NCT00882024

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Nuon Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Active Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Tranilast	150 mg tranilast tablets, bid, 12 weeks
DRUG	Tranilast	75 mg tablets, bid, 12 weeks
DRUG	Placebo	Placebo tablets, bid, 12 weeks

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2009-04-16
• Last updated: 2011-01-06

Locations

32 sites across 8 countries: United States, Argentina, Bulgaria, Czechia, Germany, Mexico, Serbia, United Kingdom