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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 September 2016 |
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Main ID: |
NCT00279760 |
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Date of registration:
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18/01/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase I/II Multiple-Dose LEA29Y vs CTLAG4Ig vs Placebo in Rheumatoid Arthritis
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Scientific title:
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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 |
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Date of first enrolment:
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January 2000 |
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Target sample size:
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210 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00279760 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Belgium
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Canada
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France
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Germany
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Ireland
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Netherlands
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Switzerland
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United Kingdom
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United States
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Contacts
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Name:
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Bristol-Myers Squibb |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Belatacept
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Drug: Abatacept
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Primary Outcome(s)
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Assess the relative safety and preliminary efficacy (clinical activity) of BMS-188667 and BMS-224818 in subjects with rheumatoid arthritis (RA)
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Secondary Outcome(s)
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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
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Secondary ID(s)
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IM103-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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