Status:
COMPLETED
Safety and Efficacy Study of Tranilast in Patients With Active Rheumatoid Arthritis (RA)
Lead Sponsor:
Nuon Therapeutics, Inc.
Conditions:
Active Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- Receiving methotrexate
- Have at least 8 painful/tender and 6 swollen joints
- May be receiving oral steroids, chronic NSAIDs and/or hydroxychloroquine.
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00882024
Start Date
March 1 2009
End Date
December 1 2010
Last Update
January 6 2011
Active Locations (32)
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1
Mesa, Arizona, United States
2
Paradise Valley, Arizona, United States
3
La Jolla, California, United States
4
San Diego, California, United States