PoC in Rheumatoid Arthritis With Methotrexate
- Registration Number
- NCT00605735
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description P1 Placebo - A1 BMS-582949 -
- Primary Outcome Measures
Name Time Method The primary endpoint is the proportion of subjects achieving an ACR 20 at Week 12 at Week 12
- Secondary Outcome Measures
Name Time Method Proportion of subjects achieving an ACR 20 at each scheduled visit Percent change from baseline to each scheduled visit in DAS28 score at each scheduled visit Proportion of subjects schieving a 20% change in assessment of pain, disease activity and fatigue at each scheduled visit Percent change from baseline to each scheduled visit in HAQ score at each scheduled visit Percent change from baseline to each scheduled visit in ACR scores at each scheduled visit Proportion of subjects schieving and ACR 50 at each scheduled visit Proportion of subjects schieving and ACR 70 at each scheduled visit
Trial Locations
- Locations (9)
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
🇨🇳Taoyuan, Taiwan
Desert Medical Advances🇺🇸Palm Desert, California, United States