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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

3366 participants

Primary outcome timeframe

Month 6

Results posted on

2017-04-13

Participant Flow

Participant milestones

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

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

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 6

Population: 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

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 12

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Population: 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

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 12

Population: 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

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 12

Population: 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

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)

Serious events: 203 serious events
Other events: 0 other events
Deaths: 0 deaths

Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg

Serious events: 17 serious events
Other events: 28 other events
Deaths: 0 deaths

SC-GLM50

Serious events: 7 serious events
Other events: 24 other events
Deaths: 0 deaths

Serious adverse events

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

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