Computer Assisted Management of Early Rheumatoid Arthritis-II: Does prednisone inhibit progression of joint damage if early RA is treated very intensively with disease modifying antirheumatic drugs (DMARDs)?
- Conditions
- Rheumatoid arthritis (RA)Musculoskeletal Diseases
- Registration Number
- ISRCTN70365169
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22393128 2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/22807253 3. 2020 results in https://pubmed.ncbi.nlm.nih.gov/32907614/ (added 11/09/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 220
1. Rheumatoid Arthritis, defined according to the revised American College of Rheumatology (ACR) criteria for Rheumatoid Arthritis
2. A disease duration of less than 1 year, estimated by the rheumatologist
3. Age >18 years
4. No previous treatment with DMARDs or oral glucocorticoids
5. Written informed consent by the patient
1. Abnormal renal function (Cockroft <75 ml/min)
2. Abnormal liver function (aspartate aminotransferase [ASAT]/alanine aminotransferase [ALAT] >2 x normal), active or recent hepatitis, cirrhosis
3. Major co-morbidities like malignancies, severe diabetic mellitus, severe infections, severe cardio and/or respiratory diseases
4. Leukopenia and/or thrombocytopenia
5. Inadequate birth control contraception, pregnancy, and/or breastfeeding
6. Treatment with cytoxic or immunosuppressive drugs within a period of 3 months prior to the study
7. Alcohol intake >2 units per day or drug abuse, presently or in the past
8. Psychiatric or mental disorders which makes adherence to the study protocol impossible
9. Taking part in another clinical trial
10. Osteoporotic vertebral fractures
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method