Arthritis, Rheumatoid Clinical Trial
Official title:
Assessment of the Early Efficacy Response Rate of Leflunomide According to the Initial Dosing Regimen in the Treatment of Naive-DMARD (Disease Modifying Anti-Rheumatic Drug) Early RA (Rheumatoid Arthritis)-Patients
To assess the efficacy response rate at 3-months of two dosing regimen of leflunomide in
DMARDs-naive patients presenting an early-RA using American College of Rheumatology 20%
response rate.
To assess the clinical efficacy at 1-month and 3-month using complementary efficacy criteria
(ACR 50, ACR 70, DAS 28) in each group of treatment, To assess the clinical and biological
safety using standard blood monitoring, TEAED and SAE in each group of treatment, To
evaluate treatment modifications; particularity leflunomide and concomitant use of AINS and
corticoids.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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