A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.

Phase 1

Active, not recruiting

• Conditions: Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]; Rheumatoid arthritis; MedDRA version: 15.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

• Registration Number: EUCTR2011-005648-93-GR
• Lead Sponsor: MedImmune Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-05
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

•Subjects who have completed the treatment period of the qualifying study or will have failed to respond adequately to investigational product at a predefined time point in the qualifying study regardless of their initial randomization.
•No evidence of clinically uncontrolled respiratory disease to be confirmed by a local pulmonologist

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 360
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

•Subjects who have been permanently discontinued from investigational product in previous qualifying study.
•Any new conditions or worsening of any pre-existing conditions 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 long-term safety of mavrilimumab in adult subjects with moderate-to-severe active RA who were previously treated in a qualifying study.;Secondary Objective: Evaluation of clinical effiacy and patient reported outcomes, pharmacodynamic effects and immunogenicity.;Primary end point(s): Long-term safety;Timepoint(s) of evaluation of this end point: At protocol-scheduled evaluation visits, up to 5 years, commercial availability or discontinuation of development, whichever is sooner.