PoC in Rheumatoid Arthritis With Methotrexate

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis, NOS

Treatments: Drug: BMS-582949; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00605735

IM119-015

Details and patient eligibility

About

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

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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121 participants in 2 patient groups, including a placebo group

A1

Experimental group

Treatment:

Drug: BMS-582949

P1

Placebo Comparator group

Treatment:

Drug: Placebo