Conditions: Rheumatoid Arthritis
Keywords: RA Enbrel DMARD Joint Count Rheumatoid Arthritis Etanercept disease modifying anti-rheumatic drug
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 210
Healthy volunteers: no

Brief summary:
This study is designed to evaluate the effectiveness of adding etanercept to disease modifying anti-rheumatic drug (DMARD) therapy in patients with moderately active Rheumatoid Arthritis (RA).

Detailed description:

Arms:
arm 1: Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.

All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period. arm 2: Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks.

All participants continued their DMARD treatment throughout the 24-week study period.

Interventions: intervention 1: etanercept intervention 2: Placebo intervention 3: DMARD Therapy
Intervention descriptions: intervention 1: Administered by subcutaneous injection once weekly. intervention 2: Placebo subcutaneous injection intervention 3: Standard-of-care DMARD therapy, including methotrexate, sulfasalazine, leflunomide, minocycline, and/or hydroxychloroquine

Protocol document: