Rheumatoid Arthritis, NOS Clinical Trial
Official title:
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
| Status | Completed |
| Enrollment | 121 |
| Est. completion date | September 2009 |
| Est. primary completion date | August 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution | Buenos Aires | |
| Argentina | Local Institution | Capital Federal | Buenos Aires |
| Argentina | Local Institution | Ciudad Autonoma De Buenos Aire | Buenos Aires |
| Czech Republic | Local Institution | Ceske Budejovice | |
| Czech Republic | Local Institution | Hradec Kralove | |
| Czech Republic | Local Institution | Prague 2 | |
| France | Local Institution | Bordeaux Cedex | |
| France | Local Institution | Chambray Les Tours | |
| France | Local Institution | Paris Cedex 14 | |
| Korea, Republic of | Local Institution | Cheonan | Choong Chung Nam-Do |
| Mexico | Local Institution | Culiacan | Sinaloa |
| Mexico | Local Institution | Guadalajara | Jalisco |
| Mexico | Local Institution | Guadalajara | Jalisco |
| Mexico | Local Institution | Mexico | Distrito Federal |
| Mexico | Local Institution | Nuevo Leon | |
| Spain | Local Institution | Madrid | |
| Spain | Local Institution | Santiago De C. | |
| Spain | Local Institution | Vizcaya | |
| Taiwan | Local Institution | Taichung | |
| Taiwan | Local Institution | Taoyuan | |
| United States | Walter F Chase Md | Austin | Texas |
| United States | Arthritis Clinic | Jackson | Tennessee |
| United States | G. Timothy Kelly, Md | Las Vegas | Nevada |
| United States | Health Research Of Oklahoma | Oklahoma City | Oklahoma |
| United States | Desert Medical Advances | Palm Desert | California |
| United States | The Arthritis Group | Philadelphia | Pennsylvania |
| United States | Orrin M. Troum,M D | Santa Monica | California |
| United States | Tacoma Center For Arthritis Research Ps | Tacoma | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Argentina, Czech Republic, France, Korea, Republic of, Mexico, Spain, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The primary endpoint is the proportion of subjects achieving an ACR 20 at Week 12 | at Week 12 | No | |
| Secondary | Proportion of subjects achieving an ACR 20 | at each scheduled visit | No | |
| Secondary | Proportion of subjects schieving and ACR 50 | at each scheduled visit | No | |
| Secondary | Proportion of subjects schieving and ACR 70 | at each scheduled visit | No | |
| Secondary | Percent change from baseline to each scheduled visit in DAS28 score | at each scheduled visit | No | |
| Secondary | Percent change from baseline to each scheduled visit in ACR scores | at each scheduled visit | No | |
| Secondary | Proportion of subjects schieving a 20% change in assessment of pain, disease activity and fatigue | at each scheduled visit | No | |
| Secondary | Percent change from baseline to each scheduled visit in HAQ score | at each scheduled visit | No |