PoC in Rheumatoid Arthritis With Methotrexate

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis, NOS

In brief

The purpose of this study is to find out if 300 mg of BMS-582949 given once daily will be more effective than placebo after 12 weeks of treatment in subjects with rheumatoid arthritis who are also taking methotrexate

Key facts

Study ID

NCT00605735

Run by

Bristol-Myers Squibb

People needed

121

Starts

2008-03-01

Expected to finish

2009-09-01

Last updated by the study team

2015-10-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have a diagnosis of RA for at least 6 months
• Must be taking methotrexate for at least 3 months \& on a stable dose of 7.5-30 mg weekly) for 4 weeks before dosing with study medication
• Must have at least 6 swollen and at least 8 tender joints
• CRP above upper limit of normal or ESR > 28 mm/hr
• Must wash-out (stop taking) other immunosuppressant medications to treat RA (except for methotrexate) before dosing with study medication

You may not qualify if…

• Any infection including TB, HIV, Hepatitis B or C
• Recent infection requiring antibiotics within 4 weeks
• History of gastrointestinal disease (such as GERD, gastrointestinal ulcers, heartburn) requiring medical or surgical treatment within 3 months
• Chronic use of proton pump inhibitors (such as Losec, Prilosec, Prevacid, Nexium), H2 blockers (such as Tagamet, Pepcid, Zantac, Axid) or antacids (such as Mylanta, Maalox)

Where it is running

• Desert Medical Advances — Palm Desert, California, United States
• Orrin M. Troum,M D — Santa Monica, California, United States
• G. Timothy Kelly, Md — Las Vegas, Nevada, United States
• Health Research Of Oklahoma — Oklahoma City, Oklahoma, United States
• The Arthritis Group — Philadelphia, Pennsylvania, United States
• Arthritis Clinic — Jackson, Tennessee, United States
• Walter F Chase Md — Austin, Texas, United States
• Tacoma Center For Arthritis Research Ps — Tacoma, Washington, United States
• Local Institution — Buenos Aires, Buenos Aires, Argentina
• Local Institution — Capital Federal, Buenos Aires, Argentina
• Local Institution — Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
• Local Institution — České Budějovice, Czechia
• Local Institution — Hradec Králové, Czechia
• Local Institution — Prague, Czechia
• Local Institution — Bordeaux, France
• Local Institution — Chambray-lès-Tours, France
• Local Institution — Paris, France
• Local Institution — Guadalajara, Jalisco, Mexico
• Local Institution — Guadalajara, Jalisco, Mexico
• Local Institution — Mexico City, Mexico City, Mexico
• Local Institution — Nuevo León, Nuevo León, Mexico
• Local Institution — Culiacán, Sinaloa, Mexico
• Local Institution — Cheonan, Choong Chung Nam-Do, South Korea
• Local Institution — Madrid, Spain
• Local Institution — Santiago de C., Spain

Full record on ClinicalTrials.gov

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