drugset / Trial / NCT01165008

Anakinra in Myositis

NCT01165008

Phase 2/3 Completed Karolinska Institutet
NaSingle-groupTreatment

Summary

To investigate the effect of the interleukin-1 (IL-1) blocking agent, anakinra, in patients with treatment-resistant inflammatory myopathies. Patients and methods: Fifteen patients with refractory polymyositis (PM), dermatomyositis (DM), or inclusion body myositis (IBM) were treated with 100 mg anakinra subcutaneously per day during 12 months. Outcome measures included myositis disease activity score with improvement defined according to The International Myositis Assessment and Clinical Studies Group (IMACS) and for muscle performance the functional index of myositis (FI). In addition repeat muscle biopsies were performed

Timeline

Start
2003-09
Primary completion
Completion
2008-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Anakinra Protein / enzyme biologic 100 mg Subcutaneous