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This study will assess the safety, tolerability and efficacy of canakinumab treatment in Canadian patient diagnosed with cryopyrin-associated periodic syndrome over a period of 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| canakinumab arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| canakinumab (company code: ACZ885D) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety & tolerability of canakinumab by measuring the maintenance of response over time using the Investigators Clinical Assessment of Disease Activity scale and the evaluation of serum inflammation markers CRP (C-Reactive Protein), SAA (Serum Amyloid A. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in long term maintenance of Health-Related Quality of Life and productivity measured from baseline to end of study. | Baseline, 18 months | |
| Treatment adherence with canakinumab for the duration of the study. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
"Other protocol-defined inclusion/exclusion criteria may apply"
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Children's Hospital, Department of Pediatrics | Calgary | Canada | ||||
| Queen Elizabeth II Hospital |
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| Halifax |
| Canada |
| 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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| ID | Term |
|---|---|
| C541220 | canakinumab |
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