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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nuon Therapeutics, Inc.
• Treatments: Tranilast

Criteria

Inclusion Criteria:

• Receiving methotrexate

• Have at least 8 painful/tender and 6 swollen joints

• May be receiving oral steroids, chronic NSAIDs and/or hydroxychloroquine.

Exclusion Criteria:

• Use of any anti-arthritic treatments except those allowed in inclusion criteria

• Pregnant or nursing females

• Abnormal laboratory values

• History of clinically significant renal, hepatic dysfunction, psychiatric disorder, or alcohol/drug dependence

• Clinically significant systemic infection