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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00975130
First received: August 20, 2009
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

Part 1 of this trial will assess the safety and effectiveness of subcutaneous (SC) golimumab administered by autoinjector once monthly, when combined with different disease-modifying antirheumatic drug (DMARD) regimens used in daily rheumatology practice. Subsequently, Part 2 will study if a strategy of intravenous (IV) golimumab to induce remission followed by SC golimumab to retain remission is superior to continuing a SC regimen.


Condition Intervention Phase
Arthritis, Rheumatoid
Biological: SC golimumab
Biological: IV golimumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    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

  • 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 [ Time Frame: Start of Month 11, End of Month 12 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in the Number of Swollen Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in the Number of Swollen Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in the Number of Swollen Joints by Duration of Disease at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in the Number of Swollen Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in the Number of Swollen Joints by Baseline Rheumatoid Factor (RF) Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in the Number of Tender Joints by Concomitant MTX Dose at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in the Number of Tender Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in the Number of Tender Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in the Number of Tender Joints by Duration of Disease at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in the Number of Tender Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in the Number of Tender Joints by Baseline RF Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in the Number of Tender Joints by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in the Number of Tender Joints by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in Participant Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in the Erythrocyte Sedimentation Rate (ESR) by Concomitant MTX Dose at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in ESR by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    The mean change from baseline in serum ESR by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6.

  • Mean Change From Baseline in ESR by the Number of DMARD Failures at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in ESR by Duration of Disease at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in ESR by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in ESR by Baseline RF Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in ESR by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in ESR by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in ESR by Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in ESR by Physician Experience Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in ESR by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in C-Reactive Protein (CRP) by Concomitant MTX Dose at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in CRP by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    The mean change from baseline in serum CRP by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6.

  • Mean Change From Baseline in CRP by the Number of DMARD Failures at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in CRP by Duration of Disease at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in CRP by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in CRP by Baseline RF Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in CRP by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in CRP by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in CRP by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in CRP by Physician Experience Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in CRP by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in DAS28-ESR Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in DAS28-ESR Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in DAS28-ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in DAS28-ESR Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in DAS28-ESR Score by Duration of Disease at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in DAS28-ESR Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in DAS28-ESR Score by Baseline RF Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in DAS28-ESR Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in DAS28-ESR Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in DAS28-ESR Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in DAS28-ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in DAS28-CRP Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in DAS28-CRP Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in DAS28-CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in DAS28-CRP Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in DAS28-CRP Score by Duration of Disease at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in DAS28-CRP Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in DAS28-CRP Score by Baseline RF Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in DAS28-CRP Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in DAS28-CRP Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in DAS28-CRP Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in DAS28-CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in the Simplified Disease Activity Index (SDAI) Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in SDAI Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in SDAI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in SDAI by the Number of DMARD Failures at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in SDAI by Duration of Disease at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in SDAI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in SDAI by Baseline RF Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in SDAI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in SDAI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in SDAI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in SDAI by Physician Experience Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in SDAI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in SDAI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Who Achieved DAS28-ESR EULAR Response [ Time Frame: Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Who Achieved DAS28-CRP EULAR Response [ Time Frame: Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    DAS28-CRP EULAR response is defined as a good or moderate response that results in a DAS28-CRP >=0.6.

  • Number of Participants Achieving Low Disease Activity and Remission at Month 2, Month 4, and Month 6 [ Time Frame: Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in HAQ-DI by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in HAQ-DI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in HAQ-DI by the Number of DMARD Failures at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in HAQ-DI by Duration of Disease at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in HAQ-DI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in HAQ-DI by Baseline RF Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in HAQ-DI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in HAQ-DI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in HAQ-DI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in HAQ-DI by Physician Experience Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in HAQ-DI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in HAQ-DI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Who Achieved Minimal or Absence of Functional Impairment [ Time Frame: Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in EQ-5D by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in EQ-5D by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in EQ-5D by the Number of DMARD Failures at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in EQ-5D by Duration of Disease at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in EQ-5D by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in EQ-5D by Baseline RF Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in EQ-5D by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in EQ-5D by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in EQ-5D by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in EQ-5D by Physician Experience Level at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in EQ-5D by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in EQ-5D by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 [ Time Frame: Baseline, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With a Participant Acceptable Symptom State (PASS) at Month 4, Month 6, and Month 8 [ Time Frame: Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Area Under the DAS28-ESR Curve From Study Month 6 to Month 12 [ Time Frame: End of Month 6, End of Month 12 ] [ Designated as safety issue: No ]

    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.


  • Percentage of Participants Achieving Remission [ Time Frame: Start of Month 8, Start of Month 9, Start of Month 10, Start of Month 11, End of Month 12 ] [ Designated as safety issue: No ]
    Remission was defined as achievement of a DAS28-ESR < 2.6.


Enrollment: 3366
Study Start Date: September 2009
Study Completion Date: February 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SC-GLM50
In Part 1 of the study, participants received subcutaneous golimumab treatment at a dose of 50 mg once monthly for 6 months in combination with background DMARD treatment.
Biological: SC golimumab
Subcutaneous golimumab at a dose of 50 mg administered once monthly.
Other Name: SCH 900259, subcutaneous
Experimental: IV GLM 2 mg/kg + GLM50-SC
After 6 months of treatment in study Part 1, participants with good or moderate response but not in remission will receive intravenous (IV) golimumab at a dose of 2 mg/kg once monthly for a period of 6 months or until remission is achieved. Participants will receive IV GLM at a dose of 2 mg/kg at the start of Month 7, and then at the start of Month 8 and Month 10 if the subject has not achieved remission at any of these IV administration visits. If remission is achieved, participants were switched to subcutaneous golimumab at a dose of 50 mg once monthly until study end, in combination with background DMARD treatment.
Biological: SC golimumab
Subcutaneous golimumab at a dose of 50 mg administered once monthly.
Other Name: SCH 900259, subcutaneous
Biological: IV golimumab
Intravenous golimumab administered up to 3 times (month 7, 8, 10) during a period of 6 months at a dose of 2 mg/kg of body weight.
Other Name: SCH 900259, intravenous
Experimental: GLM50-SC
After 6 months of treatment in study Part 1, participants with good or moderate response but not in remission will receive subcutaneous golimumab at a dose of 50 mg once monthly for a period of 6 months, in combination with background DMARD treatment.
Biological: SC golimumab
Subcutaneous golimumab at a dose of 50 mg administered once monthly.
Other Name: SCH 900259, subcutaneous

Detailed Description:

Participants who had a good or moderate European League Against Rheumatism (EULAR) response but not achieve remission at the end of Part 1 were invited to participate in Part 2 and were randomized to either intravenous golimumab (IV GLM) + subcutaneous golimumab (SC GLM) or SC GLM alone.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For Part 1:

  • Age >=18 years, either sex, any race.
  • Diagnosis of RA according to the 1987 revised American College of Rheumatology (ACR) criteria.
  • Active disease despite DMARD treatment
  • Subject must be taking at least one of the allowed DMARDs, and must be able to continue with it during the trial.
  • Eligibility for anti tumor necrosis factor (TNF) use according to the following criteria:

    • Participant must have failed conventional treatment according to the investigator's opinion OR local guidelines.
    • Local guidelines regarding safety screening of anti TNF candidates (ie, tuberculosis [TB] screening and other safety screening such as vaccination, if applicable) must be met. Chest X-ray and either a PPD skin test or QuantiFERON®-TB Gold test are also required.
    • Anamnesis and physical examination must make the participant eligible for anti TNF use and trial participation according to the investigator's judgment.

For Part 2:

  • Participant must have completed Part 1 of this trial.
  • Participant must have:

    • good or moderate response to SC golimumab at the end of Month 6 compared to Baseline, AND.
    • no DAS28 ESR remission.
  • Both the investigator and the subject must agree to switch the participant's treatment to IV administration as may be required in Part 2 of this trial.
  • The investigator must judge that no safety events (eg, serious adverse events [SAEs], serious infections, marked injection-site reactions or intolerance to drug) have occurred that could reoccur or aggravate with increased drug exposure.

Exclusion Criteria:

  • History of biologic drug use for RA.
  • Evidence of active TB. or latent TB that is untreated.
  • Moderate to severe heart failure
  • Certain inflammatory rheumatic disease other than RA or certain systemic inflammatory condition
  • Allergy to latex
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00975130     History of Changes
Other Study ID Numbers: P06129, 2009-011137-26, CTRI/2009/091/000883
Study First Received: August 20, 2009
Results First Received: July 18, 2012
Last Updated: February 14, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014