A Study of Mavrilimumab Versus Anti Tumor Necrosis Factor in Subjects With Rheumatoid Arthritis

A Phase 2 Exploratory Study of Mavrilimumab Versus Anti-tumor Necrosis Factor in Subjects With Rheumatoid Arthritis

The primary objectives of this study is to explore the efficacy of mavrilimumab compared with golimumab in the treatment of adult subjects 18-80 years of age with moderate-to-severe active rheumatoid arthritis (RA) who have an inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs) and/or one or two anti-tumor necrosis factor (TNF) agents (excluding golimumab) for efficacy or safety reasons.

Despite the therapeutic improvements with recent biologic agents approved for rheumatoid arthritis (RA), there is still a significant unmet medical need for the treatment of subjects with this chronic disease to achieve a faster, more complete response, and higher rates of remission. The aim of the current study is to compare the efficacy and safety of a subcutaneous dose of mavrilimumab with a marketed treatment for RA (golimumab) in 120 adult subjects with moderate-to-severe active RA who have had an inadequate response to one or two anti-TNF agents with mavrilimumab. The design of the study was exploratory and not formerly statistically powered.

Inclusion Criteria:

• Age 18 through 80 years
• Written consent
• Diagnosis of adult onset Rheumatoid Arthritis (RA) as defined by the 2010 American College of Rheumatology European League Against Rheumatism (ACR/EULAR) classification criteria
• Moderately active disease as defined by disease activity score in 28 joints C-reactive protein (DAS28[CRP]) greater than or equal to (>=) 3.2 at screening and DAS28 erythrocyte sedimentation rate(ESR) ≥ 3.2 at Day 1
• Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs)
• At least 4 swollen joints
• Inadequate response to one or two anti-TNF agents other than the study comparator, as defined by the protocol
• Receiving oral or injectable methotrexate, as defined by the protocol.

Exclusion Criteria:

• A rheumatic autoimmune disease or other inflammatory joint disease other than RA
• Previous treatment with biologic therapies other than anti-TNF for RA
• Treatment with other DMARDs or non-steroidal anti-inflammatory drugs (NSAIDs), as defined by the protocol.
• Medical history as defined by the protocol.