drugset
drugset / Trial / NCT03265132

A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Still's Disease (SJIA and AOSD)

NCT03265132 ↗

Phase 3 Terminated 13 enrolled Swedish Orphan Biovitrum
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The aim of this study is to demonstrate the efficacy and to evaluate the safety, pharmacokinetics (PK) and immunogenicity of anakinra in patients with newly diagnosed Still's disease, including SJIA (Systemic juvenile idiopathic arthritis) and AOSD (Adult-onset Still's disease).

Timeline

Start
2017-09-26
Primary completion
2019-02-13
Completion
2019-05-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Anakinra Protein / enzyme biologic 2 mg/kg Subcutaneous
Subject Anakinra Protein / enzyme biologic 4 mg/kg Subcutaneous

Indications

adult-onset Still disease systemic-onset juvenile idiopathic arthritis