Rheumatoid Arthritis, NOS
Conditions
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
Interventions
DRUGBMS-582949
Tablets, Oral, 300 mg, once daily, 12 weeks
DRUGPlacebo
Tablets, Oral, placebo, once daily, 12 weeks
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the proportion of subjects achieving an ACR 20 at Week 12 | at Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Percent change from baseline to each scheduled visit in DAS28 score | at each scheduled visit |
| Percent change from baseline to each scheduled visit in ACR scores | at each scheduled visit |
| Proportion of subjects schieving a 20% change in assessment of pain, disease activity and fatigue | at each scheduled visit |
| Proportion of subjects schieving and ACR 70 | at each scheduled visit |
| Proportion of subjects achieving an ACR 20 | at each scheduled visit |
| Proportion of subjects schieving and ACR 50 | at each scheduled visit |
| Percent change from baseline to each scheduled visit in HAQ score | at each scheduled visit |
Countries
Argentina, Czechia, France, Mexico, South Korea, Spain, Taiwan, United States
Outcome results
None listed