CClinicalTrials.gg
CompletedNCT00279760Updated Sep 16, 2016

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

A Phase 1/2 interventional study of Belatacept and Abatacept in Rheumatoid Arthritis, sponsored by Bristol-Myers Squibb. Completed at 60 sites in 9 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-09-16.

Sponsored by Bristol-Myers Squibb · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Rheumatoid Arthritis
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 210 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
210 participants

Interventions

  • DrugBelatacept
  • DrugAbatacept
06

What researchers measure

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

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Study locations

60 sites
  • Local Institution
    Birmingham, Alabama, United States
  • Local Institution
    Huntsville, Alabama, United States
  • Local Institution
    Phoenix, Arizona, United States
  • Local Institution
    Tucson, Arizona, United States
  • Local Institution
    Los Angeles, California, United States
  • Local Institution
    San Diego, California, United States
  • Local Institution
    Miami, Florida, United States
  • Local Institution
    Chicago, Illinois, United States
  • Local Institution
    Boston, Massachusetts, United States
  • Local Institution
    Duluth, Minnesota, United States
  • Local Institution
    New Brunswick, New Jersey, United States
  • Local Institution
    New York, New York, United States
  • Local Institution
    Chapel Hill, North Carolina, United States
  • Local Institution
    Cincinnati, Ohio, United States
  • Local Institution
    Cleveland, Ohio, United States
  • Local Institution
    Portland, Oregon, United States
  • Local Institution
    Nashville, Tennessee, United States
  • Local Institution
    Dallas, Texas, United States
  • Local Institution
    Salt Lake City, Utah, United States
  • Local Institution
    Seattle, Washington, United States
  • Local Instiution
    Bruxelles, Belgium
  • Local Institution
    Diepenbeek, Belgium
  • Local Institution
    Gent, Belgium
  • Local Institution
    Liege 1, Belgium
  • Local Institution
    Mons, Belgium
  • Local Institution
    Pellenberg, Belgium
  • Local Institution
    Edmonton, Alberta, Canada
  • Local Institution
    St. John's, Newfoundland and Labrador, Canada
  • Local Institution
    Calgary, Ontario, Canada
  • Local Institution
    Ottawa, Ontario, Canada
  • Local Institution
    Toronto, Ontario, Canada
  • Local Institution
    Montreal, Quebec, Canada
  • Local Institution
    Sherbrook, Quebec, Canada
  • Local Institution
    Ste-Foy, Quebec, Canada
  • Local Institution
    Saskatoon, Saskatchewan, Canada
  • Local Institution
    Lille, France
  • Local Institution
    Lyon, France
  • Local Institution
    Montpellier, France
  • Local Institution
    Paris, France
  • Local Institution
    Rennes, France
  • Local Institution
    Strasbourg, France
  • Local Institution
    Toulouse, France
  • Local Institution
    Berlin, Germany
  • Local Institution
    Duesseldorf, Germany
  • Local Institution
    Erlangen, Germany
  • Local Institution
    Fankfurt, Germany
  • Local Institution
    Hannover, Germany
  • Local Institution
    Leipzig, Germany
  • Local Institution
    Muenchen, Germany
  • Local Institution
    Muenster, Germany
  • Local Institution
    Ratingen, Germany
  • Local Institution
    Cork, Ireland
  • Local Institution
    Dublin, Ireland
  • Local Institution
    Amsterdam, Netherlands
  • Local Institution
    Leiden, Netherlands
  • Local Institution
    Nijmegen, Netherlands
  • Local Institution
    Bern, Switzerland
  • Local Institution
    Birmingham, United Kingdom
  • Local Institution
    Cambridge, United Kingdom
  • Local Institution
    Leeds, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00279760
Lead sponsor
Bristol-Myers Squibb
First posted
Jan 20, 2006
Primary completion
Mar 2002
Last update
Sep 16, 2016

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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