 4 (n=1941)
|
-1.94 Score on a Scale
Standard Deviation 1.195
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Non-Smoker - Month 6 (n=1941)
|
-2.26 Score on a Scale
Standard Deviation 1.257
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 2 (n=318)
|
-1.36 Score on a Scale
Standard Deviation 1.036
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 4 (n=318)
|
-1.74 Score on a Scale
Standard Deviation 1.190
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 6 (n=318)
|
-2.11 Score on a Scale
Standard Deviation 1.309
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 2 (n=312)
|
-1.41 Score on a Scale
Standard Deviation 1.068
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 4 (n=312)
|
-1.88 Score on a Scale
Standard Deviation 1.266
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 6 (n=312)
|
-2.15 Score on a Scale
Standard Deviation 1.325
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes <0.5 packs/day - Month 2 (n=218)
|
-1.15 Score on a Scale
Standard Deviation 1.037
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes <0.5 packs/day - Month 4 (n=218)
|
-1.76 Score on a Scale
Standard Deviation 1.241
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes <0.5 pack/day - Month 6 (n=218)
|
-2.04 Score on a Scale
Standard Deviation 1.364
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 2 (n=388)
|
-1.22 Score on a Scale
Standard Deviation 0.984
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 4 (n=388)
|
-1.63 Score on a Scale
Standard Deviation 1.155
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 6 (n=388)
|
-1.77 Score on a Scale
Standard Deviation 1.289
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 2 (n=58)
|
-1.33 Score on a Scale
Standard Deviation 1.246
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 4 (n=58)
|
-1.55 Score on a Scale
Standard Deviation 1.248
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 6 (n=58)
|
-1.63 Score on a Scale
Standard Deviation 1.386
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 2 (n=418)
|
-1.34 Score on a Scale
Standard Deviation 1.088
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 4 (n=418)
|
-1.82 Score on a Scale
Standard Deviation 1.239
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 6 (n=418)
|
-2.12 Score on a Scale
Standard Deviation 1.346
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 2 (n=450)
|
-1.32 Score on a Scale
Standard Deviation 1.021
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 4 (n=450)
|
-1.83 Score on a Scale
Standard Deviation 1.195
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 6 (n=450)
|
-2.03 Score on a Scale
Standard Deviation 1.319
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 2 (n=405)
|
-1.22 Score on a Scale
Standard Deviation 0.989
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 4 (n=405)
|
-1.57 Score on a Scale
Standard Deviation 1.148
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 6 (n=405)
|
-1.81 Score on a Scale
Standard Deviation 1.294
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the DAS28-CRP score by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP\> 5.1 = high disease activity, DAS28-CRP \< 3.2 = low disease activity, and DAS28-CRP \<2.6 = remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-CRP Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 2 (n=105)
|
-1.17 Score on a Scale
Standard Deviation 0.867
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 4 (n=105)
|
-1.75 Score on a Scale
Standard Deviation 0.982
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 6 (n=105)
|
-1.81 Score on a Scale
Standard Deviation 1.086
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 2 (n=3130)
|
-1.35 Score on a Scale
Standard Deviation 1.056
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 4 (n=3130)
|
-1.87 Score on a Scale
Standard Deviation 1.213
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 6 (n=3130)
|
-2.16 Score on a Scale
Standard Deviation 1.299
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: \<=1.5, \>1.5 to \<1.86, and \>=1.86.
The mean change from baseline in the DAS28-CRP score by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP\> 5.1 = high disease activity, DAS28-CRP \< 3.2 = low disease activity, and DAS28-CRP \<2.6 = remission. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-CRP Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 2 (n=1201)
|
-1.48 Score on a Scale
Standard Deviation 1.081
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 4 (n=1201)
|
-1.97 Score on a Scale
Standard Deviation 1.225
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 6 (n=1201)
|
-2.31 Score on a Scale
Standard Deviation 1.285
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 2 (n=995)
|
-1.35 Score on a Scale
Standard Deviation 1.031
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 4 (n=995)
|
-1.92 Score on a Scale
Standard Deviation 1.212
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 6 (n=995)
|
-2.16 Score on a Scale
Standard Deviation 1.294
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 2 (n=1034)
|
-1.19 Score on a Scale
Standard Deviation 1.006
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 4 (n=1034)
|
-1.67 Score on a Scale
Standard Deviation 1.153
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 6 (n=1034)
|
-1.94 Score on a Scale
Standard Deviation 1.278
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP\> 5.1 = high disease activity, DAS28-CRP \< 3.2 = low disease activity, and DAS28-CRP \<2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 2 (n=1284)
|
-1.30 Score on a Scale
Standard Deviation 1.026
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 4 (n=1284)
|
-1.83 Score on a Scale
Standard Deviation 1.171
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 6 (n=1284)
|
-2.12 Score on a Scale
Standard Deviation 1.274
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 2 (n=1094)
|
-1.39 Score on a Scale
Standard Deviation 1.051
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 4 (n=1094)
|
-1.93 Score on a Scale
Standard Deviation 1.242
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 6 (n=1094)
|
-2.23 Score on a Scale
Standard Deviation 1.305
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 2 (n=837)
|
-1.36 Score on a Scale
Standard Deviation 1.082
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 4 (n=837)
|
-1.83 Score on a Scale
Standard Deviation 1.208
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 6 (n=837)
|
-2.09 Score on a Scale
Standard Deviation 1.301
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP\> 5.1 = high disease activity, DAS28-CRP \< 3.2 = low disease activity, and DAS28-CRP \<2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 2 (n=1147)
|
-1.31 Score on a Scale
Standard Deviation 1.028
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 4 (n=1147)
|
-1.83 Score on a Scale
Standard Deviation 1.179
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 6 (n=1147)
|
-2.16 Score on a Scale
Standard Deviation 1.281
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 2 (n=1717)
|
-1.37 Score on a Scale
Standard Deviation 1.047
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 4 (n=1717)
|
-1.87 Score on a Scale
Standard Deviation 1.220
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 6 (n=1717)
|
-2.14 Score on a Scale
Standard Deviation 1.292
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 2 (n=351)
|
-1.40 Score on a Scale
Standard Deviation 1.126
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 4 (n=351)
|
-1.93 Score on a Scale
Standard Deviation 1.225
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 6 (n=351)
|
-2.16 Score on a Scale
Standard Deviation 1.337
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP\> 5.1 = high disease activity, DAS28-CRP \< 3.2 = low disease activity, and DAS28-CRP \<2.6 = remission. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-CRP Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 2 (n=1043)
|
-1.31 Units on a Scale
Standard Deviation 1.001
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 4 (n=1043)
|
-1.81 Units on a Scale
Standard Deviation 1.111
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 6 (n=1043)
|
-2.21 Units on a Scale
Standard Deviation 1.228
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 2 (n=1049)
|
-1.36 Units on a Scale
Standard Deviation 1.040
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 4 (n=1049)
|
-1.88 Units on a Scale
Standard Deviation 1.228
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 6 (n=1049)
|
-2.13 Units on a Scale
Standard Deviation 1.297
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 2 (n=1077)
|
-1.38 Units on a Scale
Standard Deviation 1.100
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 4 (n=1077)
|
-1.90 Units on a Scale
Standard Deviation 1.269
|
—
|
|
Mean Change From Baseline in DAS28-CRP Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 6 (n=1077)
|
-2.11 Units on a Scale
Standard Deviation 1.339
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP\> 5.1 = high disease activity, DAS28-CRP \< 3.2 = low disease activity, and DAS28-CRP \<2.6 = remission. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in DAS28-CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 2 (n=40)
|
-1.68 Score on a Scale
Standard Deviation 1.084
|
—
|
|
Mean Change From Baseline in DAS28-CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 4 (n=40)
|
-2.10 Score on a Scale
Standard Deviation 1.190
|
—
|
|
Mean Change From Baseline in DAS28-CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 6 (n=40)
|
-2.57 Score on a Scale
Standard Deviation 1.485
|
—
|
|
Mean Change From Baseline in DAS28-CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 2 (n=313)
|
-1.19 Score on a Scale
Standard Deviation 0.992
|
—
|
|
Mean Change From Baseline in DAS28-CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 4 (n=313)
|
-1.67 Score on a Scale
Standard Deviation 1.104
|
—
|
|
Mean Change From Baseline in DAS28-CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 6 (n=313)
|
-1.96 Score on a Scale
Standard Deviation 1.265
|
—
|
|
Mean Change From Baseline in DAS28-CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 2 (n=1906)
|
-1.32 Score on a Scale
Standard Deviation 1.037
|
—
|
|
Mean Change From Baseline in DAS28-CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 4 (n=1906)
|
-1.85 Score on a Scale
Standard Deviation 1.207
|
—
|
|
Mean Change From Baseline in DAS28-CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 6 (n=1906)
|
-2.14 Score on a Scale
Standard Deviation 1.300
|
—
|
|
Mean Change From Baseline in DAS28-CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 2 (n=959)
|
-1.44 Score on a Scale
Standard Deviation 1.083
|
—
|
|
Mean Change From Baseline in DAS28-CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 4 (n=959)
|
-1.94 Score on a Scale
Standard Deviation 1.224
|
—
|
|
Mean Change From Baseline in DAS28-CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 6 (n=959)
|
-2.20 Score on a Scale
Standard Deviation 1.271
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the SDAI was calculated by concomitant MTX dose (low \< 10mg/wk, medium \>= 10 to \< 15 mg/week, and high \>=15 mg/week) at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm \[best\] - 10cm \[worst\]) and level of C-reactive protein (mg/dL, normal \<1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Simplified Disease Activity Index (SDAI) Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 2 (n=138)
|
-15.55 Score on a Scale
Standard Deviation 11.605
|
—
|
|
Mean Change From Baseline in the Simplified Disease Activity Index (SDAI) Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 4 (n=138)
|
-20.69 Score on a Scale
Standard Deviation 13.346
|
—
|
|
Mean Change From Baseline in the Simplified Disease Activity Index (SDAI) Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 6 (n=138)
|
-23.81 Score on a Scale
Standard Deviation 14.063
|
—
|
|
Mean Change From Baseline in the Simplified Disease Activity Index (SDAI) Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 2 (n=516)
|
-15.74 Score on a Scale
Standard Deviation 11.579
|
—
|
|
Mean Change From Baseline in the Simplified Disease Activity Index (SDAI) Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 4 (n=516)
|
-21.38 Score on a Scale
Standard Deviation 12.872
|
—
|
|
Mean Change From Baseline in the Simplified Disease Activity Index (SDAI) Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 6 (n=516)
|
-24.01 Score on a Scale
Standard Deviation 13.992
|
—
|
|
Mean Change From Baseline in the Simplified Disease Activity Index (SDAI) Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 2 (n=1959)
|
-14.99 Score on a Scale
Standard Deviation 11.920
|
—
|
|
Mean Change From Baseline in the Simplified Disease Activity Index (SDAI) Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 4 (n=1959)
|
-20.52 Score on a Scale
Standard Deviation 13.061
|
—
|
|
Mean Change From Baseline in the Simplified Disease Activity Index (SDAI) Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 6 (n=1959)
|
-23.00 Score on a Scale
Standard Deviation 13.743
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm \[best\] - 10 cm \[worst\]) and level of C-reactive protein (mg/dL, normal \<1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in SDAI Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 2 (n=1655)
|
-15.22 Score on a Scale
Standard Deviation 11.434
|
—
|
|
Mean Change From Baseline in SDAI Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 4 (n=1655)
|
-20.59 Score on a Scale
Standard Deviation 12.977
|
—
|
|
Mean Change From Baseline in SDAI Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 6 (n=1655)
|
-23.07 Score on a Scale
Standard Deviation 13.766
|
—
|
|
Mean Change From Baseline in SDAI Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 2 (n=423)
|
-15.16 Score on a Scale
Standard Deviation 12.811
|
—
|
|
Mean Change From Baseline in SDAI Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 4 (n=423)
|
-21.02 Score on a Scale
Standard Deviation 13.780
|
—
|
|
Mean Change From Baseline in SDAI Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 6 (n=423)
|
-24.31 Score on a Scale
Standard Deviation 13.540
|
—
|
|
Mean Change From Baseline in SDAI Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 2 (n=210)
|
-14.64 Score on a Scale
Standard Deviation 13.206
|
—
|
|
Mean Change From Baseline in SDAI Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 4 (n=210)
|
-19.84 Score on a Scale
Standard Deviation 13.763
|
—
|
|
Mean Change From Baseline in SDAI Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 6 (n=210)
|
-21.41 Score on a Scale
Standard Deviation 14.685
|
—
|
|
Mean Change From Baseline in SDAI Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 - Month 2 (n=146)
|
-14.86 Score on a Scale
Standard Deviation 11.590
|
—
|
|
Mean Change From Baseline in SDAI Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 -Month 4 (n=146)
|
-21.52 Score on a Scale
Standard Deviation 12.601
|
—
|
|
Mean Change From Baseline in SDAI Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 - Month 6 (n=146)
|
-24.45 Score on a Scale
Standard Deviation 14.879
|
—
|
|
Mean Change From Baseline in SDAI Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 2 (n=103)
|
-15.63 Score on a Scale
Standard Deviation 11.838
|
—
|
|
Mean Change From Baseline in SDAI Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 4 (n=103)
|
-20.71 Score on a Scale
Standard Deviation 11.925
|
—
|
|
Mean Change From Baseline in SDAI Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 6 (n=103)
|
-21.67 Score on a Scale
Standard Deviation 13.876
|
—
|
|
Mean Change From Baseline in SDAI Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 2 (n=300)
|
-14.11 Score on a Scale
Standard Deviation 11.443
|
—
|
|
Mean Change From Baseline in SDAI Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 4 (n=300)
|
-19.70 Score on a Scale
Standard Deviation 12.639
|
—
|
|
Mean Change From Baseline in SDAI Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 6 (n=300)
|
-21.41 Score on a Scale
Standard Deviation 13.670
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the SDAI by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0 cm \[best\] - 10 cm \[worst\]) and level of C-reactive protein (mg/dL, normal \<1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in SDAI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 2 (n=1182)
|
-14.86 Score on a Scale
Standard Deviation 11.130
|
—
|
|
Mean Change From Baseline in SDAI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 4 (n=1182)
|
-20.20 Score on a Scale
Standard Deviation 12.452
|
—
|
|
Mean Change From Baseline in SDAI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 6 (n=1182)
|
-22.50 Score on a Scale
Standard Deviation 13.513
|
—
|
|
Mean Change From Baseline in SDAI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 2 (n=2039)
|
-15.12 Score on a Scale
Standard Deviation 12.102
|
—
|
|
Mean Change From Baseline in SDAI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 4 (n=2039)
|
-20.54 Score on a Scale
Standard Deviation 13.367
|
—
|
|
Mean Change From Baseline in SDAI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 6 (n=2039)
|
-23.12 Score on a Scale
Standard Deviation 13.962
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the SDAI by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm \[best\] - 10 cm \[worst\]) and level of C-reactive protein (mg/dL, normal \<1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in SDAI by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 2 (n=1113)
|
-15.69 Score on a Scale
Standard Deviation 11.955
|
—
|
|
Mean Change From Baseline in SDAI by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 4 (n=1113)
|
-20.82 Score on a Scale
Standard Deviation 13.873
|
—
|
|
Mean Change From Baseline in SDAI by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 6 (n=1113)
|
-23.31 Score on a Scale
Standard Deviation 14.472
|
—
|
|
Mean Change From Baseline in SDAI by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 2 (n=1153)
|
-14.97 Score on a Scale
Standard Deviation 11.902
|
—
|
|
Mean Change From Baseline in SDAI by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 4 (n=1153)
|
-20.26 Score on a Scale
Standard Deviation 12.712
|
—
|
|
Mean Change From Baseline in SDAI by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 6 (n=1153)
|
-22.74 Score on a Scale
Standard Deviation 13.451
|
—
|
|
Mean Change From Baseline in SDAI by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 2 (n=954)
|
-14.33 Score on a Scale
Standard Deviation 11.303
|
—
|
|
Mean Change From Baseline in SDAI by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 4 (n=954)
|
-20.12 Score on a Scale
Standard Deviation 12.421
|
—
|
|
Mean Change From Baseline in SDAI by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 6 (n=954)
|
-22.60 Score on a Scale
Standard Deviation 13.430
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the SDAI by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm \[best\] - 10 cm \[worst\]) and level of C-reactive protein (mg/dL, normal \<1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in SDAI by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 6 (n=753)
|
-23.12 Score on a Scale
Standard Deviation 13.619
|
—
|
|
Mean Change From Baseline in SDAI by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 2 (n=881)
|
-14.62 Score on a Scale
Standard Deviation 12.465
|
—
|
|
Mean Change From Baseline in SDAI by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 4 (n=881)
|
-19.74 Score on a Scale
Standard Deviation 13.904
|
—
|
|
Mean Change From Baseline in SDAI by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 6 (n=881)
|
-22.04 Score on a Scale
Standard Deviation 14.136
|
—
|
|
Mean Change From Baseline in SDAI by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 2 (n=753)
|
-15.37 Score on a Scale
Standard Deviation 11.745
|
—
|
|
Mean Change From Baseline in SDAI by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 4 (n=753)
|
-20.84 Score on a Scale
Standard Deviation 12.672
|
—
|
|
Mean Change From Baseline in SDAI by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 2 (n=677)
|
-14.75 Score on a Scale
Standard Deviation 11.368
|
—
|
|
Mean Change From Baseline in SDAI by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 4 (n=677)
|
-20.50 Score on a Scale
Standard Deviation 12.587
|
—
|
|
Mean Change From Baseline in SDAI by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 6 (n=677)
|
-22.63 Score on a Scale
Standard Deviation 13.893
|
—
|
|
Mean Change From Baseline in SDAI by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 2 (n=909)
|
-15.35 Score on a Scale
Standard Deviation 11.331
|
—
|
|
Mean Change From Baseline in SDAI by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 4 (n=909)
|
-20.65 Score on a Scale
Standard Deviation 12.804
|
—
|
|
Mean Change From Baseline in SDAI by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 6 (n=909)
|
-23.71 Score on a Scale
Standard Deviation 13.516
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the SDAI by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm \[best\] - 10 cm \[worst\]) and level of C-reactive protein (mg/dL, normal \<1 mg/dL) with increasing scores indicating increased level of disease with increasing scores indicating increased burden of disease. DAS28-ESR \> 5.1 = high disease activity, DAS28-ESR \< 3.2 to \< =5.1 = low disease activity, and DAS28-ESR \<2.6 = remission. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in SDAI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 2 (n=685)
|
-9.34 Score on a Scale
Standard Deviation 8.351
|
—
|
|
Mean Change From Baseline in SDAI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 4 (n=685)
|
-12.20 Score on a Scale
Standard Deviation 8.638
|
—
|
|
Mean Change From Baseline in SDAI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 6 (n=685)
|
-13.42 Score on a Scale
Standard Deviation 8.997
|
—
|
|
Mean Change From Baseline in SDAI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 2 (n=2526)
|
-16.61 Score on a Scale
Standard Deviation 12.035
|
—
|
|
Mean Change From Baseline in SDAI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 4 (n=2526)
|
-22.66 Score on a Scale
Standard Deviation 13.121
|
—
|
|
Mean Change From Baseline in SDAI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 6 (n=2526)
|
-25.48 Score on a Scale
Standard Deviation 13.745
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the SDAI by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm \[best\] - 10 cm \[worst\]) and level of C-reactive protein (mg/dL, normal \<1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in SDAI by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 2 (n=1022)
|
-13.31 Score on a Scale
Standard Deviation 11.369
|
—
|
|
Mean Change From Baseline in SDAI by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 4 (n=1022)
|
-18.68 Score on a Scale
Standard Deviation 12.690
|
—
|
|
Mean Change From Baseline in SDAI by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 6 (n=1022)
|
-21.03 Score on a Scale
Standard Deviation 13.335
|
—
|
|
Mean Change From Baseline in SDAI by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 2 (n=1075)
|
-14.73 Score on a Scale
Standard Deviation 11.288
|
—
|
|
Mean Change From Baseline in SDAI by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 4 (n=1075)
|
-19.89 Score on a Scale
Standard Deviation 12.479
|
—
|
|
Mean Change From Baseline in SDAI by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 6 (n=1075)
|
-22.09 Score on a Scale
Standard Deviation 13.315
|
—
|
|
Mean Change From Baseline in SDAI by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 2 (n=1118)
|
-16.88 Score on a Scale
Standard Deviation 12.288
|
—
|
|
Mean Change From Baseline in SDAI by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 4 (n=1118)
|
-22.53 Score on a Scale
Standard Deviation 13.618
|
—
|
|
Mean Change From Baseline in SDAI by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 6 (n=1118)
|
-25.38 Score on a Scale
Standard Deviation 14.328
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the SDAI by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm \[best\] - 10 cm \[worst\]) and level of C-reactive protein (mg/dL, normal \<1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in SDAI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 2 (n=1024)
|
-13.40 Score on a Scale
Standard Deviation 11.370
|
—
|
|
Mean Change From Baseline in SDAI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 4 (n=1024)
|
-18.92 Score on a Scale
Standard Deviation 12.860
|
—
|
|
Mean Change From Baseline in SDAI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 6 (n=1024)
|
-21.41 Score on a Scale
Standard Deviation 13.526
|
—
|
|
Mean Change From Baseline in SDAI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 2 (n=1094)
|
-15.39 Score on a Scale
Standard Deviation 11.601
|
—
|
|
Mean Change From Baseline in SDAI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 4 (n=1094)
|
-21.01 Score on a Scale
Standard Deviation 12.787
|
—
|
|
Mean Change From Baseline in SDAI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 6 (n=1094)
|
-22.89 Score on a Scale
Standard Deviation 13.718
|
—
|
|
Mean Change From Baseline in SDAI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 2 (n=1066)
|
-16.23 Score on a Scale
Standard Deviation 12.156
|
—
|
|
Mean Change From Baseline in SDAI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 4 (n=1066)
|
-21.23 Score on a Scale
Standard Deviation 13.436
|
—
|
|
Mean Change From Baseline in SDAI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 6 (n=1066)
|
-24.38 Score on a Scale
Standard Deviation 14.046
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm \[best\] - 10 cm \[worst\]) and level of C-reactive protein (mg/dL, normal \<1 mg/dL) with increasing scores indicating increased level of disease. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 4 (n=417)
|
-20.22 Score on a Scale
Standard Deviation 13.138
|
—
|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 6 (n=417)
|
-22.30 Score on a Scale
Standard Deviation 14.299
|
—
|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 2 (n=447)
|
-14.06 Score on a Scale
Standard Deviation 11.024
|
—
|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 4 (n=447)
|
-19.43 Score on a Scale
Standard Deviation 12.462
|
—
|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 6 (n=447)
|
-20.97 Score on a Scale
Standard Deviation 13.912
|
—
|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 2 (n=404)
|
-13.27 Score on a Scale
Standard Deviation 10.943
|
—
|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 4 (n=404)
|
-17.00 Score on a Scale
Standard Deviation 12.278
|
—
|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 6 (n=404)
|
-19.27 Score on a Scale
Standard Deviation 13.313
|
—
|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Non-Smoker - Month 2 (n=1932)
|
-15.64 Score on a Scale
Standard Deviation 11.959
|
—
|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Non-Smoker - Month 4 (n=1932)
|
-21.45 Score on a Scale
Standard Deviation 13.082
|
—
|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Non-Smoker - Month 6 (n=1932)
|
-24.25 Score on a Scale
Standard Deviation 13.565
|
—
|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 2 (n=317)
|
-15.10 Score on a Scale
Standard Deviation 11.260
|
—
|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 4 (n=317)
|
-19.34 Score on a Scale
Standard Deviation 13.177
|
—
|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 6 (n=317)
|
-22.54 Score on a Scale
Standard Deviation 14.104
|
—
|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 2 (n=311)
|
-15.16 Score on a Scale
Standard Deviation 11.477
|
—
|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 4 (n=311)
|
-19.81 Score on a Scale
Standard Deviation 12.777
|
—
|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 6 (n=311)
|
-22.09 Score on a Scale
Standard Deviation 13.648
|
—
|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes <0.5 packs/day - Month 2 (n=217)
|
-13.29 Score on a Scale
Standard Deviation 11.523
|
—
|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes <0.5 packs/day - Month 4 (n=217)
|
-19.75 Score on a Scale
Standard Deviation 12.965
|
—
|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes <0.5 pack/day - Month 6 (n=217)
|
-21.63 Score on a Scale
Standard Deviation 13.986
|
—
|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 2 (n=386)
|
-12.85 Score on a Scale
Standard Deviation 10.766
|
—
|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 4 (n=386)
|
-17.31 Score on a Scale
Standard Deviation 12.300
|
—
|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 6 (n=386)
|
-18.53 Score on a Scale
Standard Deviation 13.500
|
—
|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 2 (n=58)
|
-14.23 Score on a Scale
Standard Deviation 14.048
|
—
|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 4 (n=58)
|
-17.48 Score on a Scale
Standard Deviation 13.194
|
—
|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 6 (n=58)
|
-17.91 Score on a Scale
Standard Deviation 14.453
|
—
|
|
Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 2 (n=417)
|
-15.03 Score on a Scale
Standard Deviation 11.772
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the SDAI by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm \[best\] - 10 cm \[worst\]) and level of C-reactive protein (mg/dL, normal \<1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in SDAI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 2 (n=104)
|
-12.10 Score on a Scale
Standard Deviation 9.033
|
—
|
|
Mean Change From Baseline in SDAI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 4 (n=104)
|
-17.08 Score on a Scale
Standard Deviation 10.679
|
—
|
|
Mean Change From Baseline in SDAI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 6 (n=104)
|
-17.50 Score on a Scale
Standard Deviation 11.278
|
—
|
|
Mean Change From Baseline in SDAI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible- Month 2 (n=3117)
|
-15.12 Score on a Scale
Standard Deviation 11.823
|
—
|
|
Mean Change From Baseline in SDAI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 4 (n=3117)
|
-20.52 Score on a Scale
Standard Deviation 13.094
|
—
|
|
Mean Change From Baseline in SDAI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 6 (n=3117)
|
-23.07 Score on a Scale
Standard Deviation 13.841
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: \<=1.5, \>1.5 to \<1.86, and \>=1.86.
The mean change from baseline in the SDAI by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm \[best\] - 10 cm \[worst\]) and level of C-reactive protein (mg/dL, normal \<1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in SDAI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 2 (n=1197)
|
-16.51 Score on a Scale
Standard Deviation 12.063
|
—
|
|
Mean Change From Baseline in SDAI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 4 (n=1197)
|
-21.74 Score on a Scale
Standard Deviation 13.182
|
—
|
|
Mean Change From Baseline in SDAI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 6 (n=1197)
|
-24.42 Score on a Scale
Standard Deviation 13.894
|
—
|
|
Mean Change From Baseline in SDAI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 2 (n=991)
|
-15.24 Score on a Scale
Standard Deviation 11.600
|
—
|
|
Mean Change From Baseline in SDAI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 4 (n=991)
|
-21.04 Score on a Scale
Standard Deviation 13.244
|
—
|
|
Mean Change From Baseline in SDAI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 6 (n=991)
|
-23.20 Score on a Scale
Standard Deviation 13.816
|
—
|
|
Mean Change From Baseline in SDAI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 2 (n=1029)
|
-13.09 Score on a Scale
Standard Deviation 11.276
|
—
|
|
Mean Change From Baseline in SDAI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 4 (n=1029)
|
-18.24 Score on a Scale
Standard Deviation 12.411
|
—
|
|
Mean Change From Baseline in SDAI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 6 (n=1029)
|
-20.76 Score on a Scale
Standard Deviation 13.431
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm \[best\] - 10 cm \[worst\]) and level of C-reactive protein (mg/dL, normal \<1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in SDAI by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 2 (n=1284)
|
-14.49 Score on a Scale
Standard Deviation 11.734
|
—
|
|
Mean Change From Baseline in SDAI by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 4 (n=1284)
|
-20.20 Score on a Scale
Standard Deviation 12.818
|
—
|
|
Mean Change From Baseline in SDAI by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 6 (n=1284)
|
-22.60 Score on a Scale
Standard Deviation 13.587
|
—
|
|
Mean Change From Baseline in SDAI by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 2 (n=1090)
|
-15.62 Score on a Scale
Standard Deviation 11.857
|
—
|
|
Mean Change From Baseline in SDAI by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 4 (n=1090)
|
-20.95 Score on a Scale
Standard Deviation 13.465
|
—
|
|
Mean Change From Baseline in SDAI by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 6 (n=1090)
|
-23.71 Score on a Scale
Standard Deviation 13.926
|
—
|
|
Mean Change From Baseline in SDAI by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 2 (n=833)
|
-15.10 Score on a Scale
Standard Deviation 11.571
|
—
|
|
Mean Change From Baseline in SDAI by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 4 (n=833)
|
-20.13 Score on a Scale
Standard Deviation 12.810
|
—
|
|
Mean Change From Baseline in SDAI by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 6 (n=833)
|
-22.32 Score on a Scale
Standard Deviation 13.857
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm \[best\] - 10 cm \[worst\]) and level of C-reactive protein (mg/dL, normal \<1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in SDAI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 2 (n=1146)
|
-14.71 Score on a Scale
Standard Deviation 11.851
|
—
|
|
Mean Change From Baseline in SDAI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 4 (n=1146)
|
-20.41 Score on a Scale
Standard Deviation 13.109
|
—
|
|
Mean Change From Baseline in SDAI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 6 (n=1146)
|
-23.43 Score on a Scale
Standard Deviation 13.784
|
—
|
|
Mean Change From Baseline in SDAI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 2 (n=1712)
|
-15.25 Score on a Scale
Standard Deviation 11.694
|
—
|
|
Mean Change From Baseline in SDAI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 4 (n=1712)
|
-20.50 Score on a Scale
Standard Deviation 13.078
|
—
|
|
Mean Change From Baseline in SDAI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 6 (n=1712)
|
-22.75 Score on a Scale
Standard Deviation 13.831
|
—
|
|
Mean Change From Baseline in SDAI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 2 (n=349)
|
-14.99 Score on a Scale
Standard Deviation 11.616
|
—
|
|
Mean Change From Baseline in SDAI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 4 (n=349)
|
-20.17 Score on a Scale
Standard Deviation 12.644
|
—
|
|
Mean Change From Baseline in SDAI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 6 (n=349)
|
-21.93 Score on a Scale
Standard Deviation 13.491
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm \[best\] - 10 cm \[worst\]) and level of C-reactive protein (mg/dL, normal \<1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in SDAI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 2 (n=1040)
|
-14.80 Score on a Scale
Standard Deviation 11.566
|
—
|
|
Mean Change From Baseline in SDAI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 4 (n=1040)
|
-20.65 Score on a Scale
Standard Deviation 12.437
|
—
|
|
Mean Change From Baseline in SDAI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 6 (n=1040)
|
-24.32 Score on a Scale
Standard Deviation 13.447
|
—
|
|
Mean Change From Baseline in SDAI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 2 (n=1048)
|
-15.32 Score on a Scale
Standard Deviation 11.736
|
—
|
|
Mean Change From Baseline in SDAI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 4 (n=1048)
|
-20.51 Score on a Scale
Standard Deviation 13.421
|
—
|
|
Mean Change From Baseline in SDAI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 6 (n=1048)
|
-22.65 Score on a Scale
Standard Deviation 13.603
|
—
|
|
Mean Change From Baseline in SDAI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 2 (n=1075)
|
-15.05 Score on a Scale
Standard Deviation 11.797
|
—
|
|
Mean Change From Baseline in SDAI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 4 (n=1075)
|
-20.19 Score on a Scale
Standard Deviation 13.201
|
—
|
|
Mean Change From Baseline in SDAI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 6 (n=1075)
|
-21.88 Score on a Scale
Standard Deviation 14.015
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm \[best\] - 10 cm \[worst\]) and level of C-reactive protein (mg/dL, normal \<1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in SDAI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 2 (n=959)
|
-15.16 Score on a Scale
Standard Deviation 11.560
|
—
|
|
Mean Change From Baseline in SDAI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 2 (n=39)
|
-19.26 Score on a Scale
Standard Deviation 11.686
|
—
|
|
Mean Change From Baseline in SDAI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 4 (n=39)
|
-23.66 Score on a Scale
Standard Deviation 11.626
|
—
|
|
Mean Change From Baseline in SDAI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 6 (n=39)
|
-27.55 Score on a Scale
Standard Deviation 13.633
|
—
|
|
Mean Change From Baseline in SDAI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 2 (n=313)
|
-14.78 Score on a Scale
Standard Deviation 11.904
|
—
|
|
Mean Change From Baseline in SDAI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 4 (n=313)
|
-20.39 Score on a Scale
Standard Deviation 12.757
|
—
|
|
Mean Change From Baseline in SDAI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 6 (n=313)
|
-23.22 Score on a Scale
Standard Deviation 14.029
|
—
|
|
Mean Change From Baseline in SDAI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 2 (n=1901)
|
-14.93 Score on a Scale
Standard Deviation 11.812
|
—
|
|
Mean Change From Baseline in SDAI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 4 (n=1901)
|
-20.65 Score on a Scale
Standard Deviation 13.258
|
—
|
|
Mean Change From Baseline in SDAI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 6 (n=1901)
|
-23.33 Score on a Scale
Standard Deviation 13.892
|
—
|
|
Mean Change From Baseline in SDAI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 4 (n=959)
|
-19.91 Score on a Scale
Standard Deviation 12.675
|
—
|
|
Mean Change From Baseline in SDAI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 6 (n=959)
|
-21.79 Score on a Scale
Standard Deviation 13.418
|
—
|
SECONDARY outcome
Timeframe: Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
EULAR response was assessed at the end of Month 2, Month 4, and Month 6 by the Disease Activity Score using the 28 tender and swollen joint count calculated with erythrocyte sedimentation rate values (DAS28-ESR). A good response would was defined as a decrease \>1.2 units and a final DAS28-ESR \< 3.2 units, while a moderate response was defined as a decrease \> 1.2 units and final DAS28-ESR \>= 3.2 units, OR a decrease of 0.6 to 1.2.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Number of Participants Who Achieved DAS28-ESR EULAR Response
Study Month 2
|
2127 Participants
|
—
|
|
Number of Participants Who Achieved DAS28-ESR EULAR Response
Study Month 4
|
2522 Participants
|
—
|
|
Number of Participants Who Achieved DAS28-ESR EULAR Response
Study Month 6
|
2692 Participants
|
—
|
SECONDARY outcome
Timeframe: Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR.
DAS28-CRP EULAR response is defined as a good or moderate response that results in a DAS28-CRP \>=0.6.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Number of Participants Who Achieved DAS28-CRP EULAR Response
Study Month 2
|
2199 Participants
|
—
|
|
Number of Participants Who Achieved DAS28-CRP EULAR Response
Study Month 4
|
2530 Participants
|
—
|
|
Number of Participants Who Achieved DAS28-CRP EULAR Response
Study Month 6
|
2667 Participants
|
—
|
SECONDARY outcome
Timeframe: Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR.
The number of participants achieving low disease activity or remission was calculated by the DAS28-ESR, DAS28-CRP, and SDAI at study Month 2, Month 4, and Month 6. Low disease activity by DAS28-ESR was defined as \>= 2.6 to 3.2, and remission was defined as a DAS28-ESR \<2.6. Low disease activity by DAS28-CRP was defined as DAS28-CRP \>=2.6 to 3.2, and remission was defined as DAS28-CRP \>2.6. Low disease activity by SDAI was defined as SDAI \>5.0 to \<=20, and remission was defined as SDAI \<=5.0.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Number of Participants Achieving Low Disease Activity and Remission at Month 2, Month 4, and Month 6
Low Disease Activity by DAS28-ESR - Month 2
|
545 Participants
|
—
|
|
Number of Participants Achieving Low Disease Activity and Remission at Month 2, Month 4, and Month 6
Low Disease Activity by DAS28-ESR - Month 4
|
923 Participants
|
—
|
|
Number of Participants Achieving Low Disease Activity and Remission at Month 2, Month 4, and Month 6
Low Disease Activity by DAS28-ESR - Month 6
|
1228 Participants
|
—
|
|
Number of Participants Achieving Low Disease Activity and Remission at Month 2, Month 4, and Month 6
Low Disease Activity by DAS28-CRP - Month 2
|
805 Participants
|
—
|
|
Number of Participants Achieving Low Disease Activity and Remission at Month 2, Month 4, and Month 6
Low Disease Activity by DAS28-CRP - Month 4
|
1268 Participants
|
—
|
|
Number of Participants Achieving Low Disease Activity and Remission at Month 2, Month 4, and Month 6
Low Disease Activity by DAS28-CRP - Month 6
|
1624 Participants
|
—
|
|
Number of Participants Achieving Low Disease Activity and Remission at Month 2, Month 4, and Month 6
Low Disease Activity by SDAI - Month 2
|
671 Participants
|
—
|
|
Number of Participants Achieving Low Disease Activity and Remission at Month 2, Month 4, and Month 6
Low Disease Activity by SDAI - Month 4
|
1205 Participants
|
—
|
|
Number of Participants Achieving Low Disease Activity and Remission at Month 2, Month 4, and Month 6
Low Disease Activity by SDAI - Month 6
|
1585 Participants
|
—
|
|
Number of Participants Achieving Low Disease Activity and Remission at Month 2, Month 4, and Month 6
Remission by DAS28-ESR - Month 2
|
251 Participants
|
—
|
|
Number of Participants Achieving Low Disease Activity and Remission at Month 2, Month 4, and Month 6
Remission by DAS28-ESR - Month 4
|
527 Participants
|
—
|
|
Number of Participants Achieving Low Disease Activity and Remission at Month 2, Month 4, and Month 6
Remission by DAS28-ESR - Month 6
|
784 Participants
|
—
|
|
Number of Participants Achieving Low Disease Activity and Remission at Month 2, Month 4, and Month 6
Remission by DAS28-CRP - Month 2
|
380 Participants
|
—
|
|
Number of Participants Achieving Low Disease Activity and Remission at Month 2, Month 4, and Month 6
Remission by DAS28-CRP - Month 4
|
765 Participants
|
—
|
|
Number of Participants Achieving Low Disease Activity and Remission at Month 2, Month 4, and Month 6
Remission by DAS28-CRP - Month 6
|
1065 Participants
|
—
|
|
Number of Participants Achieving Low Disease Activity and Remission at Month 2, Month 4, and Month 6
Remission by SDAI - Month 2
|
88 Participants
|
—
|
|
Number of Participants Achieving Low Disease Activity and Remission at Month 2, Month 4, and Month 6
Remission by SDAI - Month 4
|
285 Participants
|
—
|
|
Number of Participants Achieving Low Disease Activity and Remission at Month 2, Month 4, and Month 6
Remission by SDAI - Month 6
|
464 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline the disability index of the HAQ was calculated by concomitant MTX dose (low \< 10mg/wk, medium \>= 10 to \< 15 mg/week, and high \>=15 mg/week) at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst)with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 2 (n=142)
|
-0.35 Score on a Scale
Standard Deviation 0.521
|
—
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 4 (n=142)
|
-0.50 Score on a Scale
Standard Deviation 0.547
|
—
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 6 (n=142)
|
-0.58 Score on a Scale
Standard Deviation 0.631
|
—
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 2 (n=526)
|
-0.41 Score on a Scale
Standard Deviation 0.533
|
—
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 4 (n=526)
|
-0.54 Score on a Scale
Standard Deviation 0.598
|
—
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 6 (n=526)
|
-0.61 Score on a Scale
Standard Deviation 0.651
|
—
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 2 (n=1993)
|
-0.37 Score on a Scale
Standard Deviation 0.528
|
—
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 4 (n=1993)
|
-0.50 Score on a Scale
Standard Deviation 0.613
|
—
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 6 (n=1993)
|
-0.56 Score on a Scale
Standard Deviation 0.649
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in HAQ-DI by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 2 (n=1679)
|
-0.37 Score on a Scale
Standard Deviation 0.521
|
—
|
|
Mean Change From Baseline in HAQ-DI by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 4 (n=1679)
|
-0.50 Score on a Scale
Standard Deviation 0.607
|
—
|
|
Mean Change From Baseline in HAQ-DI by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 6 (n=1679)
|
-0.56 Score on a Scale
Standard Deviation 0.651
|
—
|
|
Mean Change From Baseline in HAQ-DI by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 2 (n=433)
|
-0.40 Score on a Scale
Standard Deviation 0.574
|
—
|
|
Mean Change From Baseline in HAQ-DI by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 4 (n=433)
|
-0.55 Score on a Scale
Standard Deviation 0.633
|
—
|
|
Mean Change From Baseline in HAQ-DI by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 6 (n=433)
|
-0.62 Score on a Scale
Standard Deviation 0.671
|
—
|
|
Mean Change From Baseline in HAQ-DI by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 2 (n=216)
|
-0.34 Score on a Scale
Standard Deviation 0.531
|
—
|
|
Mean Change From Baseline in HAQ-DI by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 4 (n=216)
|
-0.43 Score on a Scale
Standard Deviation 0.624
|
—
|
|
Mean Change From Baseline in HAQ-DI by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 6 (n=216)
|
-0.53 Score on a Scale
Standard Deviation 0.588
|
—
|
|
Mean Change From Baseline in HAQ-DI by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 - Month 2 (n=150)
|
-0.36 Score on a Scale
Standard Deviation 0.490
|
—
|
|
Mean Change From Baseline in HAQ-DI by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 -Month 4 (n=150)
|
-0.45 Score on a Scale
Standard Deviation 0.523
|
—
|
|
Mean Change From Baseline in HAQ-DI by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 - Month 6 (n=150)
|
-0.55 Score on a Scale
Standard Deviation 0.627
|
—
|
|
Mean Change From Baseline in HAQ-DI by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 2 (n=106)
|
-0.38 Score on a Scale
Standard Deviation 0.501
|
—
|
|
Mean Change From Baseline in HAQ-DI by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 4 (n=106)
|
-0.67 Score on a Scale
Standard Deviation 0.599
|
—
|
|
Mean Change From Baseline in HAQ-DI by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 6 (n=106)
|
-0.63 Score on a Scale
Standard Deviation 0.709
|
—
|
|
Mean Change From Baseline in HAQ-DI by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 2 (n=303)
|
-0.33 Score on a Scale
Standard Deviation 0.490
|
—
|
|
Mean Change From Baseline in HAQ-DI by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 4 (n=303)
|
-0.43 Score on a Scale
Standard Deviation 0.540
|
—
|
|
Mean Change From Baseline in HAQ-DI by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 6 (n=303)
|
-0.47 Score on a Scale
Standard Deviation 0.579
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the HAQ-DI by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in HAQ-DI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 2 (n=1201)
|
-0.32 Score on a Scale
Standard Deviation 0.476
|
—
|
|
Mean Change From Baseline in HAQ-DI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 4 (n=1201)
|
-0.47 Score on a Scale
Standard Deviation 0.582
|
—
|
|
Mean Change From Baseline in HAQ-DI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 6 (n=1201)
|
-0.51 Score on a Scale
Standard Deviation 0.612
|
—
|
|
Mean Change From Baseline in HAQ-DI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 2 (n=2076)
|
-0.39 Score on a Scale
Standard Deviation 0.542
|
—
|
|
Mean Change From Baseline in HAQ-DI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 4 (n=2076)
|
-0.51 Score on a Scale
Standard Deviation 0.604
|
—
|
|
Mean Change From Baseline in HAQ-DI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 6 (n=2076)
|
-0.58 Score on a Scale
Standard Deviation 0.653
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the HAQ-DI by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in HAQ-DI by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 2 (n=1128)
|
-0.39 Score on a Scale
Standard Deviation 0.545
|
—
|
|
Mean Change From Baseline in HAQ-DI by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 4 (n=1128)
|
-0.54 Score on a Scale
Standard Deviation 0.630
|
—
|
|
Mean Change From Baseline in HAQ-DI by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 6 (n=1128)
|
-0.60 Score on a Scale
Standard Deviation 0.679
|
—
|
|
Mean Change From Baseline in HAQ-DI by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 2 (n=1175)
|
-0.37 Score on a Scale
Standard Deviation 0.533
|
—
|
|
Mean Change From Baseline in HAQ-DI by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 4 (n=1175)
|
-0.48 Score on a Scale
Standard Deviation 0.605
|
—
|
|
Mean Change From Baseline in HAQ-DI by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 6 (n=1175)
|
-0.55 Score on a Scale
Standard Deviation 0.644
|
—
|
|
Mean Change From Baseline in HAQ-DI by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 2 (n=973)
|
-0.33 Score on a Scale
Standard Deviation 0.470
|
—
|
|
Mean Change From Baseline in HAQ-DI by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 4 (n=973)
|
-0.46 Score on a Scale
Standard Deviation 0.541
|
—
|
|
Mean Change From Baseline in HAQ-DI by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 6 (n=973)
|
-0.51 Score on a Scale
Standard Deviation 0.580
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the HAQ-DI by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in HAQ-DI by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 2 (n=897)
|
-0.36 Score on a Scale
Standard Deviation 0.547
|
—
|
|
Mean Change From Baseline in HAQ-DI by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 4 (n=897)
|
-0.50 Score on a Scale
Standard Deviation 0.619
|
—
|
|
Mean Change From Baseline in HAQ-DI by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 6 (n=897)
|
-0.57 Score on a Scale
Standard Deviation 0.669
|
—
|
|
Mean Change From Baseline in HAQ-DI by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 2 (n=763)
|
-0.38 Score on a Scale
Standard Deviation 0.532
|
—
|
|
Mean Change From Baseline in HAQ-DI by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 4 (n=763)
|
-0.49 Score on a Scale
Standard Deviation 0.621
|
—
|
|
Mean Change From Baseline in HAQ-DI by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 6 (n=763)
|
-0.56 Score on a Scale
Standard Deviation 0.662
|
—
|
|
Mean Change From Baseline in HAQ-DI by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 2 (n=692)
|
-0.40 Score on a Scale
Standard Deviation 0.531
|
—
|
|
Mean Change From Baseline in HAQ-DI by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 4 (n=692)
|
-0.54 Score on a Scale
Standard Deviation 0.602
|
—
|
|
Mean Change From Baseline in HAQ-DI by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 6 (n=692)
|
-0.58 Score on a Scale
Standard Deviation 0.642
|
—
|
|
Mean Change From Baseline in HAQ-DI by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 2 (n=924)
|
-0.33 Score on a Scale
Standard Deviation 0.470
|
—
|
|
Mean Change From Baseline in HAQ-DI by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 4 (n=924)
|
-0.45 Score on a Scale
Standard Deviation 0.545
|
—
|
|
Mean Change From Baseline in HAQ-DI by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 6 (n=924)
|
-0.52 Score on a Scale
Standard Deviation 0.582
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the HAQ-DI by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). DAS28-ESR \> 5.1 = high disease activity, DAS28-ESR \< 3.2 to \< =5.1 = low disease activity, and DAS28-ESR \<2.6 = remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in HAQ-DI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 2 (n=697)
|
-0.25 Score on a Scale
Standard Deviation 0.430
|
—
|
|
Mean Change From Baseline in HAQ-DI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 4 (n=697)
|
-0.33 Score on a Scale
Standard Deviation 0.512
|
—
|
|
Mean Change From Baseline in HAQ-DI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 6 (n=697)
|
-0.37 Score on a Scale
Standard Deviation 0.525
|
—
|
|
Mean Change From Baseline in HAQ-DI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 2 (n=2570)
|
-0.40 Score on a Scale
Standard Deviation 0.537
|
—
|
|
Mean Change From Baseline in HAQ-DI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 4 (n=2570)
|
-0.54 Score on a Scale
Standard Deviation 0.609
|
—
|
|
Mean Change From Baseline in HAQ-DI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 6 (n=2570)
|
-0.61 Score on a Scale
Standard Deviation 0.658
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the HAQ-DI by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in HAQ-DI by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 2 (n=1025)
|
-0.28 Score on a Scale
Standard Deviation 0.486
|
—
|
|
Mean Change From Baseline in HAQ-DI by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 4 (n=1025)
|
-0.41 Score on a Scale
Standard Deviation 0.580
|
—
|
|
Mean Change From Baseline in HAQ-DI by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 6 (n=1025)
|
-0.45 Score on a Scale
Standard Deviation 0.599
|
—
|
|
Mean Change From Baseline in HAQ-DI by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 2 (n=1080)
|
-0.36 Score on a Scale
Standard Deviation 0.496
|
—
|
|
Mean Change From Baseline in HAQ-DI by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 4 (n=1080)
|
-0.48 Score on a Scale
Standard Deviation 0.563
|
—
|
|
Mean Change From Baseline in HAQ-DI by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 6 (n=1080)
|
-0.52 Score on a Scale
Standard Deviation 0.602
|
—
|
|
Mean Change From Baseline in HAQ-DI by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 2 (n=1126)
|
-0.46 Score on a Scale
Standard Deviation 0.559
|
—
|
|
Mean Change From Baseline in HAQ-DI by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 4 (n=1126)
|
-0.60 Score on a Scale
Standard Deviation 0.630
|
—
|
|
Mean Change From Baseline in HAQ-DI by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 6 (n=1126)
|
-0.70 Score on a Scale
Standard Deviation 0.686
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the HAQ-DI by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in HAQ-DI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 2 (n=1036)
|
-0.28 Score on a Scale
Standard Deviation 0.475
|
—
|
|
Mean Change From Baseline in HAQ-DI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 4 (n=1036)
|
-0.41 Score on a Scale
Standard Deviation 0.567
|
—
|
|
Mean Change From Baseline in HAQ-DI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 6 (n=1036)
|
-0.45 Score on a Scale
Standard Deviation 0.587
|
—
|
|
Mean Change From Baseline in HAQ-DI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 2 (n=1112)
|
-0.40 Score on a Scale
Standard Deviation 0.527
|
—
|
|
Mean Change From Baseline in HAQ-DI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 4 (n=1112)
|
-0.52 Score on a Scale
Standard Deviation 0.607
|
—
|
|
Mean Change From Baseline in HAQ-DI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 6 (n=1112)
|
-0.58 Score on a Scale
Standard Deviation 0.641
|
—
|
|
Mean Change From Baseline in HAQ-DI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 2 (n=1074)
|
-0.43 Score on a Scale
Standard Deviation 0.535
|
—
|
|
Mean Change From Baseline in HAQ-DI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 4 (n=1074)
|
-0.55 Score on a Scale
Standard Deviation 0.604
|
—
|
|
Mean Change From Baseline in HAQ-DI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 6 (n=1074)
|
-0.63 Score on a Scale
Standard Deviation 0.666
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Non-Smoker - Month 4 (n=1960)
|
-0.52 Score on a Scale
Standard Deviation 0.615
|
—
|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Non-Smoker - Month 6 (n=1960)
|
-0.59 Score on a Scale
Standard Deviation 0.652
|
—
|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 2 (n=324)
|
-0.35 Score on a Scale
Standard Deviation 0.462
|
—
|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 4 (n=324)
|
-0.49 Score on a Scale
Standard Deviation 0.552
|
—
|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 6 (n=324)
|
-0.52 Score on a Scale
Standard Deviation 0.600
|
—
|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 2 (n=314)
|
-0.43 Score on a Scale
Standard Deviation 0.505
|
—
|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 4 (n=314)
|
-0.51 Score on a Scale
Standard Deviation 0.572
|
—
|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 6 (n=314)
|
-0.57 Score on a Scale
Standard Deviation 0.625
|
—
|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes <0.5 packs/day - Month 2 (n=223)
|
-0.30 Score on a Scale
Standard Deviation 0.480
|
—
|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes <0.5 packs/day - Month 4 (n=223)
|
-0.44 Score on a Scale
Standard Deviation 0.562
|
—
|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 2 (n=454)
|
-0.37 Score on a Scale
Standard Deviation 0.494
|
—
|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes <0.5 pack/day - Month 6 (n=223)
|
-0.52 Score on a Scale
Standard Deviation 0.628
|
—
|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 2 (n=397)
|
-0.32 Score on a Scale
Standard Deviation 0.490
|
—
|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 4 (n=454)
|
-0.48 Score on a Scale
Standard Deviation 0.567
|
—
|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 6 (n=454)
|
-0.52 Score on a Scale
Standard Deviation 0.622
|
—
|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 2 (n=418)
|
-0.31 Score on a Scale
Standard Deviation 0.455
|
—
|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 4 (n=418)
|
-0.40 Score on a Scale
Standard Deviation 0.547
|
—
|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 6 (n=418)
|
-0.42 Score on a Scale
Standard Deviation 0.572
|
—
|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 4 (n=397)
|
-0.42 Score on a Scale
Standard Deviation 0.571
|
—
|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 6 (n=397)
|
-0.45 Score on a Scale
Standard Deviation 0.616
|
—
|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 2 (n=59)
|
-0.37 Score on a Scale
Standard Deviation 0.517
|
—
|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 4 (n=59)
|
-0.34 Score on a Scale
Standard Deviation 0.539
|
—
|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 6 (n=59)
|
-0.42 Score on a Scale
Standard Deviation 0.584
|
—
|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 2 (n=423)
|
-0.38 Score on a Scale
Standard Deviation 0.513
|
—
|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 4 (n=423)
|
-0.49 Score on a Scale
Standard Deviation 0.580
|
—
|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Non-Smoker - Month 2 (n=1960)
|
-0.38 Score on a Scale
Standard Deviation 0.540
|
—
|
|
Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 6 (n=423)
|
-0.58 Score on a Scale
Standard Deviation 0.642
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the HAQ-DI by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in HAQ-DI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 2 (n=106)
|
-0.27 Score on a Scale
Standard Deviation 0.406
|
—
|
|
Mean Change From Baseline in HAQ-DI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 4 (n=106)
|
-0.44 Score on a Scale
Standard Deviation 0.565
|
—
|
|
Mean Change From Baseline in HAQ-DI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 6 (n=106)
|
-0.47 Score on a Scale
Standard Deviation 0.576
|
—
|
|
Mean Change From Baseline in HAQ-DI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible- Month 2 (n=3171)
|
-0.37 Score on a Scale
Standard Deviation 0.523
|
—
|
|
Mean Change From Baseline in HAQ-DI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 4 (n=3171)
|
-0.50 Score on a Scale
Standard Deviation 0.597
|
—
|
|
Mean Change From Baseline in HAQ-DI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
EligAnti-TNF treatment Eligible - Month 6 (n=3171)
|
-0.56 Score on a Scale
Standard Deviation 0.641
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: \<=1.5, \>1.5 to \<1.86, and \>=1.86.
The mean change from baseline in the HAQ-DI by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in HAQ-DI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 2 (n=1211)
|
-0.46 Score on a Scale
Standard Deviation 0.557
|
—
|
|
Mean Change From Baseline in HAQ-DI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 4 (n=1211)
|
-0.59 Score on a Scale
Standard Deviation 0.634
|
—
|
|
Mean Change From Baseline in HAQ-DI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 6 (n=1211)
|
-0.65 Score on a Scale
Standard Deviation 0.691
|
—
|
|
Mean Change From Baseline in HAQ-DI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 2 (n=1009)
|
-0.34 Score on a Scale
Standard Deviation 0.488
|
—
|
|
Mean Change From Baseline in HAQ-DI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 4 (n=1009)
|
-0.48 Score on a Scale
Standard Deviation 0.580
|
—
|
|
Mean Change From Baseline in HAQ-DI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 6 (n=1009)
|
-0.55 Score on a Scale
Standard Deviation 0.610
|
—
|
|
Mean Change From Baseline in HAQ-DI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 2 (n=1053)
|
-0.29 Score on a Scale
Standard Deviation 0.490
|
—
|
|
Mean Change From Baseline in HAQ-DI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 4 (n=1053)
|
-0.39 Score on a Scale
Standard Deviation 0.549
|
—
|
|
Mean Change From Baseline in HAQ-DI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 6 (n=1053)
|
-0.44 Score on a Scale
Standard Deviation 0.583
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in HAQ-DI by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 2 (n=1304)
|
-0.37 Score on a Scale
Standard Deviation 0.515
|
—
|
|
Mean Change From Baseline in HAQ-DI by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 4 (n=1304)
|
-0.48 Score on a Scale
Standard Deviation 0.573
|
—
|
|
Mean Change From Baseline in HAQ-DI by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 6 (n=1304)
|
-0.55 Score on a Scale
Standard Deviation 0.627
|
—
|
|
Mean Change From Baseline in HAQ-DI by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 2 (n=1104)
|
-0.35 Score on a Scale
Standard Deviation 0.511
|
—
|
|
Mean Change From Baseline in HAQ-DI by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 4 (n=1104)
|
-0.48 Score on a Scale
Standard Deviation 0.611
|
—
|
|
Mean Change From Baseline in HAQ-DI by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 6 (n=1104)
|
-0.54 Score on a Scale
Standard Deviation 0.644
|
—
|
|
Mean Change From Baseline in HAQ-DI by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 2 (n=850)
|
-0.39 Score on a Scale
Standard Deviation 0.535
|
—
|
|
Mean Change From Baseline in HAQ-DI by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 4 (n=850)
|
-0.53 Score on a Scale
Standard Deviation 0.607
|
—
|
|
Mean Change From Baseline in HAQ-DI by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 6 (n=850)
|
-0.59 Score on a Scale
Standard Deviation 0.650
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in HAQ-DI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 2 (n=1160)
|
-0.39 Score on a Scale
Standard Deviation 0.533
|
—
|
|
Mean Change From Baseline in HAQ-DI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 4 (n=1160)
|
-0.51 Score on a Scale
Standard Deviation 0.596
|
—
|
|
Mean Change From Baseline in HAQ-DI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 6 (n=1160)
|
-0.60 Score on a Scale
Standard Deviation 0.631
|
—
|
|
Mean Change From Baseline in HAQ-DI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 2 (n=1744)
|
-0.35 Score on a Scale
Standard Deviation 0.511
|
—
|
|
Mean Change From Baseline in HAQ-DI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 4 (n=1744)
|
-0.49 Score on a Scale
Standard Deviation 0.593
|
—
|
|
Mean Change From Baseline in HAQ-DI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 6 (n=1744)
|
-0.53 Score on a Scale
Standard Deviation 0.650
|
—
|
|
Mean Change From Baseline in HAQ-DI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 2 (n=354)
|
-0.37 Score on a Scale
Standard Deviation 0.512
|
—
|
|
Mean Change From Baseline in HAQ-DI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 4 (n=354)
|
-0.48 Score on a Scale
Standard Deviation 0.602
|
—
|
|
Mean Change From Baseline in HAQ-DI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 6 (n=354)
|
-0.54 Score on a Scale
Standard Deviation 0.607
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a scores ranging from 0 (best) to 3 (best) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in HAQ-DI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 6 (n=1097)
|
-0.55 Units on a Scale
Standard Deviation 0.664
|
—
|
|
Mean Change From Baseline in HAQ-DI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 2 (n=1055)
|
-0.39 Units on a Scale
Standard Deviation 0.529
|
—
|
|
Mean Change From Baseline in HAQ-DI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 4 (n=1055)
|
-0.51 Units on a Scale
Standard Deviation 0.594
|
—
|
|
Mean Change From Baseline in HAQ-DI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 6 (n=1055)
|
-0.59 Units on a Scale
Standard Deviation 0.625
|
—
|
|
Mean Change From Baseline in HAQ-DI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 2 (n=1060)
|
-0.35 Units on a Scale
Standard Deviation 0.501
|
—
|
|
Mean Change From Baseline in HAQ-DI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 4 (n=1060)
|
-0.48 Units on a Scale
Standard Deviation 0.580
|
—
|
|
Mean Change From Baseline in HAQ-DI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 6 (n=1060)
|
-0.53 Units on a Scale
Standard Deviation 0.627
|
—
|
|
Mean Change From Baseline in HAQ-DI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 2 (n=1097)
|
-0.36 Units on a Scale
Standard Deviation 0.529
|
—
|
|
Mean Change From Baseline in HAQ-DI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 4 (n=1097)
|
-0.50 Units on a Scale
Standard Deviation 0.609
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in HAQ-DI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 2 (n=40)
|
-0.36 Units on a Scale
Standard Deviation 0.563
|
—
|
|
Mean Change From Baseline in HAQ-DI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 4 (n=40)
|
-0.49 Units on a Scale
Standard Deviation 0.536
|
—
|
|
Mean Change From Baseline in HAQ-DI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 6 (n=40)
|
-0.54 Units on a Scale
Standard Deviation 0.593
|
—
|
|
Mean Change From Baseline in HAQ-DI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 2 (n=325)
|
-0.29 Units on a Scale
Standard Deviation 0.482
|
—
|
|
Mean Change From Baseline in HAQ-DI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 4 (n=325)
|
-0.43 Units on a Scale
Standard Deviation 0.529
|
—
|
|
Mean Change From Baseline in HAQ-DI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 6 (n=325)
|
-0.49 Units on a Scale
Standard Deviation 0.575
|
—
|
|
Mean Change From Baseline in HAQ-DI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 2 (n=1930)
|
-0.38 Units on a Scale
Standard Deviation 0.526
|
—
|
|
Mean Change From Baseline in HAQ-DI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 4 (n=1930)
|
-0.51 Units on a Scale
Standard Deviation 0.610
|
—
|
|
Mean Change From Baseline in HAQ-DI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 6 (n=1930)
|
-0.57 Units on a Scale
Standard Deviation 0.642
|
—
|
|
Mean Change From Baseline in HAQ-DI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 2 (n=966)
|
-0.38 Units on a Scale
Standard Deviation 0.515
|
—
|
|
Mean Change From Baseline in HAQ-DI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 4 (n=966)
|
-0.49 Units on a Scale
Standard Deviation 0.587
|
—
|
|
Mean Change From Baseline in HAQ-DI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 6 (n=966)
|
-0.54 Units on a Scale
Standard Deviation 0.653
|
—
|
SECONDARY outcome
Timeframe: Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR.
The number of participants that achieved minimal or absence of functional impairment as assessed by the HAQ at study Month 2, Month 4, and Month 6 was calculated. Minimal or absence of functional impairment was defined as a HAQ score of \<=0.5. The HAQ evaluates participants on a scale of 0 to 3, with 0=with no difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Number of Participants Who Achieved Minimal or Absence of Functional Impairment
Study Month 4
|
1087 Participants
|
—
|
|
Number of Participants Who Achieved Minimal or Absence of Functional Impairment
Study Month 6
|
1226 Participants
|
—
|
|
Number of Participants Who Achieved Minimal or Absence of Functional Impairment
Study Month 2
|
865 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
Concomitant MTX dose was defined as low \< 10mg/wk, medium \>= 10 to \< 15 mg/week, and and high \>=15 mg/week. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 \[best\] to 3 \[worst\]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in the EuroQOL (EQ-5D) Quality-of-Life Questionnaire by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 2 (n=142)
|
0.20 Score on a Scale
Standard Deviation 0.331
|
—
|
|
Mean Change From Baseline in the EuroQOL (EQ-5D) Quality-of-Life Questionnaire by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 4 (n=142)
|
0.25 Score on a Scale
Standard Deviation 0.318
|
—
|
|
Mean Change From Baseline in the EuroQOL (EQ-5D) Quality-of-Life Questionnaire by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Low MTX Dose - Month 6 (n=142)
|
0.26 Score on a Scale
Standard Deviation 0.312
|
—
|
|
Mean Change From Baseline in the EuroQOL (EQ-5D) Quality-of-Life Questionnaire by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 2 (n=526)
|
0.20 Score on a Scale
Standard Deviation 0.325
|
—
|
|
Mean Change From Baseline in the EuroQOL (EQ-5D) Quality-of-Life Questionnaire by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 4 (n=526)
|
0.24 Score on a Scale
Standard Deviation 0.338
|
—
|
|
Mean Change From Baseline in the EuroQOL (EQ-5D) Quality-of-Life Questionnaire by Concomitant MTX Dose at Month 2, Month 4, and Month 6
Medium MTX Dose - Month 6 (n=526)
|
0.27 Score on a Scale
Standard Deviation 0.332
|
—
|
|
Mean Change From Baseline in the EuroQOL (EQ-5D) Quality-of-Life Questionnaire by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 2 (n=1985)
|
0.20 Score on a Scale
Standard Deviation 0.311
|
—
|
|
Mean Change From Baseline in the EuroQOL (EQ-5D) Quality-of-Life Questionnaire by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 4 (n=1985)
|
0.23 Score on a Scale
Standard Deviation 0.336
|
—
|
|
Mean Change From Baseline in the EuroQOL (EQ-5D) Quality-of-Life Questionnaire by Concomitant MTX Dose at Month 2, Month 4, and Month 6
High MTX Dose - Month 6 (n=1985)
|
0.26 Score on a Scale
Standard Deviation 0.346
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 \[best\] to 3 \[worst\]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. DMARD Combination 1=MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2=MTX + leflunomide; Combination 3=MTX +sulfasalazine; Combination 4=MTX + hydrochloroquine, chloroquine, chloroquine phosphate+sulfasalazine; Combination 5=leflunomide.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in EQ-5D by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 2 (n=1672)
|
0.21 Score on a Scale
Standard Deviation 0.313
|
—
|
|
Mean Change From Baseline in EQ-5D by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 4 (n=1672)
|
0.24 Score on a Scale
Standard Deviation 0.336
|
—
|
|
Mean Change From Baseline in EQ-5D by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 1 - Month 6 (n=1672)
|
0.26 Score on a Scale
Standard Deviation 0.341
|
—
|
|
Mean Change From Baseline in EQ-5D by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 2 (n=432)
|
0.19 Score on a Scale
Standard Deviation 0.316
|
—
|
|
Mean Change From Baseline in EQ-5D by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 4 (n=432)
|
0.23 Score on a Scale
Standard Deviation 0.337
|
—
|
|
Mean Change From Baseline in EQ-5D by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 2 - Month 6 (n=432)
|
0.27 Score on a Scale
Standard Deviation 0.346
|
—
|
|
Mean Change From Baseline in EQ-5D by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 2 (n=216)
|
0.16 Score on a Scale
Standard Deviation 0.343
|
—
|
|
Mean Change From Baseline in EQ-5D by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 4 (n=216)
|
0.18 Score on a Scale
Standard Deviation 0.355
|
—
|
|
Mean Change From Baseline in EQ-5D by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 3 - Month 6 (n=216)
|
0.21 Score on a Scale
Standard Deviation 0.325
|
—
|
|
Mean Change From Baseline in EQ-5D by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 - Month 2 (n=150)
|
0.25 Score on a Scale
Standard Deviation 0.307
|
—
|
|
Mean Change From Baseline in EQ-5D by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 -Month 4 (n=150)
|
0.24 Score on a Scale
Standard Deviation 0.316
|
—
|
|
Mean Change From Baseline in EQ-5D by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 4 - Month 6 (n=150)
|
0.26 Score on a Scale
Standard Deviation 0.349
|
—
|
|
Mean Change From Baseline in EQ-5D by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 2 (n=105)
|
0.22 Score on a Scale
Standard Deviation 0.273
|
—
|
|
Mean Change From Baseline in EQ-5D by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 4 (n=105)
|
0.28 Score on a Scale
Standard Deviation 0.302
|
—
|
|
Mean Change From Baseline in EQ-5D by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 5 - Month 6 (n=105)
|
0.29 Score on a Scale
Standard Deviation 0.374
|
—
|
|
Mean Change From Baseline in EQ-5D by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 2 (n=303)
|
0.17 Score on a Scale
Standard Deviation 0.284
|
—
|
|
Mean Change From Baseline in EQ-5D by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 4 (n=303)
|
0.21 Score on a Scale
Standard Deviation 0.306
|
—
|
|
Mean Change From Baseline in EQ-5D by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6
DMARD Combination 6 - Month 6 (n=303)
|
0.19 Score on a Scale
Standard Deviation .341
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the EQ-5D by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 \[best\] to 3 \[worst\]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in EQ-5D by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 2 (n=1199)
|
0.17 Score on a Scale
Standard Deviation 0.291
|
—
|
|
Mean Change From Baseline in EQ-5D by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 4 (n=1199)
|
0.21 Score on a Scale
Standard Deviation 0.306
|
—
|
|
Mean Change From Baseline in EQ-5D by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Did Not Receive Corticosteroids - Month 6 (n=1199)
|
0.22 Score on a Scale
Standard Deviation 0.329
|
—
|
|
Mean Change From Baseline in EQ-5D by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 2 (n=2069)
|
0.21 Score on a Scale
Standard Deviation 0.322
|
—
|
|
Mean Change From Baseline in EQ-5D by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 4 (n=2069)
|
0.24 Score on a Scale
Standard Deviation 0.343
|
—
|
|
Mean Change From Baseline in EQ-5D by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6
Received Corticosteroids - Month 6 (n=2069)
|
0.27 Score on a Scale
Standard Deviation 0.348
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the EQ-5D by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 \[best\] to 3 \[worst\]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in EQ-5D by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 2 (n=1124)
|
0.21 Score on a Scale
Standard Deviation 0.324
|
—
|
|
Mean Change From Baseline in EQ-5D by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 4 (n=1124)
|
0.24 Score on a Scale
Standard Deviation 0.338
|
—
|
|
Mean Change From Baseline in EQ-5D by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 1 DMARD - Month 6 (n=1124)
|
0.27 Score on a Scale
Standard Deviation 0.347
|
—
|
|
Mean Change From Baseline in EQ-5D by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 2 (n=1173)
|
0.19 Score on a Scale
Standard Deviation 0.312
|
—
|
|
Mean Change From Baseline in EQ-5D by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 4 (n=1173)
|
0.22 Score on a Scale
Standard Deviation 0.329
|
—
|
|
Mean Change From Baseline in EQ-5D by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed 2 DMARDs - Month 6 (n=1173)
|
0.24 Score on a Scale
Standard Deviation 0.346
|
—
|
|
Mean Change From Baseline in EQ-5D by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 2 (n=970)
|
0.19 Score on a Scale
Standard Deviation 0.298
|
—
|
|
Mean Change From Baseline in EQ-5D by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 4 (n=970)
|
0.22 Score on a Scale
Standard Deviation 0.323
|
—
|
|
Mean Change From Baseline in EQ-5D by the Number of DMARD Failures at Month 2, Month 4, and Month 6
Failed >=3 DMARDs - Month 6 (n=970)
|
0.24 Score on a Scale
Standard Deviation 0.331
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the EQ-5D by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 \[best\] to 3 \[worst\]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in EQ-5D by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 4 (n=760)
|
0.23 Score on a Scale
Standard Deviation 0.319
|
—
|
|
Mean Change From Baseline in EQ-5D by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 6 (n=760)
|
0.24 Score on a Scale
Standard Deviation 0.339
|
—
|
|
Mean Change From Baseline in EQ-5D by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 2 (n=691)
|
0.22 Score on a Scale
Standard Deviation 0.315
|
—
|
|
Mean Change From Baseline in EQ-5D by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 4 (n=691)
|
0.24 Score on a Scale
Standard Deviation 0.341
|
—
|
|
Mean Change From Baseline in EQ-5D by Duration of Disease at Month 2, Month 4, and Month 6
Duration 5 to 10 years - Month 6 (n=691)
|
0.26 Score on a Scale
Standard Deviation 0.357
|
—
|
|
Mean Change From Baseline in EQ-5D by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 2 (n=923)
|
0.19 Score on a Scale
Standard Deviation 0.307
|
—
|
|
Mean Change From Baseline in EQ-5D by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 4 (n=923)
|
0.23 Score on a Scale
Standard Deviation 0.323
|
—
|
|
Mean Change From Baseline in EQ-5D by Duration of Disease at Month 2, Month 4, and Month 6
Duration > 10 years - Month 6 (n=923)
|
0.25 Score on a Scale
Standard Deviation 0.334
|
—
|
|
Mean Change From Baseline in EQ-5D by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 2 (n=893)
|
0.18 Score on a Scale
Standard Deviation 0.315
|
—
|
|
Mean Change From Baseline in EQ-5D by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 4 (n=893)
|
0.21 Score on a Scale
Standard Deviation 0.339
|
—
|
|
Mean Change From Baseline in EQ-5D by Duration of Disease at Month 2, Month 4, and Month 6
Duration < 2 years - Month 6 (n=893)
|
0.24 Score on a Scale
Standard Deviation 0.342
|
—
|
|
Mean Change From Baseline in EQ-5D by Duration of Disease at Month 2, Month 4, and Month 6
Duration 2 to <5 years - Month 2 (n=760)
|
0.21 Score on a Scale
Standard Deviation 0.311
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the EQ-5D by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 \[best\] to 3 \[worst\]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. DAS28-ESR \> 5.1 = high disease activity, DAS28-ESR \< 3.2 to \< =5.1 = low disease activity, and DAS28-ESR \<2.6 = remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in EQ-5D by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 2 (n=695)
|
0.10 Score on a Scale
Standard Deviation 0.232
|
—
|
|
Mean Change From Baseline in EQ-5D by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 4 (n=695)
|
0.12 Score on a Scale
Standard Deviation 0.253
|
—
|
|
Mean Change From Baseline in EQ-5D by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 3.2 to <=5.1 - Month 6 (n=695)
|
0.13 Score on a Scale
Standard Deviation 0.267
|
—
|
|
Mean Change From Baseline in EQ-5D by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 2 (n=2563)
|
0.22 Score on a Scale
Standard Deviation 0.325
|
—
|
|
Mean Change From Baseline in EQ-5D by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 4 (n=2563)
|
0.26 Score on a Scale
Standard Deviation 0.343
|
—
|
|
Mean Change From Baseline in EQ-5D by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6
DAS28 > 5.1 - Month 6 (n=2563)
|
0.28 Score on a Scale
Standard Deviation 0.353
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the EQ-5D by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 \[best\] to 3 \[worst\]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in EQ-5D by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 2 (n=1020)
|
0.16 Score on a Scale
Standard Deviation 0.296
|
—
|
|
Mean Change From Baseline in EQ-5D by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 4 (n=1020)
|
0.19 Score on a Scale
Standard Deviation 0.322
|
—
|
|
Mean Change From Baseline in EQ-5D by Baseline RF Level at Month 2, Month 4, and Month 6
RF <=22 IU/mL - Month 6 (n=1020)
|
0.21 Score on a Scale
Standard Deviation 0.314
|
—
|
|
Mean Change From Baseline in EQ-5D by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 2 (n=1079)
|
0.19 Score on a Scale
Standard Deviation 0.305
|
—
|
|
Mean Change From Baseline in EQ-5D by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 4 (n=1079)
|
0.22 Score on a Scale
Standard Deviation 0.324
|
—
|
|
Mean Change From Baseline in EQ-5D by Baseline RF Level at Month 2, Month 4, and Month 6
RF >22 to <=146 IU/mL - Month 6 (n=1079)
|
0.23 Score on a Scale
Standard Deviation 0.339
|
—
|
|
Mean Change From Baseline in EQ-5D by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 2 (n=1123)
|
0.25 Score on a Scale
Standard Deviation 0.328
|
—
|
|
Mean Change From Baseline in EQ-5D by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 4 (n=1123)
|
0.27 Score on a Scale
Standard Deviation 0.338
|
—
|
|
Mean Change From Baseline in EQ-5D by Baseline RF Level at Month 2, Month 4, and Month 6
RF >146 IU/mL - Month 6 (n=1123)
|
0.30 Score on a Scale
Standard Deviation 0.365
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the EQ-5D by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 \[best\] to 3 \[worst\]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in EQ-5D by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 2 (n=1033)
|
0.15 Score on a Scale
Standard Deviation 0.297
|
—
|
|
Mean Change From Baseline in EQ-5D by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 4 (n=1033)
|
0.19 Score on a Scale
Standard Deviation 0.324
|
—
|
|
Mean Change From Baseline in EQ-5D by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP <=40 U/mL - Month 6 (n=1033)
|
0.21 Score on a Scale
Standard Deviation 0.319
|
—
|
|
Mean Change From Baseline in EQ-5D by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 2 (n=1109)
|
0.21 Score on a Scale
Standard Deviation 0.313
|
—
|
|
Mean Change From Baseline in EQ-5D by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 4 (n=1109)
|
0.24 Score on a Scale
Standard Deviation 0.328
|
—
|
|
Mean Change From Baseline in EQ-5D by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >40 to <=380 U/mL - Month 6 (n=1109)
|
0.25 Score on a Scale
Standard Deviation 0.343
|
—
|
|
Mean Change From Baseline in EQ-5D by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 2 (n=1071)
|
0.23 Score on a Scale
Standard Deviation 0.321
|
—
|
|
Mean Change From Baseline in EQ-5D by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 4 (n=1071)
|
0.25 Score on a Scale
Standard Deviation 0.336
|
—
|
|
Mean Change From Baseline in EQ-5D by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6
Anti-CCP >380 U/mL - Month 6 (n=1071)
|
0.28 Score on a Scale
Standard Deviation 0.28
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 \[best\] to 3 \[worst\]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Non-Smoker - Month 2 (n=1957)
|
0.21 Score on a Scale
Standard Deviation 0.319
|
—
|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Non-Smoker - Month 4 (n=1957)
|
0.24 Score on a Scale
Standard Deviation 0.334
|
—
|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Non-Smoker - Month 6 (n=1957)
|
0.27 Score on a Scale
Standard Deviation 0.339
|
—
|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 2 (n=322)
|
0.18 Score on a Scale
Standard Deviation 0.300
|
—
|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 4 (n=322)
|
0.20 Score on a Scale
Standard Deviation 0.304
|
—
|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Smoking history >=20 years - Month 6 (n=322)
|
0.21 Score on a Scale
Standard Deviation 0.324
|
—
|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 2 (n=312)
|
0.19 Score on a Scale
Standard Deviation 0.315
|
—
|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 4 (n=312)
|
0.22 Score on a Scale
Standard Deviation 0.334
|
—
|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Smoking history <20 years - Month 6 (n=312)
|
0.24 Score on a Scale
Standard Deviation 0.351
|
—
|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes <0.5 packs/day - Month 2 (n=223)
|
0.16 Score on a Scale
Standard Deviation 0.301
|
—
|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes <0.5 packs/day - Month 4 (n=223)
|
0.20 Score on a Scale
Standard Deviation 0.338
|
—
|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes <0.5 pack/day - Month 6 (n=223)
|
0.24 Score on a Scale
Standard Deviation 0.344
|
—
|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 2 (n=395)
|
0.20 Score on a Scale
Standard Deviation 0.296
|
—
|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 4 (n=395)
|
0.20 Score on a Scale
Standard Deviation 0.327
|
—
|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes 0.5-1 pack/day - Month 6 (n=395)
|
0.21 Score on a Scale
Standard Deviation 0.363
|
—
|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 2 (n=59)
|
0.14 Score on a Scale
Standard Deviation 0.269
|
—
|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 4 (n=59)
|
0.15 Score on a Scale
Standard Deviation 0.292
|
—
|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Currently smokes >1 packs/day - Month 6 (n=59)
|
0.19 Score on a Scale
Standard Deviation 0.325
|
—
|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 2 (n=421)
|
0.21 Score on a Scale
Standard Deviation 0.314
|
—
|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 4 (n=421)
|
0.22 Score on a Scale
Standard Deviation 0.333
|
—
|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Pack years <7.5 - Month 6 (n=421)
|
0.26 Score on a Scale
Standard Deviation 0.357
|
—
|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 2 (n=453)
|
0.17 Score on a Scale
Standard Deviation 0.284
|
—
|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 4 (n=453)
|
0.20 Score on a Scale
Standard Deviation 0.310
|
—
|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Pack years 7.5 to 20.5 - Month 6 (n=453)
|
0.335 Score on a Scale
Standard Deviation 0.19
|
—
|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 2 (n=415)
|
0.17 Score on a Scale
Standard Deviation 0.301
|
—
|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 4 (n=415)
|
0.19 Score on a Scale
Standard Deviation 0.325
|
—
|
|
Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6
Pack years >20.5 - Month 6 (n=415)
|
0.19 Score on a Scale
Standard Deviation 0.342
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The mean change from baseline in the EQ-5D by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 \[best\] to 3 \[worst\]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in EQ-5D by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 4 (n=3162)
|
0.23 Score on a Scale
Standard Deviation 0.331
|
—
|
|
Mean Change From Baseline in EQ-5D by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 2 (n=106)
|
0.15 Score on a Scale
Standard Deviation 0.298
|
—
|
|
Mean Change From Baseline in EQ-5D by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 4 (n=106)
|
0.18 Score on a Scale
Standard Deviation 0.305
|
—
|
|
Mean Change From Baseline in EQ-5D by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Ineligible - Month 6 (n=106)
|
0.19 Score on a Scale
Standard Deviation 0.305
|
—
|
|
Mean Change From Baseline in EQ-5D by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 2 (n=3162)
|
0.20 Score on a Scale
Standard Deviation 0.312
|
—
|
|
Mean Change From Baseline in EQ-5D by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6
Anti-TNF treatment Eligible - Month 6 (n=3162)
|
0.25 Score on a Scale
Standard Deviation 0.343
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: \<=1.5, \>1.5 to \<1.86, and \>=1.86.
The mean change from baseline in the EQ-5D by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 \[best\] to 3 \[worst\]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in EQ-5D by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 2 (n=1208)
|
0.22 Score on a Scale
Standard Deviation 0.323
|
—
|
|
Mean Change From Baseline in EQ-5D by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 4 (n=1208)
|
0.26 Score on a Scale
Standard Deviation 0.337
|
—
|
|
Mean Change From Baseline in EQ-5D by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
<=1.5 - Month 6 (n=1208)
|
0.28 Score on a Scale
Standard Deviation 0.349
|
—
|
|
Mean Change From Baseline in EQ-5D by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 2 (n=1006)
|
0.20 Score on a Scale
Standard Deviation 0.304
|
—
|
|
Mean Change From Baseline in EQ-5D by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 4 (n=1006)
|
0.23 Score on a Scale
Standard Deviation 0.319
|
—
|
|
Mean Change From Baseline in EQ-5D by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>1.5 to 1.86 - Month 6 (n=1006)
|
0.25 Score on a Scale
Standard Deviation 0.331
|
—
|
|
Mean Change From Baseline in EQ-5D by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 2 (n=1050)
|
0.17 Score on a Scale
Standard Deviation 0.304
|
—
|
|
Mean Change From Baseline in EQ-5D by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 4 (n=1050)
|
0.19 Score on a Scale
Standard Deviation 0.329
|
—
|
|
Mean Change From Baseline in EQ-5D by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
>=1.86 - Month 6 (n=1050)
|
0.21 Score on a Scale
Standard Deviation 0.341
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 \[best\] to 3 \[worst\]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in EQ-5D by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 2 (n=1300)
|
0.20 Score on a Scale
Standard Deviation 0.311
|
—
|
|
Mean Change From Baseline in EQ-5D by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 4 (n=1300)
|
0.23 Score on a Scale
Standard Deviation 0.335
|
—
|
|
Mean Change From Baseline in EQ-5D by Physician Experience Level at Month 2, Month 4, and Month 6
<=10 years - Month 6 (n=1300)
|
0.25 Score on a Scale
Standard Deviation 0.352
|
—
|
|
Mean Change From Baseline in EQ-5D by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 2 (n=1103)
|
0.18 Score on a Scale
Standard Deviation 0.316
|
—
|
|
Mean Change From Baseline in EQ-5D by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 4 (n=1103)
|
0.22 Score on a Scale
Standard Deviation 0.331
|
—
|
|
Mean Change From Baseline in EQ-5D by Physician Experience Level at Month 2, Month 4, and Month 6
>10 to 20 years - Month 6 (n=1103)
|
0.24 Score on a Scale
Standard Deviation 0.340
|
—
|
|
Mean Change From Baseline in EQ-5D by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 2 (n=847)
|
0.21 Score on a Scale
Standard Deviation 0.309
|
—
|
|
Mean Change From Baseline in EQ-5D by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 4 (n=847)
|
0.25 Score on a Scale
Standard Deviation 0.322
|
—
|
|
Mean Change From Baseline in EQ-5D by Physician Experience Level at Month 2, Month 4, and Month 6
>20 years - Month 6 (n=847)
|
0.26 Score on a Scale
Standard Deviation 0.330
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 \[best\] to 3 \[worst\]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in EQ-5D by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 2 (n=1154)
|
0.21 Score on a Scale
Standard Deviation 0.319
|
—
|
|
Mean Change From Baseline in EQ-5D by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 4 (n=1154)
|
0.24 Score on a Scale
Standard Deviation 0.347
|
—
|
|
Mean Change From Baseline in EQ-5D by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
0 to 6 years - Month 6 (n=1154)
|
0.26 Score on a Scale
Standard Deviation 0.356
|
—
|
|
Mean Change From Baseline in EQ-5D by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 2 (n=1743)
|
0.19 Score on a Scale
Standard Deviation 0.310
|
—
|
|
Mean Change From Baseline in EQ-5D by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 4 (n=1743)
|
0.23 Score on a Scale
Standard Deviation 0.324
|
—
|
|
Mean Change From Baseline in EQ-5D by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
6 to 10 years - Month 6 (n=1743)
|
0.24 Score on a Scale
Standard Deviation 0.338
|
—
|
|
Mean Change From Baseline in EQ-5D by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 2 (n=353)
|
0.18 Score on a Scale
Standard Deviation 0.300
|
—
|
|
Mean Change From Baseline in EQ-5D by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 4 (n=353)
|
0.21 Score on a Scale
Standard Deviation 0.309
|
—
|
|
Mean Change From Baseline in EQ-5D by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6
>10 years - Month 6 (n=353)
|
0.24 Score on a Scale
Standard Deviation 0.318
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 \[best\] to 3 \[worst\]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in EQ-5D by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 6 (n=1093)
|
0.25 Units on a Scale
Standard Deviation 0.350
|
—
|
|
Mean Change From Baseline in EQ-5D by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 2 (n=1052)
|
0.21 Units on a Scale
Standard Deviation 0.307
|
—
|
|
Mean Change From Baseline in EQ-5D by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 4 (n=1052)
|
0.24 Units on a Scale
Standard Deviation 0.326
|
—
|
|
Mean Change From Baseline in EQ-5D by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
1-17 patients in prior month - Month 6 (n=1052)
|
0.26 Units on a Scale
Standard Deviation 0.339
|
—
|
|
Mean Change From Baseline in EQ-5D by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 2 (n=1059)
|
0.18 Units on a Scale
Standard Deviation 0.312
|
—
|
|
Mean Change From Baseline in EQ-5D by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 4 (n=1059)
|
0.21 Units on a Scale
Standard Deviation 0.327
|
—
|
|
Mean Change From Baseline in EQ-5D by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
18-34 patients in prior month - Month 6 (n=1059)
|
0.24 Units on a Scale
Standard Deviation 0.338
|
—
|
|
Mean Change From Baseline in EQ-5D by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 2 (n=1093)
|
0.20 Units on a Scale
Standard Deviation 0.319
|
—
|
|
Mean Change From Baseline in EQ-5D by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6
>=35 patients in prior month - Month 4 (n=1093)
|
0.24 Units on a Scale
Standard Deviation 0.340
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.
The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant indicates their health state by ticking the box against the most appropriate statement. The digits (1 \[best\] to 3 \[worst\]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Change From Baseline in EQ-5D by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 2 (n=38)
|
0.24 Units on a Scale
Standard Deviation 0.315
|
—
|
|
Mean Change From Baseline in EQ-5D by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 4 (n=38)
|
0.20 Units on a Scale
Standard Deviation 0.355
|
—
|
|
Mean Change From Baseline in EQ-5D by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
High disease activity - Month 6 (n=38)
|
0.20 Units on a Scale
Standard Deviation 0.352
|
—
|
|
Mean Change From Baseline in EQ-5D by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 2 (n=325)
|
0.18 Units on a Scale
Standard Deviation 0.298
|
—
|
|
Mean Change From Baseline in EQ-5D by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 4 (n=325)
|
0.23 Units on a Scale
Standard Deviation 0.320
|
—
|
|
Mean Change From Baseline in EQ-5D by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Moderate disease activity - Month 6 (n=325)
|
0.25 Units on a Scale
Standard Deviation 0.320
|
—
|
|
Mean Change From Baseline in EQ-5D by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 2 (n=1926)
|
0.20 Units on a Scale
Standard Deviation 0.323
|
—
|
|
Mean Change From Baseline in EQ-5D by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 4 (n=1926)
|
0.23 Units on a Scale
Standard Deviation 0.335
|
—
|
|
Mean Change From Baseline in EQ-5D by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Low disease activity - Month 6 (n=1926)
|
0.25 Units on a Scale
Standard Deviation 0.349
|
—
|
|
Mean Change From Baseline in EQ-5D by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 2 (n=964)
|
0.19 Units on a Scale
Standard Deviation 0.295
|
—
|
|
Mean Change From Baseline in EQ-5D by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 4 (n=964)
|
0.22 Units on a Scale
Standard Deviation 0.323
|
—
|
|
Mean Change From Baseline in EQ-5D by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6
Remission - Month 6 (n=964)
|
0.23 Units on a Scale
Standard Deviation 0.335
|
—
|
SECONDARY outcome
Timeframe: Month 2, Month 4, Month 6Population: The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR.
The number of participants achieving PASS was evaluated at study Month 2, Month 4, and Month 6 was calculated. PASS is participant self-evaluation tool that uses a VAS 0mm (best) - 100mm (worst), with a score \<=31 representing an acceptable PASS.
Outcome measures
| Measure |
GLM50-SC
n=3280 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Number of Participants With a Participant Acceptable Symptom State (PASS) at Month 4, Month 6, and Month 8
Study Month 2
|
1578 Participants
|
—
|
|
Number of Participants With a Participant Acceptable Symptom State (PASS) at Month 4, Month 6, and Month 8
Study Month 4
|
1889 Participants
|
—
|
|
Number of Participants With a Participant Acceptable Symptom State (PASS) at Month 4, Month 6, and Month 8
Study Month 6
|
2164 Participants
|
—
|
SECONDARY outcome
Timeframe: End of Month 6, End of Month 12Population: 8 participants (3 poor quality data, 4 without a post-baseline DAS28-ESR, and 1 did not take Part 2 medication) and 7 participants (5 poor data quality, 1 without a DAS28-ESR at baseline, 1 without post-baseline DAS28-ESR) were excluded from the efficacy evaluable population for the IV-GLM 2mg/kg + SC GLM 50 mg and SC-GLM50 arms, respectively.
The DAS28-ESR is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR, and participant assessment of disease activity measure on a visual analogue scale. The DAS28-ESR has numeric thresholds that define high disease activity (\> 5.1), low disease activity (\< 3.2) and remission (\< 2.6). Minimum score=0 (best) to maximum score=10 (worst). The DAS28-ESR area under the curve can be calculated from the DAS28-ESR score versus time curve to provide an assessment of changes in disease activity over time. The area under the DAS28-ESR score versus time curve was computed using the trapezoidal rule and using raw DAS28-ESR score values at Part-2 Baseline, end of Month 12, and at least 2 intermediate time points. The DAS28-ESR area under the curve was then averaged over the total duration (months) and expressed as units on a scale.
Outcome measures
| Measure |
GLM50-SC
n=242 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
n=248 Participants
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Mean Area Under the DAS28-ESR Curve From Study Month 6 to Month 12
|
3.67 Units on a Scale
Standard Deviation 0.992
|
3.67 Units on a Scale
Standard Deviation 0.924
|
SECONDARY outcome
Timeframe: Start of Month 8, Start of Month 9, Start of Month 10, Start of Month 11, End of Month 12Population: 8 participants (3 poor quality data, 4 without a post-baseline DAS28-ESR, and 1 did not take Part 2 medication) and 7 participants (5 poor data quality, 1 without a DAS28-ESR at baseline, 1 without post-baseline DAS28-ESR) were excluded from the efficacy evaluable population for the IV-GLM 2mg/kg + SC GLM 50 mg and SC-GLM50 arms, respectively.
Remission was defined as achievement of a DAS28-ESR \< 2.6.
Outcome measures
| Measure |
GLM50-SC
n=242 Participants
Participants received subcutaneous golimumab 50 mg once monthly.
|
SC-GLM50
n=248 Participants
Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
|
|---|---|---|
|
Percentage of Participants Achieving Remission
Start of Month 8
|
19.8 Percentage of Participants
Interval 15.3 to 25.4
|
13.7 Percentage of Participants
Interval 10.0 to 18.7
|
|
Percentage of Participants Achieving Remission
Start of Month 9
|
28.2 Percentage of Participants
Interval 23.0 to 34.4
|
20.1 Percentage of Participants
Interval 15.7 to
|
|
Percentage of Participants Achieving Remission
Start of Month 10
|
34.2 Percentage of Participants
Interval 28.6 to 40.6
|
29.5 Percentage of Participants
Interval to 35.6
|
|
Percentage of Participants Achieving Remission
Start of Month 11
|
40.3 Percentage of Participants
Interval 34.3 to 46.8
|
39.3 Percentage of Participants
Interval 33.5 to 45.7
|
|
Percentage of Participants Achieving Remission
End of Month 12
|
44.3 Percentage of Participants
Interval 38.2 to 50.9
|
45.1 Percentage of Participants
Interval 39.1 to 51.5
|
Adverse Events
Golimumab 50 mg Subcutaneous (GLM50-SC)
Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg
SC-GLM50
Serious adverse events
| Measure |
Golimumab 50 mg Subcutaneous (GLM50-SC)
n=3357 participants at risk
Participants received GLM50-SC once monthly for a period of 6 months.
|
Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg
n=245 participants at risk
Participants received IV-GLM at a dose of 2 mg/kg at the start of Month 7, start of Month 8, and start of Month 10 if remission was not achieved at any of these IV administration visits. If remission was achieved, participants were switched subcutaneous golimumab
at a dose of 50 mg once monthly.
|
SC-GLM50
n=255 participants at risk
Participants received subcutaneous golimumab at a dose of 50 mg once monthly for a period of 6 months in Part 2 of the study.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.27%
9/3357 • Number of events 10
|
0.82%
2/245 • Number of events 2
|
0.39%
1/255 • Number of events 1
|
|
Infections and infestations
Arthritis bacterial
|
0.15%
5/3357 • Number of events 5
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Sepsis
|
0.15%
5/3357 • Number of events 5
|
0.41%
1/245 • Number of events 1
|
0.00%
0/255
|
|
Infections and infestations
Tuberculosis
|
0.12%
4/3357 • Number of events 5
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Respiratory tract infection
|
0.09%
3/3357 • Number of events 3
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Urinary Tract Infection
|
0.09%
3/3357 • Number of events 3
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Cellulitis
|
0.06%
2/3357 • Number of events 2
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Gastroenteritis
|
0.06%
2/3357 • Number of events 2
|
0.41%
1/245 • Number of events 1
|
0.00%
0/255
|
|
Infections and infestations
Peritonsillar abcess
|
0.06%
2/3357 • Number of events 2
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Rotavirus infection
|
0.06%
2/3357 • Number of events 2
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Viral infection
|
0.06%
2/3357 • Number of events 2
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Abcess oral
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Beta haemolytic streptococcal infection
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Bronchitis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Erysipelas
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Groin abcess
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Helicobacter gastritis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Herpes zoster
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.39%
1/255 • Number of events 1
|
|
Infections and infestations
Herpes zoster oticus
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Infected skin ulcer
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Listeria sepsis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Lower respiratory tract infection
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Ludwig angina
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Lung infection
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Lymph node tuberculosis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Paronychia
|
0.00%
0/3357
|
0.41%
1/245 • Number of events 1
|
0.00%
0/255
|
|
Infections and infestations
Pyelonephritis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.39%
1/255 • Number of events 1
|
|
Infections and infestations
Oral candidiasis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Osteomyelitis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Otitis media acute
|
0.03%
1/3357 • Number of events 1
|
0.41%
1/245 • Number of events 1
|
0.00%
0/255
|
|
Infections and infestations
Pharyngitis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Rash pustular
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Salmonellosis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Septic shock
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Sinusitis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Syphillis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Tonsillitis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Infections and infestations
Tracheitis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/3357
|
0.41%
1/245 • Number of events 1
|
0.00%
0/255
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.27%
9/3357 • Number of events 9
|
0.41%
1/245 • Number of events 1
|
0.00%
0/255
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.12%
4/3357 • Number of events 4
|
0.00%
0/245
|
0.00%
0/255
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.09%
3/3357 • Number of events 3
|
0.00%
0/245
|
0.00%
0/255
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.09%
3/3357 • Number of events 3
|
0.00%
0/245
|
0.00%
0/255
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.09%
3/3357 • Number of events 3
|
0.00%
0/245
|
0.00%
0/255
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.06%
2/3357 • Number of events 2
|
0.00%
0/245
|
0.00%
0/255
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Musculoskeletal and connective tissue disorders
Lumbar spine stenosis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Musculoskeletal and connective tissue disorders
Meniscal degeneration
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Musculoskeletal and connective tissue disorders
Polychondritis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/3357
|
0.41%
1/245 • Number of events 1
|
0.00%
0/255
|
|
Injury, poisoning and procedural complications
Overdose
|
0.15%
5/3357 • Number of events 5
|
0.82%
2/245 • Number of events 2
|
0.39%
1/255 • Number of events 1
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.06%
2/3357 • Number of events 2
|
0.00%
0/245
|
0.00%
0/255
|
|
Injury, poisoning and procedural complications
Fall
|
0.06%
2/3357 • Number of events 3
|
0.00%
0/245
|
0.00%
0/255
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.06%
2/3357 • Number of events 2
|
0.41%
1/245 • Number of events 1
|
0.00%
0/255
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.06%
2/3357 • Number of events 2
|
0.00%
0/245
|
0.00%
0/255
|
|
Musculoskeletal and connective tissue disorders
Ankle fracture
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Injury, poisoning and procedural complications
Face injury
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.03%
1/3357 • Number of events 2
|
0.00%
0/245
|
0.00%
0/255
|
|
Injury, poisoning and procedural complications
Synovial rupture
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Injury, poisoning and procedural complications
Wound
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.12%
4/3357 • Number of events 4
|
0.00%
0/245
|
0.00%
0/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.06%
2/3357 • Number of events 2
|
0.00%
0/245
|
0.00%
0/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell carcinoma
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.03%
1/3357 • Number of events 1
|
0.41%
1/245 • Number of events 1
|
0.00%
0/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/3357
|
0.00%
0/245
|
0.39%
1/255 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.00%
0/3357
|
0.00%
0/245
|
0.39%
1/255 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/3357
|
0.00%
0/245
|
0.39%
1/255 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.09%
3/3357 • Number of events 4
|
0.41%
1/245 • Number of events 1
|
0.00%
0/255
|
|
Gastrointestinal disorders
Gastritis
|
0.06%
2/3357 • Number of events 2
|
0.00%
0/245
|
0.00%
0/255
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.06%
2/3357 • Number of events 2
|
0.00%
0/245
|
0.00%
0/255
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.06%
2/3357 • Number of events 2
|
0.00%
0/245
|
0.00%
0/255
|
|
Gastrointestinal disorders
Appendix disorder
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Gastrointestinal disorders
Diarrhoea
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Gastrointestinal disorders
Dyspepsia
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Gastrointestinal disorders
Enterocolitis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Gastrointestinal disorders
Gastritis atrophic
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Gastrointestinal disorders
Lumbar hernia
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Gastrointestinal disorders
Oesophageal varicies hemorrhage
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Gastrointestinal disorders
Oesophagitis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Gastrointestinal disorders
Small intestine obstruction
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Gastrointestinal disorders
Vomiting
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/3357
|
0.41%
1/245 • Number of events 1
|
0.00%
0/255
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.12%
4/3357 • Number of events 4
|
0.41%
1/245 • Number of events 1
|
0.00%
0/255
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.09%
3/3357 • Number of events 3
|
0.00%
0/245
|
0.00%
0/255
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.09%
3/3357 • Number of events 4
|
0.00%
0/245
|
0.00%
0/255
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Respiratory, thoracic and mediastinal disorders
Lung cyst
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/3357
|
0.41%
1/245 • Number of events 2
|
0.00%
0/255
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/3357
|
0.41%
1/245 • Number of events 1
|
0.00%
0/255
|
|
Cardiac disorders
Atrial fibriliation
|
0.09%
3/3357 • Number of events 4
|
0.41%
1/245 • Number of events 1
|
0.00%
0/255
|
|
Cardiac disorders
Acute myocardial infarction
|
0.06%
2/3357 • Number of events 2
|
0.00%
0/245
|
0.00%
0/255
|
|
Cardiac disorders
Angina pectoris
|
0.06%
2/3357 • Number of events 2
|
0.00%
0/245
|
0.00%
0/255
|
|
Cardiac disorders
Myocardial infarction
|
0.06%
2/3357 • Number of events 2
|
0.00%
0/245
|
0.00%
0/255
|
|
Cardiac disorders
Angina unstable
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Cardiac disorders
Arrhythmia
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Cardiac disorders
Cardiac failure congestive
|
0.03%
1/3357 • Number of events 1
|
0.41%
1/245 • Number of events 1
|
0.00%
0/255
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Cardiac disorders
Palpitations
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Cardiac disorders
Tachyarrhythmia
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Nervous system disorders
Cerebral infarction
|
0.09%
3/3357 • Number of events 3
|
0.00%
0/245
|
0.00%
0/255
|
|
Nervous system disorders
Sciatica
|
0.06%
2/3357 • Number of events 2
|
0.00%
0/245
|
0.00%
0/255
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Nervous system disorders
Cerebrovascular accident
|
0.03%
1/3357 • Number of events 1
|
0.41%
1/245 • Number of events 1
|
0.00%
0/255
|
|
Nervous system disorders
Convulsion
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Nervous system disorders
Epilepsy
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Nervous system disorders
Hemiparesis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Nervous system disorders
Polyneuropathy
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Nervous system disorders
Syncope
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Nervous system disorders
Transient ischaemic attack
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/3357
|
0.41%
1/245 • Number of events 1
|
0.00%
0/255
|
|
General disorders
Pyrexia
|
0.09%
3/3357 • Number of events 3
|
0.00%
0/245
|
0.00%
0/255
|
|
General disorders
Malaise
|
0.06%
2/3357 • Number of events 2
|
0.00%
0/245
|
0.00%
0/255
|
|
General disorders
Calcinosis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
General disorders
Chest pain
|
0.03%
1/3357 • Number of events 1
|
0.41%
1/245 • Number of events 1
|
0.00%
0/255
|
|
General disorders
General physical health deterioration
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
General disorders
Impaired healing
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
General disorders
Multi-organ failure
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
General disorders
Oedema peripheral
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
General disorders
Pain
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Vascular disorders
Deep vein thrombosis
|
0.12%
4/3357 • Number of events 4
|
0.00%
0/245
|
0.00%
0/255
|
|
Vascular disorders
Circulatory collapse
|
0.06%
2/3357 • Number of events 2
|
0.00%
0/245
|
0.00%
0/255
|
|
Vascular disorders
Arteriosclerosis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Vascular disorders
Hypertension
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Vascular disorders
Hypertensive crisis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Vascular disorders
Thrombophlebitis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Renal and urinary disorders
Renal failure acute
|
0.09%
3/3357 • Number of events 3
|
0.00%
0/245
|
0.00%
0/255
|
|
Renal and urinary disorders
Calculus bladder
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Renal and urinary disorders
Nephrolithiases
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Renal and urinary disorders
Renal amyloidosis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Renal and urinary disorders
Renal failure
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.06%
2/3357 • Number of events 2
|
0.00%
0/245
|
0.00%
0/255
|
|
Metabolism and nutrition disorders
Dehydration
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.06%
2/3357 • Number of events 2
|
0.00%
0/245
|
0.00%
0/255
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Hepatobiliary disorders
Cholecystitis
|
0.09%
3/3357 • Number of events 3
|
0.00%
0/245
|
0.00%
0/255
|
|
Hepatobiliary disorders
Liver disorder
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/3357
|
0.41%
1/245 • Number of events 1
|
0.00%
0/255
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3357
|
0.00%
0/245
|
0.39%
1/255 • Number of events 1
|
|
Surgical and medical procedures
Arterial bypass operation
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Surgical and medical procedures
Arthrodesis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Surgical and medical procedures
Hysterectomy
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Surgical and medical procedures
Lymphadenectomy
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Immune system disorders
Drug hypersensitivity
|
0.09%
3/3357 • Number of events 3
|
0.00%
0/245
|
0.00%
0/255
|
|
Investigations
Blood pressure increased
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Investigations
Body temperature increased
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Investigations
Transaminases increased
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Investigations
Weight increased
|
0.00%
0/3357
|
0.00%
0/245
|
0.39%
1/255 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.06%
2/3357 • Number of events 2
|
0.00%
0/245
|
0.00%
0/255
|
|
Psychiatric disorders
Panic attack
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Reproductive system and breast disorders
Endometrial hypertrophy
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Reproductive system and breast disorders
Endometriosis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Reproductive system and breast disorders
Fibrocystic breast disease
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Eye disorders
Cataract
|
0.03%
1/3357 • Number of events 2
|
0.00%
0/245
|
0.00%
0/255
|
|
Eye disorders
Open angle glaucoma
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Ear and labyrinth disorders
Conductive deafness
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.03%
1/3357 • Number of events 1
|
0.00%
0/245
|
0.00%
0/255
|
Other adverse events
| Measure |
Golimumab 50 mg Subcutaneous (GLM50-SC)
n=3357 participants at risk
Participants received GLM50-SC once monthly for a period of 6 months.
|
Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg
n=245 participants at risk
Participants received IV-GLM at a dose of 2 mg/kg at the start of Month 7, start of Month 8, and start of Month 10 if remission was not achieved at any of these IV administration visits. If remission was achieved, participants were switched subcutaneous golimumab
at a dose of 50 mg once monthly.
|
SC-GLM50
n=255 participants at risk
Participants received subcutaneous golimumab at a dose of 50 mg once monthly for a period of 6 months in Part 2 of the study.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3357
|
5.3%
13/245 • Number of events 15
|
7.1%
18/255 • Number of events 19
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3357
|
6.1%
15/245 • Number of events 17
|
2.4%
6/255 • Number of events 9
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator is granted the right to use the results of all work under this study including but not limited to, the results of tests and any raw data and statistical data generated for investigator's own teaching, research, and publication purposes only. Investigator/Institution agrees, on behalf of itself and its employees, officers, trustees, and agents, not to cause said results to be knowingly used for any commercial purpose whatsoever except as authorized by the sponsor in writing.
- Publication restrictions are in place
Restriction type: OTHER