Rheumatoid Arthritis
Conditions
Interventions
10 mg of prednisolone daily vs placebo in addition to DMARDs. Two year study.
Sponsors
University Medical Center Utrecht (The Netherlands) and Abbott
Eligibility
Inclusion criteria
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; 3. Age > 18 years; 4. No previous treatment with DMARDs or oral glucocorticoids; 5. Written informed consent by the patient.
Exclusion criteria
Exclusion criteria: 1. Abnormal renal function (Cockroft 2* 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 conception, 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 into another clinical trial; 10. Osteoporotic vertebral fractures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiologic joint damage of hands and feet according to the van der Heijde modification of the Sharp scoring method. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients in remission, in which remission is defined as: 1. Number of swollen joints = 0; 2. Plus at least two out of three following criteria: 2.a Number of swollen joints <3; 2.b ESR< 20 mm/hr1st; 2.c VAS general well being < 20 mm. | — |
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