NCT02347891

Belimumab in Idiopathic Inflammatory Myositis

Belimumab for Maintenance Therapy in Idiopathic Inflammatory Myositis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

Adults with refractory IIM will be enrolled. IIM is defined as Dermatomyositis (DM) or Polymyositis (PM), meeting the Bohan \& Peter (1975) diagnostic criteria for definite or probable DM or PM. Refractory IIM is defined as chronic active IIM with a history of inadequate response or intolerance to three months of glucocorticoids and/or at least a history of inadequate response or intolerance to three months of one other immunosuppressive agent (IS) (azathioprine, methotrexate, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, cyclophosphamide, Rituximab or intravenous gamma globulin \[IVIG\]).

Conditions

• Myositis

Interventions

Type	Name	Description
DRUG	Belimumab	Randomized phase: Week 0 - Week 40
DRUG	Placebo	Randomized phase: Week 0 - Week 40

Timeline

• Start date: 2015-01-01
• Primary completion: 2020-11-01
• Completion: 2020-11-01
• First posted: 2015-01-28
• Last updated: 2024-02-09
• Results posted: 2024-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study