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

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ClinicalTrials.gov Identifier: NCT01213641

Recruitment Status : Completed

First Posted : October 4, 2010

Last Update Posted : March 28, 2016

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

Study Description

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.

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

Study Design

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Study Type :	Observational
Actual Enrollment :	288 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	An Open-label, Long-term, Prospective, Observational Study to Monitor the Safety and Effectiveness of Ilaris in CAPS Patients
Study Start Date :	November 2009
Actual Primary Completion Date :	December 2015
Actual Study Completion Date :	December 2015

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Neonatal onset multisystem inflammatory disease

Genetic and Rare Diseases Information Center resources: Cryopyrin-associated Periodic Syndrome Familial Cold Autoinflammatory Syndrome Wells Syndrome Muckle-Wells Syndrome Neonatal Onset Multisystem Inflammatory Disease Familial Mediterranean Fever

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome 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 [ Time Frame: at least 5 years ]

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients diagnosed with CAPS and treated with canakinumab. Patients treated with canakinumab for other autoinflammatory diseases may be included where allowed per local regulations.

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01213641

Locations

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United States, Arizona
Little Rock Allergy and Asthma Clinic
Little Rock, Arizona, United States, 72205
United States, Georgia
Allergy Center at Brookstone
Columbus, Georgia, United States, 31904
United States, Illinois
Rush Presbyterian - St. Lukes Medical Center
Chicago, Illinois, United States, 60612
Austria
Novartis Investigative site
Bregenz, Austria
Novartis Investigative site
Vienna, Austria
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, Germany
Norway
Novartis Investigative site
Oslo, Norway
Switzerland
Novartis Investigative site
Aarau, Switzerland
Novartis Investigative site
Basel, Switzerland
Novartis Investigative site
Geneve, Switzerland
Novartis Investigative site
Lausanne, Switzerland

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

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Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

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Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01213641 History of Changes
Other Study ID Numbers:	CACZ885D2401
First Posted:	October 4, 2010 Key Record Dates
Last Update Posted:	March 28, 2016
Last Verified:	March 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):


Cryopyrin-associated periodic syndromes(CAPS) CIAS1 protein NLRP3 protein human cryopyrin protein Familial Cold Autoinflammatory Syndrome(FCAS)	Muckle-Wells Syndrome(MWS) Neonatal Onset Multisystem Inflammatory disease(NOMID) NALP3 canakinumab Interleukin-1(IL-1)

Additional relevant MeSH terms:

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Cryopyrin-Associated Periodic Syndromes Syndrome Disease Pathologic Processes	Hereditary Autoinflammatory Diseases Genetic Diseases, Inborn Skin Diseases, Genetic Skin Diseases

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