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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 26 September 2016
Main ID:  NCT00279760
Date of registration: 18/01/2006
Prospective Registration: No
Primary sponsor: Bristol-Myers Squibb
Public title: Phase I/II Multiple-Dose LEA29Y vs CTLAG4Ig vs Placebo in Rheumatoid Arthritis
Scientific 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
Date of first enrolment: January 2000
Target sample size: 210
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00279760
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment  
Phase:  Phase 1/Phase 2
Countries of recruitment
Belgium Canada France Germany Ireland Netherlands Switzerland United Kingdom
United States
Contacts
Name:     Bristol-Myers Squibb
Address: 
Telephone:
Email:
Affiliation:  Bristol-Myers Squibb
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Abatacept
Drug: Belatacept
Primary Outcome(s)
Assess the relative safety and preliminary efficacy (clinical activity) of BMS-188667 and BMS-224818 in subjects with rheumatoid arthritis (RA)
Secondary Outcome(s)
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
Secondary ID(s)
IM103-002
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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