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) logo

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)

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

Trial contacts and locations

25

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Data sourced from clinicaltrials.gov

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