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 |
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.
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
sites
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Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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