Clinical Trial: Belimumab in Myositis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Belimumab for Maintenance Therapy in Idiopathic Inflammatory Myositis

Brief Summary: The goal of the trial is to evaluate the efficacy and safety of belimumab as a maintenance therapy in adults with refractory Idiopathic inflammatory myositis (IIM) as compared with standard of care. This is a multicentre double-blind, placebo-controlled trial.

Detailed Summary:
Sponsor: Northwell Health

Current Primary Outcome: Response Rate [ Time Frame: 40 weeks ]

percentage of patients meeting definition of improvement (DOI) in both groups


Original Primary Outcome: Same as current

Current Secondary Outcome: Incidence of Flares [ Time Frame: 40 and 64 weeks ]

The flare rates in patients in belimumab arm compared to the flare rates of patients in the placebo arm


Original Secondary Outcome: Same as current

Information By: Northwell Health

Dates:
Date Received: January 22, 2015
Date Started: January 2015
Date Completion:
Last Updated: August 3, 2016
Last Verified: August 2016