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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.
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| Measure | Description | Time Frame |
|---|---|---|
| To monitor and further explore the overall safey of canakinumab focusing in serious infections | At least 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with CAPS and treated with canakinumab. Patients treated with canakinumab for other autoinflammatory diseases may be included where allowed per local regulations.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock Allergy and Asthma Clinic | Little Rock | Arizona | 72205 | United States | ||
| Allergy Center at Brookstone |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34001647 | Derived | Walker UA, Tilson HH, Hawkins PN, Poll TV, Noviello S, Levy J, Vritzali E, Hoffman HM, Kuemmerle-Deschner JB; CACZ885D2401 Study Investigators. Long-term safety and effectiveness of canakinumab therapy in patients with cryopyrin-associated periodic syndrome: results from the beta-Confident Registry. RMD Open. 2021 May;7(2):e001663. doi: 10.1136/rmdopen-2021-001663. |
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| at least 5 years |
| 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 malignancies | at least 5 years |
| Incidence of hypersensitivity reactions | at least 5 years |
| Columbus |
| Georgia |
| 31904 |
| United States |
| Rush Presbyterian - St. Lukes Medical Center | Chicago | Illinois | 60612 | United States |
| 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 | Tübingen | Germany |
| Novartis Investigative site | Oslo | Norway |
| Novartis Investigative site | Aarau | Switzerland |
| Novartis Investigative site | Basel | Switzerland |
| Novartis Investigative site | Geneva | Switzerland |
| Novartis Investigative site | Lausanne | Switzerland |
| ID | Term |
|---|---|
| D056587 | Cryopyrin-Associated Periodic Syndromes |
| ID | Term |
|---|---|
| D056660 | Hereditary Autoinflammatory Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000094482 | Chronic Inducible Urticaria |
| D000080223 | Chronic Urticaria |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D000096703 | Cold Urticaria |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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