Methotrexate-Inadequate Response Autoinjector Device Sub Study (MTX-IR)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Abatacept

Study type: Interventional

Funder types: Industry

Identifiers

NCT01844895

2007-005434-37 (EudraCT Number)

IM101-174 Substudy-2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

120 participants in 1 patient group

Abatacept (Autoinjector and Prefilled Syringe)

Experimental group

Description:

Abatacept (prefilled syringe) 125 mg/device solution subcutaneously weekly for 3 months Abatacept (autoinjector) 125 mg/device solution subcutaneously weekly for 1 month

Treatment:

Drug: Abatacept