Back to resultsPhase I/II Multiple-Dose LEA29Y vs CTLAG4Ig vs Placebo in Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Belatacept
Abatacept
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria: Diagnosis of RA < 5 years Functional class I, II, or II as defined by the American College of Rheumatology (ACR) criteria. Must have failed at least 1 Disease Modifying Anit-Rheumatic Drug (DMARD) Joint count of 10 or more swollen and 12 or more tender. Erythrocyte Sedimentation Rate (ESR) > - 28mm/rr or norning stiffness > - 45 minutes. Exclusion Criteria: Women and men who are not willing to use an accepted form of contraception. Active vasculitis Treatment with another investigational drug within 30 days History of asthma, angioedema, or anaphylaxix
Sites / Locations
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Outcomes
Primary Outcome Measures
Assess the relative safety and preliminary efficacy (clinical activity) of BMS-188667 and BMS-224818 in subjects with rheumatoid arthritis (RA)
Secondary Outcome Measures
Assess the immunogenicity of BMS-188667 and BMS-224818 in subjects with RA, and in a site specific substudy to the protocol, the pharmacokinetics (PK) and pharmacodynamics (PD) of BMS-188667 and BMS-224818 in subjects with RA
Full Information
NCT ID
NCT00279760
First Posted
January 18, 2006
Last Updated
September 15, 2016
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT00279760
Brief Title
Phase I/II Multiple-Dose LEA29Y vs CTLAG4Ig vs Placebo in Rheumatoid Arthritis
Official Title
A Pilot, Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Preliminary Clinical Activity and Immunogenicity of Multiple Doses of LEA29Y and CTLA4Ig Administered Intravenously to Subjects With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
March 2002 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. Study Description
Brief Summary
This randomized, double-blind, placebo controlled, parallel and multiple dose study provided safety, preliminary efficacy, and immunogenicity information about the use of BMS-188667 and BMS-224818 in subjects with RA
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
210 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Belatacept
Intervention Type
Drug
Intervention Name(s)
Abatacept
Primary Outcome Measure Information:
Title
Assess the relative safety and preliminary efficacy (clinical activity) of BMS-188667 and BMS-224818 in subjects with rheumatoid arthritis (RA)
Secondary Outcome Measure Information:
Title
Assess the immunogenicity of BMS-188667 and BMS-224818 in subjects with RA, and in a site specific substudy to the protocol, the pharmacokinetics (PK) and pharmacodynamics (PD) of BMS-188667 and BMS-224818 in subjects with RA
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of RA < 5 years
Functional class I, II, or II as defined by the American College of Rheumatology (ACR) criteria.
Must have failed at least 1 Disease Modifying Anit-Rheumatic Drug (DMARD)
Joint count of 10 or more swollen and 12 or more tender.
Erythrocyte Sedimentation Rate (ESR) > - 28mm/rr or norning stiffness > - 45 minutes.
Exclusion Criteria:
Women and men who are not willing to use an accepted form of contraception.
Active vasculitis
Treatment with another investigational drug within 30 days
History of asthma, angioedema, or anaphylaxix
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
Local Institution
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Local Institution
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
Local Institution
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Local Institution
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Local Institution
City
Los Angeles
State/Province
California
Country
United States
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Local Institution
City
San Diego
State/Province
California
Country
United States
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Local Institution
City
Miami
State/Province
Florida
Country
United States
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Local Institution
City
Chicago
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Illinois
Country
United States
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Local Institution
City
Boston
State/Province
Massachusetts
Country
United States
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Local Institution
City
Duluth
State/Province
Minnesota
Country
United States
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Local Institution
City
New Brunswick
State/Province
New Jersey
Country
United States
Facility Name
Local Institution
City
New York
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
Local Institution
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Local Institution
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Local Institution
City
Portland
State/Province
Oregon
Country
United States
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Local Institution
City
Nashville
State/Province
Tennessee
Country
United States
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Local Institution
City
Dallas
State/Province
Texas
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United States
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Local Institution
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Local Institution
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Local Instiution
City
Bruxelles
Country
Belgium
Facility Name
Local Institution
City
Diepenbeek
Country
Belgium
Facility Name
Local Institution
City
Gent
Country
Belgium
Facility Name
Local Institution
City
Liege 1
Country
Belgium
Facility Name
Local Institution
City
Mons
Country
Belgium
Facility Name
Local Institution
City
Pellenberg
Country
Belgium
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Local Institution
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
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Local Institution
City
Calgary
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Ontario
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Canada
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Local Institution
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
Country
Canada
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Local Institution
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Montreal
State/Province
Quebec
Country
Canada
Facility Name
Local Institution
City
Sherbrook
State/Province
Quebec
Country
Canada
Facility Name
Local Institution
City
Ste-Foy
State/Province
Quebec
Country
Canada
Facility Name
Local Institution
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
Local Institution
City
Lille
Country
France
Facility Name
Local Institution
City
Lyon
Country
France
Facility Name
Local Institution
City
Montpellier
Country
France
Facility Name
Local Institution
City
Paris
Country
France
Facility Name
Local Institution
City
Rennes
Country
France
Facility Name
Local Institution
City
Strasbourg
Country
France
Facility Name
Local Institution
City
Toulouse
Country
France
Facility Name
Local Institution
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Berlin
Country
Germany
Facility Name
Local Institution
City
Duesseldorf
Country
Germany
Facility Name
Local Institution
City
Erlangen
Country
Germany
Facility Name
Local Institution
City
Fankfurt
Country
Germany
Facility Name
Local Institution
City
Hannover
Country
Germany
Facility Name
Local Institution
City
Leipzig
Country
Germany
Facility Name
Local Institution
City
Muenchen
Country
Germany
Facility Name
Local Institution
City
Muenster
Country
Germany
Facility Name
Local Institution
City
Ratingen
Country
Germany
Facility Name
Local Institution
City
Cork
Country
Ireland
Facility Name
Local Institution
City
Dublin
Country
Ireland
Facility Name
Local Institution
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Amsterdam
Country
Netherlands
Facility Name
Local Institution
City
Leiden
Country
Netherlands
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Local Institution
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Nijmegen
Country
Netherlands
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Bern
Country
Switzerland
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Local Institution
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Birmingham
Country
United Kingdom
Facility Name
Local Institution
City
Cambridge
Country
United Kingdom
Facility Name
Local Institution
City
Leeds
Country
United Kingdom
12. IPD Sharing Statement
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Phase I/II Multiple-Dose LEA29Y vs CTLAG4Ig vs Placebo in Rheumatoid Arthritis
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