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

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

Outcome

Met primary endpoint

Stopped: “Meeting enrolment target (81 pat) will not be feasible within reasonable time.”

registry analysis (superiority test); Placebo; p = 0.0022; Risk Difference (RD) 1.0 (95% CI 0.42 to 1.00); Fisher Exact NCT03265132 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Anakinra	Protein / enzyme biologic	2 mg/kg	Subcutaneous
Subject	Anakinra	Protein / enzyme biologic	4 mg/kg	Subcutaneous

Indications