Methotrexate-Inadequate Response Autoinjector Device Sub Study

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Abatacept; Methotrexate

Criteria

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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