Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA
- Conditions
- Systemic Juvenile Idiopathic Arthritis
- Registration Number
- JPRN-jRCT2080222813
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Confirmed diagnosis of SJIA as per ILAR definition (Petty, et al. 2004) that must have occurred at least 3 months prior to enrollment with an onset of disease less than 16 years of age: Arthritis in one or more joints, with or preceded by fever of at least 2 weeks duration that is documented to be daily/quotidian for at least 3 days and accompanied by one or more of the following: Rash due to SJIA,lymphadenopathy, Hepatomegaly/Splenomegaly, Serositis
- Active disease at the time of baseline defined as follows:
-At least 2 joints with active arthritis
-Documented spiking, intermittent fever (body temperature more than 38 degrees Celsius) for at least 1 day during the screening epoch and within 1 week before first canakinumab dose
-CRP more than 30 mg/L(3 mg/dL) (normal range less than 10 mg/L(1 mg/dL))
-Negative TB screen (Chest X-ray and T-SPOT test)
Exclusion Criteria:
-With active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection. Patients with resolved/previous hepatitis B infection (a negative HBs antigen, but a positive anti-HBs antibody and/or anti-HBc antibody).
-With underlying metabolic, renal, hepatic, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and /or places the patient at unacceptable risk for participation.
-With neutropenia (absolute neutrophil count less than 1500/mm3) at screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion pf patients who achieved a minimum adapted ACR Pediatric 30 criteria [ Time Frame: Week 8 ] [ Designated as safety issue: No ]<br>To evaluate the efficacy of canakinumab, defined as the proportion of patients who achieved a minimum adapted ACR Pediatric 30 criteria at Week 8<br>Proportion of patients with canakinumab treatment who were able to taper corticosteroids successfully [ Time Frame: Week 28 ] [ Designated as safety issue: No ]<br>To evaluate the proportion of patients with canakinumab treatment who were able to taper corticosteroids successfully at Week 28
- Secondary Outcome Measures
Name Time Method