Brief Summary

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Official Title: "An Open-label, Long-term, Prospective, Observational Study to Monitor the Safety and Effectiveness of Ilaris in CAPS Patients"

The purpose of this observational study is to collect additional information regarding long-term safety and effectiveness of Ilaris in the treatment of CAPS patients in clinical practice.

• Study Type: Observational
• Study Design: Observational Model: Cohort, Time Perspective: Prospective
• Study Primary Completion Date: December 2014

Outcome Measures for this Clinical Trial

Primary Measures

• To monitor and further explore the overall safey of canakinumab focusing in serious infections
  • Time Frame: At least 5 years
    

Secondary Measures

• Long-term impact of Ilaris on disease progression (including systemic AA amyloidosis as evidenced by renal function, neurologic and ophthalmologic symptoms, and sensorineural deafness)
  • Time Frame: At least 5 years
    
• Growth and development patterns of children aged 4 to 18 years of age exposed to Ilaris
  • Time Frame: at least 5 years
    
• Identify previously unrecognized serious adverse drug reactions in the treated population
  • Time Frame: at least 5 years
    
• Usage and patterns of dosing of Ilaris in routine clinical practice
  • Time Frame: at least 5 years
    
• Incidence of serious infections
  • Time Frame: at least 5 years
    
• Incidence of malignancies
  • Time Frame: at least 5 years
    
• Incidence of hypersensitivity reactions

Criteria for Participation in this Clinical Trial

Inclusion Criteria

• Patients receiving Ilaris (canakinumab) at the time of enrollment as part of medical care

Exclusion Criteria

• Local regulations in some locations may exclude patients who receive Ilaris for a non-approved indication
• Other protocol-defined inclusion/exclusion criteria may apply

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • Novartis Pharmaceuticals
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals
• Overall Contact(s)
  • Novartis Pharmaceuticals, +41-61-324-1111