eflunomide or methotrexate plus subcutaneous tumour necrosis factor-alpha (TNF-alpha) blocking agents in rheumatoid arthritis
- Conditions
- Musculoskeletal DiseasesRheumatoid arthritis (RA)Other rheumatoid arthritis
- Registration Number
- ISRCTN62900439
- Lead Sponsor
- St John of God Hospital (Ospedale S. Giovanni di Dio) (Italy)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 96
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method Effectiveness and safety of both groups assessed using the value of DAS 28 and DAS-CRP score every 6 months.