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

Cryopyrin-associated Periodic Syndromes (CAPS) Clinical Trial

— B-Confident  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01213641
• Other study ID #: CACZ885D2401
• Status: Completed
• Phase: N/A
• First received: September 30, 2010
• Last updated: March 25, 2016
• Start date: November 2009
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: SwissmedicGermany: Paul-Ehrlich-InstitutGermany: BfArM
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Austria	Novartis Investigative site	Bregenz
Austria	Novartis Investigative site	Vienna
Germany	Novartis Investigative site	Dresden
Germany	Novartis Investigative site	Hamburg
Germany	Novartis Investigative site	Heidelberg
Germany	Novartis Investigative site	Herne
Germany	Novartis Investigative site	Kiel
Germany	Novartis Investigative site	Schweinfurt
Germany	Novartis Investigative site	Tuebingen
Norway	Novartis Investigative site	Oslo
Switzerland	Novartis Investigative site	Aarau
Switzerland	Novartis Investigative site	Basel
Switzerland	Novartis Investigative site	Geneve
Switzerland	Novartis Investigative site	Lausanne
United States	Rush Presbyterian - St. Lukes Medical Center	Chicago	Illinois
United States	Allergy Center at Brookstone	Columbus	Georgia
United States	Little Rock Allergy and Asthma Clinic	Little Rock	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Austria,  Germany,  Norway,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To monitor and further explore the overall safey of canakinumab focusing in serious infections		At least 5 years	Yes
Secondary	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	No
Secondary	Growth and development patterns of children aged 4 to 18 years of age exposed to Ilaris		at least 5 years	No
Secondary	Identify previously unrecognized serious adverse drug reactions in the treated population		at least 5 years	No
Secondary	Usage and patterns of dosing of Ilaris in routine clinical practice		at least 5 years	No
Secondary	Incidence of serious infections		at least 5 years	No
Secondary	Incidence of malignancies		at least 5 years	No
Secondary	Incidence of hypersensitivity reactions		at least 5 years	No