Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2)

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

Time frame: 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.

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.

Time frame: 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 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.

Time frame: 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 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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 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).

Time frame: 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 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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 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).

Time frame: 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 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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 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).

Time frame: 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 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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 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).

Time frame: 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 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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 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).

Time frame: 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 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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 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).

Time frame: 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 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.