Phase IIIB Subcutaneous Missed Dose Study

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Abatacept; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00533897

IM101-167

Details and patient eligibility

About

The purpose of the study is to determine whether subcutaneous abatacept administered to patients with rheumatoid arthritis is associated with increased immunogenicity or increased safety events upon withdrawal and reintroduction.

Enrollment: 270 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of Rheumatoid Arthritis
• Disease Activity Score (DAS)28-C-Reactive Protein (CRP) score ≥ 3.2 and ≤5.1
• On background methotrexate at least 3 months (≥10mg weekly)
• Must be able to self injection or allow a care giver to do it for them
• Discontinue all Biologics and Disease-Modifying Anti-rheumatic Drugs (DMARDs) except for methotrexate

Exclusion criteria

• Participants who had prior exposure to abatacept or CTLA-4 Ig
• Received treatment with rituximab.
• Participants who have received treatment with leflunomide within 1 year of screening
• Participants who have received treatment with immunoadsorption columns (such as Prosorba columns), mycophenolate mofetil (Cellcept®), cyclosporine A or other calcineurin inhibitors, or D-Penicillamine.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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270 participants in 2 patient groups, including a placebo group

Abatacept

Experimental group

Treatment:

Drug: Abatacept

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo