A Study of Anakinra in Japanese Patients With Still's Disease (SJIA and AOSD) (NCT05814159) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study of Anakinra in Japanese Patients With Still's Disease (SJIA and AOSD)
Japan15 participantsStarted 2022-08-24
Plain-language summary
A study to demonstrate efficacy and safety of anakinra in pediatric and adult Japanese patients with Still's disease (Systemic juvenile idiopathic arthritis \[SJIA\] and Adult-onset Still's disease \[AOSD\]).
Who can participate
Age range8 Months
SexALL
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Inclusion criteria
✓. Male and female patients, 8 months of age or older with a body weight ≥ 10 kg
✓. Diagnosis of Still's disease
✓. If \< 16 years of age at disease onset, the diagnosis is madeaccording to adapted ILAR criteria i.e., CARRA criteria for SJIA. If ≥ 16 years of age at disease onset, the diagnosis is made according to Yamaguchi criteria for AOSD.
✓. Active disease confirmed by the following three signs and symptoms. a. Active arthritis in ≥ 1 joint. b. CRP \> 30 mg/L. c. At least one fever episode (≥ 38.0 degree Celsius) attributable to the disease within one week before enrollment.
✓. The result of tuberculosis test within 8 weeks prior to enrollment is negative.
Exclusion criteria
✕. Previous or current treatment with anakinra, or any other Interleukin-1 (IL-1) inhibitor except for canakinumab. Previous treatment with canakinumab is allowed if canakinumab was discontinued for reasons other than lack of efficacy and after a washout period of minimum 130 days. Patients who have discontinued canakinumab because of insufficient effect or refractory disease are not allowed to be enrolled in the study.
✕. Use of the following therapies prior to enrollment.
✕. Narcotic analgesics within 24 hours prior to enrollment.
✕. Diaminodiphenyl sulfone within 1 week prior to enrollment or etanercept within 2 weeks prior to enrollment.
✕. Intraarticular, intramuscular, or intravenous administration of glucocorticoids within 72h(3 days) prior to enrollment, or intravenous immunoglobulin within 4 weeks prior to enrollment.
What they're measuring
1
An improvement of ≥ 30% from baseline in physician global assessment of disease activity (visual analogue scale [VAS]).
Timeframe: Week 2
2
An improvement of ≥ 30% from baseline in patient/parent global assessment of overall well-being (VAS).
Timeframe: Week 2
3
An improvement of ≥ 30% from baseline in number of joints with active arthritis.
Timeframe: Week 2
4
An improvement of ≥ 30% from baseline in number of joints with limitation of motion.
Timeframe: Week 2
5
An improvement of ≥ 30% from baseline in assessment of physical function: Child health assessment questionnaire (CHAQ)/Stanford health assessment questionnaire (SHAQ).
Timeframe: Week 2
6
An improvement of ≥ 30% from baseline in C-reactive protein (CRP) (mg/L).
✕. Intravenous immunoglobulins with proven Still's disease modifying effect, leflunomide, infliximab, or adalimumab within 8 weeks prior to enrollment.
✕. Thalidomide within 72h(3 days) prior to enrollment, cyclosporine within 5 weeks prior to enrollment, mycophenolate mofetil within 1 week prior to enrollment, 6-mercaptopurine within 48h(2 days) prior to enrollment, azathioprine within 72h(3 days) prior to enrollment, cyclophosphamide within 96h(4 days) prior to enrollment, chlorambucil (not approved inJapan) within 48h(2 days) prior to enrollment, or any other immunosuppressants within 12 weeks prior to enrollment.
✕. Tocilizumab within 4 weeks prior to enrollment or any other immunomodulatory medications within 4 half-lives prior to enrollment.