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PoC in Rheumatoid Arthritis With Methotrexate

Primary Purpose

Rheumatoid Arthritis, NOS

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-582949
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis, NOS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Desert Medical Advances
  • Orrin M. Troum,M D
  • G. Timothy Kelly, Md
  • Health Research Of Oklahoma
  • The Arthritis Group
  • Arthritis Clinic
  • Walter F Chase Md
  • Tacoma Center For Arthritis Research Ps
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A1

P1

Arm Description

Outcomes

Primary Outcome Measures

The primary endpoint is the proportion of subjects achieving an ACR 20 at Week 12

Secondary Outcome Measures

Proportion of subjects achieving an ACR 20
Proportion of subjects schieving and ACR 50
Proportion of subjects schieving and ACR 70
Percent change from baseline to each scheduled visit in DAS28 score
Percent change from baseline to each scheduled visit in ACR scores
Proportion of subjects schieving a 20% change in assessment of pain, disease activity and fatigue
Percent change from baseline to each scheduled visit in HAQ score

Full Information

First Posted
January 18, 2008
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00605735
Brief Title
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, NOS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A1
Arm Type
Experimental
Arm Title
P1
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-582949
Other Intervention Name(s)
P38 Inflamation
Intervention Description
Tablets, Oral, 300 mg, once daily, 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets, Oral, placebo, once daily, 12 weeks
Primary Outcome Measure Information:
Title
The primary endpoint is the proportion of subjects achieving an ACR 20 at Week 12
Time Frame
at Week 12
Secondary Outcome Measure Information:
Title
Proportion of subjects achieving an ACR 20
Time Frame
at each scheduled visit
Title
Proportion of subjects schieving and ACR 50
Time Frame
at each scheduled visit
Title
Proportion of subjects schieving and ACR 70
Time Frame
at each scheduled visit
Title
Percent change from baseline to each scheduled visit in DAS28 score
Time Frame
at each scheduled visit
Title
Percent change from baseline to each scheduled visit in ACR scores
Time Frame
at each scheduled visit
Title
Proportion of subjects schieving a 20% change in assessment of pain, disease activity and fatigue
Time Frame
at each scheduled visit
Title
Percent change from baseline to each scheduled visit in HAQ score
Time Frame
at each scheduled visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Desert Medical Advances
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Orrin M. Troum,M D
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
G. Timothy Kelly, Md
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
81928
Country
United States
Facility Name
Health Research Of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
The Arthritis Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
Facility Name
Arthritis Clinic
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Walter F Chase Md
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Tacoma Center For Arthritis Research Ps
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Local Institution
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Facility Name
Local Institution
City
Ciudad Autonoma De Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
C1034ACO
Country
Argentina
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Local Institution
City
Ceske Budejovice
ZIP/Postal Code
370 01
Country
Czech Republic
Facility Name
Local Institution
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Local Institution
City
Prague 2
ZIP/Postal Code
128 50
Country
Czech Republic
Facility Name
Local Institution
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Local Institution
City
Chambray Les Tours
ZIP/Postal Code
37170
Country
France
Facility Name
Local Institution
City
Paris Cedex 14
ZIP/Postal Code
75679
Country
France
Facility Name
Local Institution
City
Cheonan
State/Province
Choong Chung Nam-Do
ZIP/Postal Code
330-721
Country
Korea, Republic of
Facility Name
Local Institution
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44200
Country
Mexico
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44500
Country
Mexico
Facility Name
Local Institution
City
Culiacan
State/Province
Sinaloa
ZIP/Postal Code
8000
Country
Mexico
Facility Name
Local Institution
City
Nuevo Leon
ZIP/Postal Code
64020
Country
Mexico
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Local Institution
City
Santiago De C.
ZIP/Postal Code
15706
Country
Spain
Facility Name
Local Institution
City
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Local Institution
City
Taichung
ZIP/Postal Code
B
Country
Taiwan
Facility Name
Local Institution
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

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PoC in Rheumatoid Arthritis With Methotrexate

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