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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00279760
• Other study ID #: IM103-002
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 18, 2006
• Last updated: September 15, 2016

Study information

• Verified date: September 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. primary completion date: March 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Belatacept

• Abatacept

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Ireland,  Netherlands,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the relative safety and preliminary efficacy (clinical activity) of BMS-188667 and BMS-224818 in subjects with rheumatoid arthritis (RA)
Secondary	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

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm