Study to Characterize the Pharmacokinetics of a Single Dose of SC Abatacept 125 mg Using the BD Autoinjector or the Prefilled Syringe
NCT ID: NCT01890473
Last Updated: 2015-11-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
356 participants
INTERVENTIONAL
2013-07-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: Abatacept (autoinjector)
Abatacept 125 mg/syringe subcutaneously through autoinjector, one dose in 71 days
Abatacept
Arm 2: Abatacept (prefilled syringe)
Abatacept 125 mg/syringe subcutaneously with prefilled syringe, one dose in 71 days
Abatacept
Interventions
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Abatacept
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Rheumatoid Arthritis confirmed by participant's physician
* Disease activity under control
Exclusion Criteria
* Exposure to investigational drug within 4 weeks or 5 half lives whichever is longer
* Current or prior use of Rituximab ≤6 months
* Current or prior use of the following within 4 weeks or 5 half lives whichever is longer: biologic DMARDS, Tofacitinib, Cyclophosphamide, Mycophenolate Mofetil \& d-Penicillamine
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Rheumatology Associates Of North Alabama, P.C.
Huntsville, Alabama, United States
Immunoe Int'L Research Ctrs
Centennial, Colorado, United States
Covance Cru Inc
Daytona Beach, Florida, United States
Heartland Research Associates, Llc
Wichita, Kansas, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Physician Research Collaboration, Llc
Lincoln, Nebraska, United States
Djl Research, Pllc
Charlotte, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
Pmg Research Of Salisbury
Salisbury, North Carolina, United States
Pmg Research Of Wilmington Llc
Wilmington, North Carolina, United States
Community Research
Cincinnati, Ohio, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Covance Clinical Research Unit Inc.
Dallas, Texas, United States
Local Institution
San Fernando, Buenos Aires, Argentina
Local Institution
Córdoba, Córdoba Province, Argentina
Local Institution
Córdoba, Córdoba Province, Argentina
Local Institution
Rosario, Santa Fe Province, Argentina
Local Institution
San Miguel de Tucumán, Tucumán Province, Argentina
Local Institution
Yucatán, Yucatán, Mexico
Local Institution
Lima, Lima Province, Peru
Local Institution
Lima, Lima Province, Peru
Local Institution
Port Elizabeth, Eastern Cape, South Africa
Local Institution
Pretoria, Gauteng, South Africa
Local Institution
Pretoria, Gauteng, South Africa
Local Institution
George, Western Cape, South Africa
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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IM101-366
Identifier Type: -
Identifier Source: org_study_id