PoC in Rheumatoid Arthritis With Methotrexate

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Rheumatoid Arthritis, NOS

Intervention / Treatment
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* Drug: BMS-582949
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A1<br> | Drug: BMS-582949<br>* Tablets, Oral, 300 mg, once daily, 12 weeks<br>* Other names: P38 Inflamation;|
| Placebo Comparator: P1<br> | Drug: Placebo<br>* Tablets, Oral, placebo, once daily, 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the proportion of subjects achieving an ACR 20 at Week 12 |  | at Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving an ACR 20 |  | 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 | 
| 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 | 
| Percent change from baseline to each scheduled visit in HAQ score |  | at each scheduled visit |