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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rheumatoid Arthritis

Keywords

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Rheumatoid Arthritis Golimumab Mavrilimumab

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Golimumab 50 mg alternating with Placebo

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.

Group Type EXPERIMENTAL

Golimumab 50 mg

Intervention Type BIOLOGICAL

Participants received alternating doses of golimumab 50 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.

Mavrilimumab 100 mg

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.

Group Type EXPERIMENTAL

Mavrilimumab 100 mg

Intervention Type BIOLOGICAL

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.

Interventions

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Golimumab 50 mg

Participants received alternating doses of golimumab 50 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.

Intervention Type BIOLOGICAL

Mavrilimumab 100 mg

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.

Intervention Type BIOLOGICAL

Other Intervention Names

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CAM-3001

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marius Albulescu

Role: STUDY_DIRECTOR

MedImmune Ltd

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Turkey (Türkiye) Argentina Colombia Czechia France Greece Hungary Israel Mexico Portugal Russia Serbia Slovakia Spain United Kingdom

Other Identifiers

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CD-IA-CAM-3001-1107

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Golimumab 50 mg alternating with Placebo

Golimumab 50 mg

Mavrilimumab 100 mg

Mavrilimumab 100 mg

Interventions

Golimumab 50 mg

Mavrilimumab 100 mg

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

MedImmune LLC

Responsible Party

Principal Investigators

Marius Albulescu

Locations

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Countries

Other Identifiers

CD-IA-CAM-3001-1107