Phase I/II Multiple-Dose LEA29Y vs CTLAG4Ig vs Placebo in Rheumatoid Arthritis
NCT ID: NCT00279760
Last Updated: 2016-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
210 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Belatacept
Abatacept
Eligibility Criteria
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Inclusion Criteria
* 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
* Active vasculitis
* Treatment with another investigational drug within 30 days
* History of asthma, angioedema, or anaphylaxix
18 Years
65 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Birmingham, Alabama, United States
Local Institution
Huntsville, Alabama, United States
Local Institution
Phoenix, Arizona, United States
Local Institution
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
Local Institution
Boston, Massachusetts, United States
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Duluth, Minnesota, United States
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New Brunswick, New Jersey, United States
Local Institution
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
Local Instiution
Brussels, , Belgium
Local Institution
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
Local Institution
Lyon, , France
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Montpellier, , France
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Paris, , France
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Rennes, , France
Local Institution
Strasbourg, , France
Local Institution
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
Local Institution
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
Local Institution
Birmingham, , United Kingdom
Local Institution
Cambridge, , United Kingdom
Local Institution
Leeds, , United Kingdom
Countries
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Other Identifiers
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IM103-002
Identifier Type: -
Identifier Source: org_study_id
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