Canakinumab use in Schnitzler’s syndrome in real-world patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects data on patients with Schnitzler’s syndrome who are being treated with canakinumab in real-world clinical settings. It aims to document effectiveness and safety of the drug outside a controlled trial. Inclusion focuses on patients diagnosed with Schnitzler’s syndrome who start canakinumab or are already receiving it, excluding those previously treated in a specific prior study or for other indications. The study is sponsored by Novartis with investigative sites in Kobe, Ushiku, and Kanoya to capture post-marketing surveillance information.

Why it matters

Who can join: the full rules

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

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).

Where it's running

• Novartis Investigative Site
  Kobe, Hyōgo, Japan Recruiting
• Novartis Investigative Site
  Ushiku, Ibaraki, Japan Recruiting
• Novartis Investigative Site
  Kanoya, Kagoshima-ken, Japan Recruiting
• Novartis Investigative Site
  Yokohama, Kanagawa, Japan Recruiting
• Novartis Investigative Site
  Osaka, Japan Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.