PoC in Rheumatoid Arthritis With Methotrexate

Status:	Completed
Conditions:	Arthritis
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	March 2008
End Date:	September 2009

A Randomized, Parallel Group, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of BMS-582949 Given Orally to Subjects With Rheumatoid Arthritis Having an Inadequate Response to Methotrexate

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

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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)

We found this trial at

sites

Desert Medical Advances

Palm Desert, California 92260

from

Palm Desert, CA