Phase I/II Multiple-Dose LEA29Y vs CTLAG4Ig vs Placebo in Rheumatoid Arthritis
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
1 other identifier
interventional
210
9 countries
60
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 rheumatoid-arthritis
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Primary Completion
Last participant's last visit for primary outcome
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
January 18, 2006
CompletedFirst Posted
Study publicly available on registry
January 20, 2006
CompletedSeptember 16, 2016
September 1, 2016
January 18, 2006
September 15, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Assess the relative safety and preliminary efficacy (clinical activity) of BMS-188667 and BMS-224818 in subjects with rheumatoid arthritis (RA)
Secondary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Local Institution
Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Los Angeles, California, United States
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San Diego, California, United States
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Miami, Florida, United States
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Chicago, Illinois, United States
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Boston, Massachusetts, United States
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Duluth, Minnesota, United States
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New Brunswick, New Jersey, United States
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New York, New York, United States
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Chapel Hill, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Portland, Oregon, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Salt Lake City, Utah, United States
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Seattle, Washington, United States
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Brussels, Belgium
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Diepenbeek, Belgium
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Ghent, Belgium
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Liège, Belgium
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Mons, Belgium
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Pellenberg, Belgium
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Edmonton, Alberta, Canada
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St. John's, Newfoundland and Labrador, Canada
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Calgary, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Sherbrook, Quebec, Canada
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Ste-Foy, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Lille, France
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Lyon, France
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Montpellier, France
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Paris, France
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Rennes, France
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Strasbourg, France
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Toulouse, France
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Berlin, Germany
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Düsseldorf, Germany
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Erlangen, Germany
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Fankfurt, Germany
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Hanover, Germany
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Leipzig, Germany
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München, Germany
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Münster, Germany
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Ratingen, Germany
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Cork, Ireland
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Dublin, Ireland
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Amsterdam, Netherlands
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Leiden, Netherlands
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Nijmegen, Netherlands
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Bern, Switzerland
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Birmingham, United Kingdom
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Cambridge, United Kingdom
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Leeds, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 18, 2006
First Posted
January 20, 2006
Primary Completion
March 1, 2002
Last Updated
September 16, 2016
Record last verified: 2016-09