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Clinical Trials/ISRCTN32675862
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.

Registry
who.int
Start Date
December 20, 2005
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional

Investigators

Sponsor
eiden University Medical Centre (LUMC) (Netherlands)

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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