Rheumatoid arthritis (RA) Musculoskeletal Diseases Other rheumatoid arthritis
Conditions
Interventions
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.
Sponsors
St John of God Hospital (Ospedale S. Giovanni di Dio) (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Patients in stable therapy with LEF or MTX with a non-controlled disease activity with association therapy using a biological infusion (infliximab, rituximab, abatacept) or with a high dose of prednisone (greater than 10 mg)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Effectiveness and safety of both groups assessed using the value of DAS 28 and DAS-CRP score every 6 months. | — |
Countries
Italy
Outcome results
None listed