Abatacept Versus Adalimumab Head-to-Head

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Abatacept; Drug: Adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00929864

IM101-235

Details and patient eligibility

About

The purpose of this study is demonstrate that subcutaneous abatacept is non-inferior (no worse than) to subcutaneous adalimumab in the treatment of subjects with rheumatoid arthritis who are biologic naive

Enrollment: 869 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe Rheumatoid arthritis (RA) according to American College of Rheumatology (ACR) criteria
• Methotrexate failure
• Naive to RA biologics
• ≤5 years duration of disease
• Disease Activity Score-28 C-reactive protein (DAS28 CRP) ≥ 3.2
• Willingness to self-inject subcutaneous (SC) drug

Exclusion criteria

• Previous or current medical conditions that are warnings against the use of tumor necrosis factor (TNF)-blocking agents
• History of active or chronic hepatitis
• Cancer in the last 5 years
• History of severe chronic or recurrent bacterial or viral infections
• Risk of tuberculosis
• Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, Gastro-intestinal, pulmonary, cardiac, neurologic, or cerebral disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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869 participants in 2 patient groups

Abatacept

Active Comparator group

Treatment:

Drug: Abatacept

Adalimumab

Active Comparator group

Treatment:

Drug: Adalimumab