Phase IIIB Subcutaneous Abatacept Monotherapy Study

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis (RA)

Treatments: Drug: abatacept; Drug: Methotrexate (MTX)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00547521

IM101-173

Details and patient eligibility

About

To evaluate safety and immunogenicity of abatacept when used with or without methotrexate in the absence of an IV loading dose of abatacept

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of Rheumatoid Arthritis
• Subjects Global Disease Assessment of greater than equal to 20 mm on a visual analog scale
• Discontinue all Biologics and Disease-modifying antirheumatic drugs (DMARDS) except for methotrexate

Exclusion criteria

• Received treatment with rituximab
• Subjects who have received treatment with immunoadsorbtion columns (such as Prosorba columns), mycophenolate mofetil (Cellcept®), cyclosporine A or other calcineurin inhibitors, or D-Penicillamine

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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119 participants in 2 patient groups

Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort

Experimental group

Description:

In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.

Treatment:

Drug: Methotrexate (MTX)

Drug: abatacept

SC Abatacept Monotherapy Cohort

Experimental group

Description:

In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.

Treatment:

Drug: abatacept