Systemic Juvenile Idiopathic Arthritis
Conditions
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion pf patients who achieved a minimum adapted ACR Pediatric 30 criteria [ Time Frame: Week 8 ] [ Designated as safety issue: No ] To evaluate the efficacy of canakinumab, defined as the proportion of patients who achieved a minimum adapted ACR Pediatric 30 criteria at Week 8 Proportion of patients with canakinumab treatment who were able to taper corticosteroids successfully [ Time Frame: Week 28 ] [ Designated as safety issue: No ] To evaluate the proportion of patients with canakinumab treatment who were able to taper corticosteroids successfully at Week 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who met the adapted ACR Pediatric 30/50/70/90/100 criteria of canakinumab over time [ Designated as safety issue: No ] To evaluate the efficacy (proportion of patients who met the adapted ACR Pediatric 30/50/70/90/100 criteria) of canakinumab over time Change from baseline in components of the adapted ACR pediatric criteria of canakinumab over time [ Designated as safety issue: No ] Change/percent change from baseline will be provided by visit. ACR components: Physician's Global Assessment of disease activity, Parent's or patient's Global Assessment of Subject's overall well-being, Functional ability of CHAQ, Number of joints with active arthritis using the ACR definition, Number of joints with limitation of motion, Standardized CRP. Number of patients having fever will be described by visit. Proportion of patients who had flares with canakinumab treatment over time [ Designated as safety issue: No ] To evaluate the proportion of patients who had flares with canakinumab treatment over time | — |
Outcome results
None listed