Methotrexate-Inadequate Response Autoinjector Device Sub Study

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.

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Inclusion Criteria:

• Subjects who have been treated in the long term (LT) with open-label SC Abatacept for at least 3 months
• Must continue to meet inclusion criteria specified in main IM101-174 Study Protocol

Exclusion Criteria:

• Participation in previous device substudy (implemented by Amendment 10)
• Must continue to meet exclusion criteria specified in main IM101-174 Study Protocol