Clinical Outcomes and Safety: A Registry Study of Ilaris (Canakinumab) Patients

Completed

• Conditions: Neonatal Onset Multisystem Inflam Disease (NOMID); Cryopyrin-associated Periodic Syndromes (CAPS); Familial Cold Autoinflam Syn (FCAS); Muckle-wells Syn (MWS)

• Registration Number: NCT01213641
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-09-30
• Study First Submitted QC: 2010-10-01
• Study First Posted: 2010-10-04
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-25
• Last Update Posted: 2016-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 288

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To monitor and further explore the overall safey of canakinumab focusing in serious infections	At least 5 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Novartis Investigative site; 🇨🇭 Lausanne, Switzerland

Little Rock Allergy and Asthma Clinic; 🇺🇸 Little Rock, Arizona, United States

Rush Presbyterian - St. Lukes Medical Center; 🇺🇸 Chicago, Illinois, United States

Allergy Center at Brookstone; 🇺🇸 Columbus, Georgia, United States