An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor.

• Conditions: Rheumatoid arthritis; MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-005649-10-SK
• Lead Sponsor: MedImmune Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-06
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• A diagnosis of at least moderately-active adult onset RA.
• 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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 NSAIDs, as defined by the protocol.
• Medical history as defined by the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To explore the efficacy of mavrilimumab compared to an anti-TNF antibody in adult subjects with moderate-to-severe active RA who have had an inadequate response to one or two other anti-TNF agents for efficacy and safety reasons.;Secondary Objective: Evaluation of safety tolerability, pharmacokinetic effects and immunogenicity of mavrilimumab.;Primary end point(s): Established endpoints of RA efficacy, as defined in the protocol.;Timepoint(s) of evaluation of this end point: Week 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Safety and tolerability via assessment of AEs and SAEs. Assessment of PK and IM parameters, as defined in the protocol.;Timepoint(s) of evaluation of this end point: 36 weeks (24 weeks treatment + 12 weeks Safety Follow-up)