Clinical and ultrasonographic efficacy of low-dose prednisone co-treatment versus methotrexate alone in early rheumatoid arthritis
Completed
- Conditions
- Rheumatoid arthritisMusculoskeletal Diseases
- Registration Number
- ISRCTN24868111
- Lead Sponsor
- IRCCS Policlinico San Matteo (Italy)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 220
Inclusion Criteria
1. Fulfilment of the American College of Rheumatology (ACR) classification criteria for RA
2. Aged greater than 18 years, either sex
3. Symptom duration less than 12 months
Exclusion Criteria
Contraindications for glucocorticoid therapy, including uncontrolled diabetes and previous fragility osteoporotic fractures
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Clinical remission (DAS<1.6), measured at 12 months<br>2. Ultrosonographic remission (PD=0), measured at 12 months
- Secondary Outcome Measures
Name Time Method measured at 12 months:<br>1. Mean decrease in swollen joint count<br>2. Tender joint count<br>3. ESR<br>4. CRP<br>5. Power Doppler scores