Clinical trial NCT00279760: Phase I/II Multiple-Dose LEA29Y vs CTLAG4Ig vs Placebo in Rheumatoid Arthritis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-01-20
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility 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

Primary outcomes:
measure: Assess the relative safety and preliminary efficacy (clinical activity) of BMS-188667 and BMS-224818 in subjects with rheumatoid arthritis (RA)
Secondary outcomes:
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
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution
state: Alabama
city: Huntsville
country: United States
facility: Local Institution
state: Alabama
city: Phoenix
country: United States
facility: Local Institution
state: Arizona
city: Tucson
country: United States
facility: Local Institution
state: Arizona
city: Los Angeles
country: United States
facility: Local Institution
state: California
city: San Diego
country: United States
facility: Local Institution
state: California
city: Miami
country: United States
facility: Local Institution
state: Florida
city: Chicago
country: United States
facility: Local Institution
state: Illinois
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
city: Duluth
country: United States
facility: Local Institution
state: Minnesota
city: New Brunswick
country: United States
facility: Local Institution
state: New Jersey
city: New York
country: United States
facility: Local Institution
state: New York
city: Chapel Hill
country: United States
facility: Local Institution
state: North Carolina
city: Cincinnati
country: United States
facility: Local Institution
state: Ohio
city: Cleveland
country: United States
facility: Local Institution
state: Ohio
city: Portland
country: United States
facility: Local Institution
state: Oregon
city: Nashville
country: United States
facility: Local Institution
state: Tennessee
city: Dallas
country: United States
facility: Local Institution
state: Texas
city: Salt Lake City
country: United States
facility: Local Institution
state: Utah
city: Seattle
country: United States
facility: Local Institution
state: Washington
city: Bruxelles
country: Belgium
facility: Local Instiution
city: Diepenbeek
country: Belgium
facility: Local Institution
city: Gent
country: Belgium
facility: Local Institution
city: Liege 1
country: Belgium
facility: Local Institution
city: Mons
country: Belgium
facility: Local Institution
city: Pellenberg
country: Belgium
facility: Local Institution
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: St. John's
country: Canada
facility: Local Institution
state: Newfoundland and Labrador
city: Calgary
country: Canada
facility: Local Institution
state: Ontario
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Sherbrook
country: Canada
facility: Local Institution
state: Quebec
city: Ste-Foy
country: Canada
facility: Local Institution
state: Quebec
city: Saskatoon
country: Canada
facility: Local Institution
state: Saskatchewan
city: Lille
country: France
facility: Local Institution
city: Lyon
country: France
facility: Local Institution
city: Montpellier
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Rennes
country: France
facility: Local Institution
city: Strasbourg
country: France
facility: Local Institution
city: Toulouse
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Duesseldorf
country: Germany
facility: Local Institution
city: Erlangen
country: Germany
facility: Local Institution
city: Fankfurt
country: Germany
facility: Local Institution
city: Hannover
country: Germany
facility: Local Institution
city: Leipzig
country: Germany
facility: Local Institution
city: Muenchen
country: Germany
facility: Local Institution
city: Muenster
country: Germany
facility: Local Institution
city: Ratingen
country: Germany
facility: Local Institution
city: Cork
country: Ireland
facility: Local Institution
city: Dublin
country: Ireland
facility: Local Institution
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Leiden
country: Netherlands
facility: Local Institution
city: Nijmegen
country: Netherlands
facility: Local Institution
city: Bern
country: Switzerland
facility: Local Institution
city: Birmingham
country: United Kingdom
facility: Local Institution
city: Cambridge
country: United Kingdom
facility: Local Institution
city: Leeds
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: