PoC in Rheumatoid Arthritis With Methotrexate

Phase 2

Completed

• Conditions: Rheumatoid Arthritis, NOS
• Interventions: Drug: Placebo; Drug: BMS-582949

• 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

Study Timeline

• Study First Submitted: 2008-01-18
• Study First Submitted QC: 2008-01-18
• Study First Posted: 2008-01-31
• Study Start: 2008-03
• Primary Completion: 2009-08
• Study Completion: 2009-09
• Disposition First Submitted: 2010-09-10
• Disposition First Submitted QC: 2010-09-13
• Disposition First Posted: 2010-09-15
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-23
• Last Update Posted: 2015-10-12

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)

G. Timothy Kelly, Md; 🇺🇸 Las Vegas, Nevada, United States

Local Institution; 🇨🇳 Taoyuan, Taiwan

The Arthritis Group; 🇺🇸 Philadelphia, Pennsylvania, United States

Orrin M. Troum,M D; 🇺🇸 Santa Monica, California, United States

Walter F Chase Md; 🇺🇸 Austin, Texas, United States

Desert Medical Advances; 🇺🇸 Palm Desert, California, United States

Health Research Of Oklahoma; 🇺🇸 Oklahoma City, Oklahoma, United States

Tacoma Center For Arthritis Research Ps; 🇺🇸 Tacoma, Washington, United States

Arthritis Clinic; 🇺🇸 Jackson, Tennessee, United States