Leflunomide + Methotrexate in Rheumatoid Arthritis
This study has been completed.
Information provided by:
First received: November 21, 2007
Last updated: December 3, 2007
Last verified: December 2007
To determine the efficacy and safety of the combination of leflunomide and methotrexate for treating active rheumatoid arthritis (RA) in an open noncomparative multicenter trial.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Multi-Center Study to Evaluation of Leflunomide Plus Methotexate for the Treatment of Rheumatoid Arthritis in DMARDs:(Disease-Modifying Antirheumatic Drug) na¿ve or Restart (Skip DMARDs More Than 4 Weeks) Subjects.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- The primary end point was a 20% improvement in the American College of Rheumatology criteria (ACR 20) at 20 weeks [ Time Frame: 20 weeks ]
|Study Start Date:||May 2003|
|Study Completion Date:||August 2004|
concomitantly leflunomide (no loading dose, 10 mg/day) and methotrexate (starting at 7.5 mg/week and titrating up to 15 mg/week) for 20 weeks.
Other Name: ARAVA®
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