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

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ClinicalTrials.gov Identifier: NCT00279760
Recruitment Status : Completed
First Posted : January 20, 2006
Last Update Posted : September 16, 2016
Sponsor:
Information provided by:
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Belatacept Drug: Abatacept Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 210 participants
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
Actual Primary Completion Date : March 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept




Primary Outcome Measures :
  1. Assess the relative safety and preliminary efficacy (clinical activity) of BMS-188667 and BMS-224818 in subjects with rheumatoid arthritis (RA)

Secondary Outcome Measures :
  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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00279760


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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
ClinicalTrials.gov Identifier: NCT00279760     History of Changes
Other Study ID Numbers: IM103-002
First Posted: January 20, 2006    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents