A Study of Anakinra in Japanese Patients With Still's Disease (SJIA and AOSD)
← catalyst calendarSponsored by Swedish Orphan Biovitrum (industry) · SOBI.ST — their whole pipeline →. With CMIC Co, Ltd. Japan.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
15actual
Sites
8
Country
Japan
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-08-24 | actual | When the study began enrolling |
| Primary completion | 2025-12-10 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-06-24 | estimated | The whole study's end, after follow-up |
| First posted | 2023-04-14 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-03-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Still's Disease, Juvenile Onset
- Still's Disease, Adult-Onset
Interventions
- Drug: Anakinra — also filed as Kineret
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFAn improvement of ≥ 30% from baseline in physician global assessment of disease activity (visual analogue scale [VAS]).
measured Week 2
An improvement of ≥ 30% from baseline in patient/parent global assessment of overall well-being (VAS).
measured Week 2
An improvement of ≥ 30% from baseline in number of joints with active arthritis.
measured Week 2
An improvement of ≥ 30% from baseline in number of joints with limitation of motion.
measured Week 2
An improvement of ≥ 30% from baseline in assessment of physical function: Child health assessment questionnaire (CHAQ)/Stanford health assessment questionnaire (SHAQ).
measured Week 2
An improvement of ≥ 30% from baseline in C-reactive protein (CRP) (mg/L).
measured Week 2
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