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-PL

Lead Sponsor: MedImmune Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

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 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)