ISRCTN32675862
Completed
Not Applicable
Treatment strategies for Rheumatoid Arthritis (BeSt - BehandelStrategieën in Reumatoïde Artritis)
eiden University Medical Centre (LUMC) (Netherlands)0 sites508 target enrollmentDecember 20, 2005
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rheumatoid arthritis
- Sponsor
- eiden University Medical Centre (LUMC) (Netherlands)
- Enrollment
- 508
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients (18 years or older) with rheumatoid arthritis (American College of Rheumatology \[ACR] 1987 criteria)
- •2\. Diagnosis since less than two years
- •3\. Previously untreated with DMARDs
- •4\. With active disease (at least 6/66 swollen and at least 6/68 painful joints, and either Erythrocyte Sedimentation Rate \[ESR] 28 mm or more or Visual Analogue Scale \[VAS] general well being (by patient) of 20 mm or more)
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 (Aspartate Aminotransferase \[ASAT], Alanine Aminotransferase \[ALAT] greater than three times normal value)
- •7\. Serum creatinine level greater than 150 umol/l or estimated creatinine clearance of less than 75 ml/min
- •8\. Diabetes mellitus
- •9\. Alcohol or drug abuse
Outcomes
Primary Outcomes
Not specified
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