Specified Use-Results Study of ILARIS Solution for S.C. Injection

Specified Use-Results Study of ILARIS Solution for S.C. Injection (Schnitzler's Syndrome)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT2031260196

Enrollment

Registered

2026-06-04

Start date

2026-05-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schnitzler's Syndrome

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with Schnitzler's syndrome using canakinumab for the first time for the indication of Schnitzler's syndrome as described in the package insert. Patients starting treatment with canakinumab before conclusion of the contract for this study will also be included in the study so that all patients diagnosed with Schnitzler's syndrome who received canakinumab will be registered in this study.

Exclusion criteria

Exclusion criteria: 1.Patients previously treated with canakinumab in Study IACT21071. 2.All patients treated with canakinumab for the following indications: Indications: Cryopyrin-associated periodic syndromes (familial cold autoinflammatory syndrome, Muckle-Wells syndrome, neonatal onset multisystem inflammatory disease), hyper immunoglobulin D (IgD) syndrome (mevalonate kinase deficiency), tumor necrosis factor (TNF) receptor-associated periodic syndrome, familial mediterranean fever, systemic juvenile idiopathic arthritis, adult-onset Still's disease. 3.Patients receiving canakinumab for off-label use under the Clinical Trials Act or GCP (e.g., patient-proposed healthcare services, investigator-initiated clinical trial).

Design outcomes

Primary

Measure	Time frame
Proportion of patients achieving complete clinical response in the period from 7 days to 8 weeks after the first dose Proportion of patients achieving partial clinical response or complete clinical response at all time points from 7 days after the first dose to 48 weeks after the first dose The following endpoints from the start of treatment with Ilaris to the end of the observation period: -Rate of each clinical response at each time point -Mean and change from baseline of PGA score at each time point -Mean and change from baseline of inflammatory markers (white blood cell count, neutrophil count, CRP, and ALP) at each time point -Mean and change from baseline of serum IgG and IgM at each time point -Rate of global assessment of impression of improvement at each time point	—

Measure

Time frame

Proportion of patients achieving complete clinical response in the period from 7 days to 8 weeks after the first dose Proportion of patients achieving partial clinical response or complete clinical response at all time points from 7 days after the first dose to 48 weeks after the first dose The following endpoints from the start of treatment with Ilaris to the end of the observation period: -Rate of each clinical response at each time point -Mean and change from baseline of PGA score at each time point -Mean and change from baseline of inflammatory markers (white blood cell count, neutrophil count, CRP, and ALP) at each time point -Mean and change from baseline of serum IgG and IgM at each time point -Rate of global assessment of impression of improvement at each time point

—

Contacts

Public ContactNovartis Direct

Novartis Pharma. K.K.

sm.pms@novartis.com+81-120003293

Outcome results