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

- To monitor and further explore the overall safey of canakinumab focusing in serious infections [ Time Frame: 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) [ 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 ]

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

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
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 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
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:
Syndrome Cryopyrin-Associated Periodic Syndromes Disease Pathologic Processes |
Hereditary Autoinflammatory Diseases Genetic Diseases, Inborn Skin Diseases, Genetic Skin Diseases |