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

Novartis Pharmaceuticals4 sites in 2 countries288 target enrollmentNovember 2009

ConditionsCryopyrin-associated Periodic Syndromes (CAPS)Familial Cold Autoinflam Syn (FCAS)Muckle-wells Syn (MWS)Neonatal Onset Multisystem Inflam Disease (NOMID)

Overview

Phase: N/A
Intervention: Not specified
Conditions: Cryopyrin-associated Periodic Syndromes (CAPS)
Sponsor: Novartis Pharmaceuticals
Enrollment: 288
Locations: 4
Primary Endpoint: To monitor and further explore the overall safey of canakinumab focusing in serious infections
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

December 2015

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

To monitor and further explore the overall safey of canakinumab focusing in serious infections

Time Frame: At least 5 years

Secondary Outcomes

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