Study to Characterize the Pharmacokinetics of a Single Dose of SC Abatacept 125 mg Using the BD Autoinjector or the Prefilled Syringe



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2013
End Date:November 2014

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Phase Ib, Multicenter, Randomized, Open-Label, Parallel-Group Study to Characterize the Pharmacokinetics of a Single Dose of Abatacept 125 mg Administered Subcutaneously Using the BD Physioject™ Autoinjector or the UltraSafe Passive Needle Guard Prefilled Syringe

The primary purpose of the protocol is to describe the pharmacokinetics of a single dose of
Abatacept 125 mg in Rheumatoid Arthritis patients delivered via the autoinjector device or
the approved prefilled syringe.

SC=Subcutaneous

Key Inclusion Criteria:

- Subjects ≥18 years of age

- Diagnosis of Rheumatoid Arthritis confirmed by participant's physician

- Disease activity under control

Key Exclusion Criteria:

- Change in disease-modifying antirheumatic drug (DMARD) therapy within 3 months of
enrollment

- 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
We found this trial at
14
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Huntsville, AL
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4460 Red Bank Expressway
Cincinnati, Ohio 45227
513-721-3868
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Cincinnati, OH
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Wichita, KS
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Centennial, Colorado 80112
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Centennial, CO
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Charlotte, North Carolina 28210
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Charlotte, NC
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Dallas, TX
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Daytona Beach, Florida 32117
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Daytona Beach, FL
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Duncansville, Pennsylvania 16635
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Duncansville, PA
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Lincoln, Nebraska 68512
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Lincoln, NE
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Raleigh, NC
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Salisbury, North Carolina 28144
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Salisbury, NC
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San Fernando, Buenos Aires
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San Fernando,
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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Wilmington, NC
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Worcester, Massachusetts 01610
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Worcester, MA
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