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Recruiting NCT07598422

A Study to Assess the Effectiveness and Safety of Canakinumab in Clinical Use in Patients With Schnitzler's Syndrome

— Observational Schnitzler Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Schnitzler Syndrome. Basic parameters: from 0 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

The aim of this study is to assess the effectiveness and safety of Ilaris (canakinumab) in clinical use in patients with Schnitzler's syndrome.

Primary outcome measures

  • Proportion of Patients Achieving Complete Clinical Response in the Period From 7 Days to 8 Weeks After the First Dose [Time frame: Day 8 to Week 8]
  • Proportion of Patients Achieving Partial or Complete Clinical Response at all Time Points From 7 Days After the First Dose to 48 Weeks After the First Dose [Time frame: Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48]
  • Rate of Each Clinical Response [Time frame: Baseline, Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48]
  • Mean PGA Score [Time frame: Baseline, Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48]
  • Change From Baseline in PGA Score [Time frame: Baseline to Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48]
  • Mean White Blood Cell Count [Time frame: Baseline, Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48]
  • Change From Baseline in White Blood Cell Count [Time frame: Baseline to Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48]
  • Mean Neutrophil Count [Time frame: Baseline, Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48]
  • Change From Baseline in Neutrophil Count [Time frame: Baseline to Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48]
  • Mean C-reactive Protein (CRP) Level [Time frame: Baseline, Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48]
Secondary outcome measures (2)
  • Number and Percentage of Patients With Adverse Reactions [Time frame: From Baseline to Week 48]
  • Number and Percentage of Patients With Serious Adverse Events [Time frame: From Baseline to Week 48]

Eligibility 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

  • Patients previously treated with canakinumab in Study IACT21071.
  • 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.

  • Patients receiving canakinumab for off-label use under the Clinical Trials Act or GCP (e.g., patient-proposed healthcare services, investigator-initiated clinical trial).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Japan · 2 centers
  • Novartis Investigative Site — Kanoya
  • Novartis Investigative Site — Osaka

Identifiers

NCT: NCT07598422 · CACZ885C21401

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗