A Study of Anakinra in Japanese Patients With Still's Disease (SJIA and AOSD)
- Conditions
- Still's Disease, Juvenile OnsetStill's Disease, Adult-Onset
- Registration Number
- NCT05814159
- Lead Sponsor
- Swedish Orphan Biovitrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria:<br><br> 1. Male and female patients, 8 months of age or older with a body weight = 10 kg<br><br> 2. Diagnosis of Still's disease<br><br> 3. If < 16 years of age at disease onset, the diagnosis is madeaccording to adapted<br> ILAR criteria i.e., CARRA criteria for SJIA. If = 16 years of age at disease onset,<br> the diagnosis is made according to Yamaguchi criteria for AOSD.<br><br> 4. Active disease confirmed by the following three signs and symptoms. a. Active<br> arthritis in = 1 joint. b. CRP > 30 mg/L. c. At least one fever episode (= 38.0<br> degree Celsius) attributable to the disease within one week before enrollment.<br><br> 5. The result of tuberculosis test within 8 weeks prior to enrollment is negative.<br><br>Exclusion Criteria:<br><br> 1. Previous or current treatment with anakinra, or any other Interleukin-1 (IL-1)<br> inhibitor except for canakinumab. Previous treatment with canakinumab is allowed if<br> canakinumab was discontinued for reasons other than lack of efficacy and after a<br> washout period of minimum 130 days. Patients who have discontinued canakinumab<br> because of insufficient effect or refractory disease are not allowed to be enrolled<br> in the study.<br><br> 2. Use of the following therapies prior to enrollment.<br><br> 1. Narcotic analgesics within 24 hours prior to enrollment.<br><br> 2. Diaminodiphenyl sulfone within 1 week prior to enrollment or etanercept within<br> 2 weeks prior to enrollment.<br><br> 3. Intraarticular, intramuscular, or intravenous administration of glucocorticoids<br> within 72h(3 days) prior to enrollment, or intravenous immunoglobulin within 4<br> weeks prior to enrollment.<br><br> 4. Intravenous immunoglobulins with proven Still's disease modifying effect,<br> leflunomide, infliximab, or adalimumab within 8 weeks prior to enrollment.<br><br> 5. Thalidomide within 72h(3 days) prior to enrollment, cyclosporine within 5 weeks<br> prior to enrollment, mycophenolate mofetil within 1 week prior to enrollment,<br> 6-mercaptopurine within 48h(2 days) prior to enrollment, azathioprine within<br> 72h(3 days) prior to enrollment, cyclophosphamide within 96h(4 days) prior to<br> enrollment, chlorambucil (not approved inJapan) within 48h(2 days) prior to<br> enrollment, or any other immunosuppressants within 12 weeks prior to<br> enrollment.<br><br> 6. Tocilizumab within 4 weeks prior to enrollment or any other immunomodulatory<br> medications within 4 half-lives prior to enrollment.<br><br> 7. Rituximab within 13 weeks prior to enrollment.<br><br> 8. Canakinumab within 130 days prior to enrollment<br><br> 3. Live vaccines within 4 weeks prior to enrollment.<br><br> 4. Known presence or suspicion of active, chronic, or recurrent bacterial, fungal, or<br> viral infections, including but not limited to tuberculosis, HIV infection, Covid-19<br> infection, or hepatitis B or C infection at baseline. Patients with acute or chronic<br> HBV.<br><br> 5. Clinical evidence of liver disease or liver injury as indicated by presence of<br> abnormal liver tests.<br><br> 6. Presence of severe chronic kidney disease (CKD) grades 4 and 5.<br><br> 7. Presence of neutropenia (absolute neutrophil count [ANC] < 1.5 x 10^9/L).<br><br> 8. Presence of thrombocytopenia (platelets count < 100 x 10^9/L).<br><br> 9. Presence or suspicion of MAS at baseline.<br><br> 10. History or diagnosis of MAS within the last 4 weeks prior to enrollment.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method An improvement of = 30% from baseline in physician global assessment of disease activity (visual analogue scale [VAS]).;An improvement of = 30% from baseline in patient/parent global assessment of overall well-being (VAS).;An improvement of = 30% from baseline in number of joints with active arthritis.;An improvement of = 30% from baseline in number of joints with limitation of motion.;An improvement of = 30% from baseline in assessment of physical function: Child health assessment questionnaire (CHAQ)/Stanford health assessment questionnaire (SHAQ).;An improvement of = 30% from baseline in C-reactive protein (CRP) (mg/L).
- Secondary Outcome Measures
Name Time Method