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

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00279760

Purpose

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 I Phase II

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Abatacept Cytotoxic T-lymphocyte antigen 4

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279760

Show 60 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

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

Study ID Numbers:	IM103-002
Study First Received:	January 18, 2006
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00279760
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Abatacept
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Cytotoxic T-lymphocyte antigen 4

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009