Study to Characterize the Pharmacokinetics of a Single Dose of SC Abatacept 125 mg Using the BD Autoinjector or the Prefilled Syringe

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: Abatacept

Study type: Interventional

Funder types: Industry

Identifiers

NCT01890473

IM101-366

Details and patient eligibility

About

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 prefilled syringe.

Full description

SC=Subcutaneous

Enrollment: 356 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Subjects ≥18 years of age
• Diagnosis of Rheumatoid Arthritis confirmed by participant's physician
• Disease activity under control

Key Exclusion Criteria:

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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356 participants in 2 patient groups

Arm 1: Abatacept (autoinjector)

Experimental group

Description:

Abatacept 125 mg/syringe subcutaneously through autoinjector, one dose in 71 days

Treatment:

Drug: Abatacept

Arm 2: Abatacept (prefilled syringe)

Experimental group

Description:

Abatacept 125 mg/syringe subcutaneously with prefilled syringe, one dose in 71 days

Treatment:

Drug: Abatacept