NCT01706926

A Study of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis

A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of 3 subcutaneous doses of mavrilimumab compared with placebo in combination with methotrexate (MTX) in subjects with moderate-to-severe adult onset Rheumatoid Arthritis (RA).

Detailed description

Despite the therapeutic improvements with recent biologic agents approved for rheumatoid arthritis, there is still 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. The aim of the study is to explore the optimum dose of mavrilimumab for further clinical development and more fully investigate the efficacy and safety profile of mavrilimumab after longer drug exposure (that is, 24 weeks). The results of this study will form the basis for future clinical studies with mavrilimumab.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	Mavrilimumab 30 mg	Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks
BIOLOGICAL	Mavrilimumab 100 mg	Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks.
BIOLOGICAL	Mavrilimumab 150 mg	Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks.
OTHER	Placebo	Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks.

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-12-01
• Completion: 2014-01-01
• First posted: 2012-10-15
• Last updated: 2016-09-27
• Results posted: 2016-09-27

Locations

42 sites across 14 countries: Argentina, Bulgaria, Chile, Colombia, Czechia, Estonia, Germany, Hungary, Poland, Russia, Serbia, South Africa, Spain, Ukraine