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.

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

sites

Rheumatology Associates Of North Alabama, P.C.

Huntsville, Alabama 35801

from

Huntsville, AL