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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Belatacept (Drug); Abatacept (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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

Secondary outcome: 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

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

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, 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

Local Institution, Birmingham, Alabama, United States

Local Institution, Huntsville, Alabama, United States

Local Institution, Edmonton, Alberta, Canada

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, St. John's, Newfoundland and Labrador, Canada

Local Institution, Chapel Hill, North Carolina, United States

Local Institution, Cincinnati, Ohio, United States

Local Institution, Cleveland, Ohio, United States

Local Institution, Calgary, Ontario, Canada

Local Institution, Ottawa, Ontario, Canada

Local Institution, Toronto, Ontario, Canada

Local Institution, Portland, Oregon, United States

Local Institution, Montreal, Quebec, Canada

Local Institution, Sherbrook, Quebec, Canada

Local Institution, Ste-Foy, Quebec, Canada

Local Institution, Saskatoon, Saskatchewan, Canada

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

Additional Information

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm


Last updated: April 29, 2010

Page last updated: August 23, 2015

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