ISRCTN72821021
Completed
Not Applicable
Quality management: improvement of patient care in recently diagnosed rheumatoid arthritis
niversity Medical Centre Utrecht (UMCU) (Netherlands)0 sites301 target enrollmentDecember 20, 2005
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rheumatoid arthritis
- Sponsor
- niversity Medical Centre Utrecht (UMCU) (Netherlands)
- Enrollment
- 301
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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\. Aged greater than 16 years
- •4\. No previous treatment with Disease Modifying Anti\-Rheumatic Drugs (DMARDs)
- •5\. Written informed consent by the patient
Exclusion Criteria
- •1\. Abnormal renal function (Cockroft less than 75 ml/min)
- •2\. Abnormal liver function (Aspartate Aminotransferase \[ASAT]/Alanine Aminotransferase \[ALAT] greater than 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 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 greater than 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
Outcomes
Primary Outcomes
Not specified
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