Last updated on August 2018

Belimumab in Idiopathic Inflammatory Myositis

Brief description of study

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 Study 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]).

Clinical Study Identifier: NCT02347891

Contact Investigators or Research Sites near you

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Todd Levine, MD

Phoenix Neurlogical Associates
Phoenix, AZ United States
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Preeya Nandkumar

Northwell Health Divison of Rheumatology
Great Neck, NY United States
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Recruitment Status: Open

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