Leflunomide EfficAcy Response Related to Dosing Regimen in Early Rheumatoid Arthritis
Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
Participant gender:
Summary
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.