Rheumatoid Arthritis is a chronic disease, characterized by inflammation and damage of several joints.
Conditions
Interventions
In this study the efficacy of two treatment strategies will be compared: intensive treatment versus conventional treatment with MTX.
In both treatment strategy groups, patients will be treated with M
Sponsors
Initator: UMC Utrecht, Department of Rheumatology & Clin. Immunology, on behalf of the Utrecht Rheumatoid Arthritis Cohort study group (SRU), a regional collaboration of departments of rheumatology in the region of Utrecht, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 1. RA, defined according to the revised American College of Rheumatology (ACR) criteria for RA; 2. A disease duration of less than 1 year, estimated by the rheumatologist; 3. Age > 16 years; 4. No previous treatment with DMARDs; 5. Written informed consent by the patient.
Exclusion criteria
Exclusion criteria: 1. Abnormal renal function (Cockroft 2* normal), active or recent hepatitis, cirrhose; 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 conception, pregnancy, and / or breastfeeding; 6. Chronic use of oral glucocorticoids; 7. Treatment with cytoxic or immunosuppressive drugs within a period of 3 months prior to the study; 8. Alcohol intake >2 units per day or drug abuse, presently or in the past; 9. Psychiatric or mental disorders which makes adherence to the study protocol impossible; 10. Taking part into another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients in remission, in which remission is defined as: -number of swollen joints = 0 plus at least two out of three following criteria: -number of swollen joints <3 -ESR< 20 mm/hr1st -VAS general well being < 20 mm | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Disease activity during 1 year; 2. Feasibility of computer assisted program in daily practice. | — |
Contacts
Public ContactA.C.A. Marijnissen
University Medical Center Utrecht (UMCU), Department of Rheumatology and Clinical Immunology, F02.127, P.O. Box 85500
Outcome results
None listed