Clinical trial NCT00605735: PoC in Rheumatoid Arthritis With Methotrexate
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis, NOS
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-01-31
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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)

Primary outcomes:
measure: The primary endpoint is the proportion of subjects achieving an ACR 20 at Week 12
timeFrame: at Week 12
Secondary outcomes:
measure: Proportion of subjects achieving an ACR 20
timeFrame: at each scheduled visit
measure: Proportion of subjects schieving and ACR 50
timeFrame: at each scheduled visit
measure: Proportion of subjects schieving and ACR 70
timeFrame: at each scheduled visit
measure: Percent change from baseline to each scheduled visit in DAS28 score
timeFrame: at each scheduled visit
measure: Percent change from baseline to each scheduled visit in ACR scores
timeFrame: at each scheduled visit
measure: Proportion of subjects schieving a 20% change in assessment of pain, disease activity and fatigue
timeFrame: at each scheduled visit
measure: Percent change from baseline to each scheduled visit in HAQ score
timeFrame: at each scheduled visit
Other outcomes:
Locations:
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: Santa Monica
country: United States
facility: Orrin M. Troum,M D
state: California
city: Las Vegas
country: United States
facility: G. Timothy Kelly, Md
state: Nevada
city: Oklahoma City
country: United States
facility: Health Research Of Oklahoma
state: Oklahoma
city: Philadelphia
country: United States
facility: The Arthritis Group
state: Pennsylvania
city: Jackson
country: United States
facility: Arthritis Clinic
state: Tennessee
city: Austin
country: United States
facility: Walter F Chase Md
state: Texas
city: Tacoma
country: United States
facility: Tacoma Center For Arthritis Research Ps
state: Washington
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Ciudad Autonoma De Buenos Aire
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Ceske Budejovice
country: Czech Republic
facility: Local Institution
city: Hradec Kralove
country: Czech Republic
facility: Local Institution
city: Prague 2
country: Czech Republic
facility: Local Institution
city: Bordeaux Cedex
country: France
facility: Local Institution
city: Chambray Les Tours
country: France
facility: Local Institution
city: Paris Cedex 14
country: France
facility: Local Institution
city: Cheonan
country: Korea, Republic of
facility: Local Institution
state: Choong Chung Nam-Do
city: Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Culiacan
country: Mexico
facility: Local Institution
state: Sinaloa
city: Nuevo Leon
country: Mexico
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Santiago De C.
country: Spain
facility: Local Institution
city: Vizcaya
country: Spain
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
city: Taoyuan
country: Taiwan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: