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

September 15, 2016 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

210

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Assess the relative safety and preliminary efficacy (clinical activity) of BMS-188667 and BMS-224818 in subjects with rheumatoid arthritis (RA)

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

March 1, 2002

Study Registration Dates

First Submitted

January 18, 2006

First Submitted That Met QC Criteria

January 18, 2006

First Posted (Estimate)

January 20, 2006

Study Record Updates

Last Update Posted (Estimate)

September 16, 2016

Last Update Submitted That Met QC Criteria

September 15, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM103-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Locations

3
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