Conditions: Rheumatoid Arthritis
Keywords: RA painful joints swollen joints
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 755
Healthy volunteers: no

Brief summary:
The purpose of this study is to 1)to determine if it is better to treat all early RA patients with methotrexate in combination with hydroxychloroquine plus sulfasalazine or in combination with etanercept or reserve this treatment for patients who do not appropriately respond to methotrexate alone and 2) to determine which combination of methotrexate therapy is better

Detailed description:
The ultimate goal of RA is to eliminate symptoms, restoring the patient to normal physical, social, emotional, and vocational function, and preserving the structure and integrity of joints. While disease modifying anti-rheumatic drugs (DMARDs) have long been the cornerstone of RA therapy, the limitations of DMARDs have become increasingly apparent and investigators continue to gain insight into the pathogenesis of this disease. Recent evidence suggests that treatment earlier in the disease process with more aggressive approaches results in superior long-term outcomes compared to less intensive treatment regimens. Specifically, there is growing interest in the possibility that early "aggressive" treatment with combinations of DMARDs as initial treatment in efforts to potentially reduce the proportion of patients that advance to severe disability.

Arms:
arm 1: methotrexate (MTX) + etanercept arm 2: methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ) arm 3: methotrexate (MTX) or MTX + Etanercept arm 4: methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)

Interventions: intervention 1: methotrexate intervention 2: sulfasalazine intervention 3: hydroxychloroquine intervention 4: etanercept
Intervention descriptions: intervention 1: varies intervention 2: varies intervention 3: varies intervention 4: varies

Protocol document: