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

This study has been completed.
Information provided by:
Bristol-Myers Squibb Identifier:
First received: January 18, 2006
Last updated: September 15, 2016
Last verified: September 2016
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

Condition Intervention Phase
Rheumatoid Arthritis Drug: Belatacept Drug: Abatacept Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

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

Estimated Enrollment: 210
Primary Completion Date: March 2002 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00279760

  Show 60 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information: Identifier: NCT00279760     History of Changes
Other Study ID Numbers: IM103-002
Study First Received: January 18, 2006
Last Updated: September 15, 2016

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on September 21, 2017