Conditions: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 91
Healthy volunteers: no

Brief summary:
This study involves Rheumatoid Arthritis patients in regular clinical setting who are already on etanercept treatment and are in remission or in a low disease activity (LDA) state, and is intended to identify parameters that can serve as guidance in clinical settings. This study will consider the clinical and radiographic course in subjects when etanercept treatment is tapered or discontinued, and analyze the subjects' experience of disease worsening and the predictive values of clinical parameters, serum biomarkers and imaging on the clinical and radiographic course in different treatment groups. The effect of re-treatment with etanercept at treatment failure will also be studied.

Detailed description:

Arms:
arm 1: 50mg once weekly + methotrexate arm 2: 25mg once weekly + methotrexate arm 3: once weekly + methotrexate

Interventions: intervention 1: Etanercept intervention 2: Etanercept intervention 3: Placebo
Intervention descriptions: intervention 1: 50 mg etanercept once weekly + methotrexate intervention 2: 25mg etanercept once weekly + methotrexate intervention 3: Placebo comparator once weekly + methotrexate

Protocol document: