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A randomized, double-blind, placebo-controlled, multicenter, phase 3 efficacy and safety study of 2 dose levels of subcutaneous anakinra (Kineret®) in patients With Still’s disease (SJIA and AOSD)
The aim of this study is to demonstrate the efficacy and to evaluate the safety, pharmacokinetics (PK) and immunogenicity of anakinra in participants with newly diagnosed Still's disease, including SJIA (systemic juvenile idiopathic arthritis) and AOSD (adult-onset Still's disease).
The study consists of a 12-week, randomized, double-blind, placebo-controlled period with two dose levels of anakinra and a 4-week safety follow-up after last dose of investigational medicinal product (IMP). The primary endpoint will be evaluated at week 2. Sustained efficacy and time to study drug discontinuation will be evaluated during the full study period.
A screening visit is optional and may be done to identify participants that could be suitable for the study. During the study 6 visits and 2 telephone contacts are scheduled i.e., day 1 (baseline visit), day 4tel, week 1, week 2, week 4, week 8, week 12 and week 16tel (end of study).
Male and female patients of any age with a body weight ≥ 10 kg (22 lbs.)
For more information, please visit www.clinicaltrials.gov (NCT03265132).
You can also contact the study team at 720-777-2137.