Rheumatoid Arthritis Clinical Trial
Official title:
Substudy-A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate
The purpose of this study is to implement a substudy in approximately 120 rheumatoid arthritis (RA) subjects to compare the steady-state serum trough concentration (Cminss), Cmax and area under the curve (AUC) during the dosing interval (TAU) of subcutaneous (SC) Abatacept injection of 125 mg via the autoinjector and via the BD Hypak™ Physiolis prefilled syringe.
Study Classification:
- Safety: show if the drug is safe under conditions of proposed use
- Efficacy: measure of an intervention's influence on a disease or health condition
- Safety/Efficacy
- Pharmacokinetics: the action of a drug in the body over a period of time including the
process of absorption, distribution and localization in tissue, biotransformation, and
excretion of the compound.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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