NCT00596206

Leflunomide EfficAcy Response Related to Dosing Regimen in Early Rheumatoid Arthritis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	leflunomide	20 or 100 mg per os, Film coated tablet, for 3 days + matching placebo, then 20 mg once daily for 3 months

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2008-01-16
• Last updated: 2010-10-13

Locations

5 sites across 5 countries: Czechia, Italy, Portugal, Romania, South Korea