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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01213641
Recruitment Status : Completed
First Posted : October 4, 2010
Last Update Posted : March 28, 2016
Information provided by (Responsible Party):
Novartis ( 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.

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

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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

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

Secondary Outcome Measures :
  1. 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 ]
  2. Growth and development patterns of children aged 4 to 18 years of age exposed to Ilaris [ Time Frame: at least 5 years ]
  3. Identify previously unrecognized serious adverse drug reactions in the treated population [ Time Frame: at least 5 years ]
  4. Usage and patterns of dosing of Ilaris in routine clinical practice [ Time Frame: at least 5 years ]
  5. Incidence of serious infections [ Time Frame: at least 5 years ]
  6. Incidence of malignancies [ Time Frame: at least 5 years ]
  7. Incidence of hypersensitivity reactions [ Time Frame: at least 5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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.

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

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 identifier (NCT number): NCT01213641

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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
Novartis Investigative site
Bregenz, Austria
Novartis Investigative site
Vienna, Austria
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
Novartis Investigative site
Oslo, Norway
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
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01213641    
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)
Additional relevant MeSH terms:
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Cryopyrin-Associated Periodic Syndromes
Pathologic Processes
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases