None listed
Conditions
Interventions
Treatment or RA with established antirheumatic medication according to 4 different, accepted strategies.
Treatment adjustments made on the basis of threemonthly measurements of DAS (or on occurrence
Sponsors
Dutch College of Health Insurance Companies
Eligibility
Inclusion criteria
Inclusion criteria: Patients (18 years or older) with rheumatoid arthritis (ACR 1987 criteria), diagnosis since less than 2 years, previously untreated with DMARDs, with active disease (at least 6/66 swollen and at least 6/68 painfull joints, and either ESR 28 mm or more or VAS general wellbeing (by patient) of 20 mm or more).
Exclusion criteria
Exclusion criteria: 1. Previous therapy with DMARDs except for hydroxychloroquine; 2. Pregnancy or wish to become pregnant during the study, or childbearing potential without adequate contraception; 3. Concomitant treatment with another experimental drug; 4. History or presence of malignancy within the last five years; 5. Bone marrow hypoplasia; 6. elevated hepatic enzyme levels (ASAT, ALAT >3 times normal value); 7. Serum creatinine level > 150 umol/l or estimated creatinine clearance of < 75ml/min; 8. Diabetes mellitus; 9. Alcohol or drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After 2 years of follow-up: functional ability as measured by HAQ (collected by blinded research nurse) and joint damage on X-rays of hands and feet (Sharp/van der Heijde method, random in time, by 2 independent physicians, X-rays masked for center and patient identity). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Side effects; 2. Quality of life; 3. Utilities; 4. Costs. | — |
Contacts
Public ContactC.F. Allaart
Leiden University Medical Center (LUMC), Department of Rheumatology, C1-39, P.O. Box 9600
Outcome results
None listed