A Study of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis

A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis

The primary objective of this study is to evaluate the efficacy of 3 subcutaneous doses of mavrilimumab compared with placebo in combination with methotrexate (MTX) in subjects with moderate-to-severe adult onset Rheumatoid Arthritis (RA).

Despite the therapeutic improvements with recent biologic agents approved for rheumatoid arthritis, there is still 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 study is to explore the optimum dose of mavrilimumab for further clinical development and more fully investigate the efficacy and safety profile of mavrilimumab after longer drug exposure (that is, 24 weeks). The results of this study will form the basis for future clinical studies with mavrilimumab.

Inclusion Criteria:

• A diagnosis of adult onset Rheumatoid Arthritis (RA) in line with the protocol
• Moderately active disease in line with the protocol
• A pre-defined number of swollen joints in line with the protocol
• Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs)
• No evidence of respiratory disease.

Exclusion Criteria:

• A rheumatic autoimmune disease other than RA, or significant systemic extra-articular involvement secondary to RA
• A history of, or current, inflammatory joint disease other than RA
• Previous treatment with the investigational drug
• Discontinuation of a biologic DMARD due to lack of efficacy
• Non-compliant concurrent medications
• Non-compliance with medical history criteria.