Leflunomide or methotrexate plus subcutaneous tumour necrosis factor-alpha (TNF-alpha) blocking agents in rheumatoid arthritis

INTERVENTION: Leflunomide 20 mg/ day or methotrexate 10‐15 mg/ once week plus etanercept 50 mg /once week or adalimumab 14 mg/ every other week. Total duration 104 weeks. CONDITION: Rheumatoid arthritis (RA) ; Musculoskeletal Diseases ; Other rheumatoid arthritis PRIMARY OUTCOME: All patients were assessed at the beginning of the study (baseline) and every 3 months for 2 years by measuring 28‐item Disease Activity Scale (DAS‐28) score and DAS‐CRP score. Remission was considered for a value less than 2.6 while low disease activity was considered for a value between 2.6 and 3.2. SECONDARY OUTCOME: Effectiveness and safety of both groups assessed using the value of DAS 28 and DAS‐CRP score every 6 months. INCLUSION CRITERIA: 1. Adult patients (aged between 26 and 86 years, either sex) with active rheumatoid arthritis (RA) defined as follows: greater than or equal to 6 swollen joints and greater than or equal to 6 painful joints and at least two of the following: 1.1. Morning stiffness greater than or equal to 45 minutes 1.2. Erythrocyte sedimentation rate (ESR) greater than or equal to 28 mm/first hour 1.3. C‐reactive protein (CRP) greater than or equal to 2.0 mg/dL 2. Stabilised low‐dose of prednisone (less than or equal to 7.5 mg ) 3. Stable dose of non‐steroidal anti‐inflammatory drugs (NSAIDs) 4. Intrarticular injections of corticosteroids not allowed