PoC in Rheumatoid Arthritis With Methotrexate

Bristol-Myers Squibb121 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

121

Conditions

Rheumatoid Arthritis, NOS

Interventions

BMS-582949DRUG

Tablets, Oral, 300 mg, once daily, 12 weeks

PlaceboDRUG

Tablets, Oral, placebo, once daily, 12 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (28)

Desert Medical Advances

Palm Desert, California, United States

Outcomes

Primary Outcomes

The primary endpoint is the proportion of subjects achieving an ACR 20 at Week 12

Time frame: at Week 12