Status:
COMPLETED
Study to Characterize the Pharmacokinetics of a Single Dose of SC Abatacept 125 mg Using the BD Autoinjector or the Prefilled Syringe
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 pref...
Detailed Description
SC=Subcutaneous
Eligibility Criteria
Inclusion
- Key
- Subjects ≥18 years of age
- Diagnosis of Rheumatoid Arthritis confirmed by participant's physician
- Disease activity under control
- Key
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
356 Patients enrolled
Trial Details
Trial ID
NCT01890473
Start Date
July 1 2013
End Date
November 1 2014
Last Update
November 26 2015
Active Locations (25)
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1
Rheumatology Associates Of North Alabama, P.C.
Huntsville, Alabama, United States, 35801
2
Immunoe Int'L Research Ctrs
Centennial, Colorado, United States, 80112
3
Covance Cru Inc
Daytona Beach, Florida, United States, 32117
4
Heartland Research Associates, Llc
Wichita, Kansas, United States, 67207