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Safety and Efficacy Study of Tranilast in Patients With Active Rheumatoid Arthritis (RA)

Active Rheumatoid Arthritis Clinical Trial

Official title:
A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast With Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients With Active Rheumatoid Arthritis (RA)

Clinical Trial Summary

The purpose of this study is to evaluate whether tranilast at two different dosages compared to placebo is effective in patients with active RA when added to continuing methotrexate (MTX) therapy.

Clinical Trial Description

The primary objective of this study is to assess the efficacy and safety of two different doses of tranilast as determined by ACR20 response at 12 weeks. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00882024
Study type Interventional
Source Nuon Therapeutics, Inc.
Contact
Status Completed
Phase Phase 2
Start date March 2009
Completion date December 2010
View Details
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