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

MedImmune

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Other: Placebo; Biological: Mavrilimumab 30 mg; Biological: Mavrilimumab 100 mg; Biological: Mavrilimumab 150 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01706926

CD-IA-CAM-3001-1071

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 420 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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420 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram \[mg\] per week) through oral or parenteral route.

Treatment:

Other: Placebo

Mavrilimumab 30 mg

Experimental group

Description:

Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Treatment:

Biological: Mavrilimumab 30 mg

Mavrilimumab 100 mg

Experimental group

Description:

Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Treatment:

Biological: Mavrilimumab 100 mg

Mavrilimumab 150 mg

Experimental group

Description:

Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Treatment:

Biological: Mavrilimumab 150 mg