NCT01712399

A Long Term Safety Study of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis

An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 409 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 19 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. This study is an open-label extension study for subjects who have participated in one of the qualifying development program studies with mavrilimumab. Participation in this study will allow these subjects to continue to receive long-term treatment with mavrilimumab. The data from this study will provide an evaluation of the long-term safety of mavrilimumab in adult subjects with RA. In addition, long-term exploratory efficacy outcomes such as joint damage and disability will be evaluated.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	Mavrilimumab 100 mg	Participants will receive 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years

Timeline

• Start date: 2013-01-28
• Primary completion: 2015-12-30
• Completion: 2015-12-30
• First posted: 2012-10-23
• Last updated: 2017-06-01
• Results posted: 2017-06-01

Locations

52 sites across 19 countries: Argentina, Bulgaria, Chile, Colombia, Czechia, Estonia, Germany, Greece, Hungary, Israel, Mexico, Poland, Russia, Serbia, Slovakia, South Africa, Spain, Ukraine, United Kingdom