Conditions: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 300
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the efficacy of etanercept with usual disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe rheumatoid arthritis (RA) over 16 weeks in the Asia Pacific region.

Detailed description:

Arms:
arm 1: Etanercept + Methotrexate arm 2: DMARD therapy Methotrexate + Sulfasalazine/Hydroxychloroquine/Leflunomide

Interventions: intervention 1: Etanercept , Methotrexate intervention 2: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide
Intervention descriptions: intervention 1: * Etanercept: 25 mg twice weekly over 16 weeks, SC
* Methotrexate: \> 7.5 mg/week and no more than 25 mg/week, PO intervention 2: * Methotrexate: at least 7.5 mg/wk and not more than 25 mg/wk.;PO
* Sulfasalazine: Start treatment w/500 mg daily for 1 wk, thereafter increase dose by 1 tab each wk to a max of 3 g/day;PO
* Hydroxychloroquine:400 mg daily in divided dose, may be reduced to 200 mg. Max: 6.5 mg/kg/day
* Leflunomide: Initially, loading dose 100 mg daily for 3 days. Maintenance: 20 mg daily

Protocol document: