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

MedImmune

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Biological: Golimumab 50 mg; Biological: Mavrilimumab 100 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01715896

CD-IA-CAM-3001-1107

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 215 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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215 participants in 2 patient groups

Golimumab 50 mg alternating with Placebo

Experimental group

Description:

Participants received alternating doses of golimumab 50 milligram (mg) (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections 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: Golimumab 50 mg

Mavrilimumab 100 mg

Experimental group

Description:

Participants received Mavrilimumab 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