Computer Assisted Management of Early Rheumatoid Arthritis-II: Does prednisone inhibit progression of joint damage if early RA is treated very intensively with DMARDs?
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NL-OMON24306
- Lead Sponsor
- niversity Medical Center Utrecht (The Netherlands) and Abbott
- Brief Summary
Research based on:<br> Everdingen AA van, Jacobs JWG, Reesema DR van, Bijlsma JWJ. Low-dose prednisone therapy for patients with early active rheumatoid arthritis: clinical efficacy, disease-modifying properties, and side effects. A randomized, double-blind placebo-controlled clinical trial. Ann Intern Med 2002: 136: 1-12.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 220
Inclusion Criteria
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;
Exclusion Criteria
1. Abnormal renal function (Cockroft < 75 ml/min);
2. Abnormal liver function (ASAT/ALAT > 2* normal), active or recent hepatitis, cirrhosis;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Radiologic joint damage of hands and feet according to the van der Heijde modification of the Sharp scoring method.
- Secondary Outcome Measures
Name Time Method umber of patients in remission, in which remission is defined as:<br /><br>1. Number of swollen joints = 0;<br /><br>2. Plus at least two out of three following criteria:<br /><br>2.a Number of swollen joints <3;<br /><br>2.b ESR< 20 mm/hr1st;<br /><br>2.c VAS general well being < 20 mm.