A Phase 2b to investigate the effectiveness of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.

• 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: EUCTR2011-005634-19-EE
• Lead Sponsor: MedImmune Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-16
• Last Update Posted: 14 April 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

A diagnosis of adult onset 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 DMARDs
No evidence of respiratory disease
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 252
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

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
Subjects with chronic active hepatitis B as defined in 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 evaluate the efficacy of mavrilimumab in subjects with moderate-to-severe adult onset RA.;Secondary Objective: To evaluate the safety, tolerability, PK, IM and other clinical outcomes in RA.;Primary end point(s): Change from Day 1 score at Week 12 (assessment 1) and Week 24 (assessment 2) in protocol-defined assessments of RA efficacy.;Timepoint(s) of evaluation of this end point: Week 12 and Week 24.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To evaluate the safety, tolerability, PK, IM and other clinical outcomes in RA.;Timepoint(s) of evaluation of this end point: As specified by the protocol (Table 5.1-1)