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

Completed · Phase 2 · Has a placebo group

Conditions studied: Active Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT00882024

Run by

Nuon Therapeutics, Inc.

People needed

250

Starts

2009-03-01

Expected to finish

2010-12-01

Last updated by the study team

2011-01-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Receiving methotrexate
• Have at least 8 painful/tender and 6 swollen joints
• May be receiving oral steroids, chronic NSAIDs and/or hydroxychloroquine.

You may not qualify if…

• 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

Where it is running

• Study site — Mesa, Arizona, United States
• Study site — Paradise Valley, Arizona, United States
• Study site — La Jolla, California, United States
• Study site — San Diego, California, United States
• Study site — Aventura, Florida, United States
• Study site — Frederick, Maryland, United States
• Study site — Lansing, Michigan, United States
• Study site — Hickory, North Carolina, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Capital Federal, Buenos Aires, Argentina
• Study site — Luján, Buenos Aires, Argentina
• Study site — Quilmes, Buenos Aires, Argentina
• Study site — Rosario, Santa Fe Province, Argentina
• Study site — Plovdiv, Bulgaria
• Study site — Sofia, Bulgaria
• Study site — Brno-Bohunice, Czechia
• Study site — Ostrava-Hlucin, Czechia
• Study site — Prague, Czechia
• Study site — Zlín, Czechia
• Study site — Hamburg, Germany
• Study site — Ludwigsfelde, Germany
• Study site — Naumburg, Germany
• Study site — Osnabrück, Germany
• Study site — Ratingen, Germany
• Study site — Wiesbaden, Germany

Full record on ClinicalTrials.gov

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