Phase I/II Multiple-Dose LEA29Y vs CTLAG4Ig vs Placebo in Rheumatoid Arthritis

NCT ID: NCT00279760

Last Updated: 2016-09-16

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Belatacept

Intervention Type DRUG

Abatacept

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

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

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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

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Countries

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United States Belgium Canada France Germany Ireland Netherlands Switzerland United Kingdom

Other Identifiers

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IM103-002

Identifier Type: -

Identifier Source: org_study_id

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