Clinical Outcomes and Safety: A Registry Study of Ilaris (Canakinumab) Patients (B-Confident)
This study is currently recruiting participants.
Verified April 2012 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01213641
First received: September 30, 2010
Last updated: April 27, 2012
Last verified: April 2012
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Purpose
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 |
|---|
|
Cryopyrin-associated Periodic Syndromes (CAPS) Familial Cold Autoinflam Syn (FCAS) Muckle-wells Syn (MWS) Neonatal Onset Multisystem Inflam Disease (NOMID) |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial cold autoinflammatory syndrome
familial Mediterranean fever
Muckle-Wells syndrome
neonatal onset multisystem inflammatory disease
MedlinePlus related topics:
Allergy
Drug Information available for:
Canakinumab
U.S. FDA Resources
Further study details as provided by Novartis:
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
| Estimated Enrollment: | 200 |
| Study Start Date: | November 2009 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
Eligibility| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01213641
Contacts
| Contact: Novartis Pharmaceuticals | +41-61-324-1111 |
Locations
| United States, Arizona | |
| Little Rock Allergy and Asthma Clinic | Recruiting |
| Little Rock, Arizona, United States, 72205 | |
| United States, Georgia | |
| Allergy Center at Brookstone | Recruiting |
| Columbus, Georgia, United States, 31904 | |
| United States, Illinois | |
| Rush Presbyterian - St. Lukes Medical Center | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Austria | |
| Novartis Investigative site | Recruiting |
| Bregenz, Austria | |
| Novartis Investigative site | Recruiting |
| Vienna, Austria | |
| Germany | |
| Novartis Investigative site | Recruiting |
| Dresden, Germany | |
| Novartis Investigative site | Recruiting |
| Hamburg, Germany | |
| Novartis Investigative site | Recruiting |
| Heidelberg, Germany | |
| Novartis Investigative site | Recruiting |
| Herne, Germany | |
| Novartis Investigative site | Recruiting |
| Kiel, Germany | |
| Novartis Investigative site | Recruiting |
| Schweinfurt, Germany | |
| Novartis Investigative site | Recruiting |
| Tuebingen, Germany | |
| Norway | |
| Novartis Investigative site | Recruiting |
| Oslo, Norway | |
| Switzerland | |
| Novartis Investigative site | Recruiting |
| Aarau, Switzerland | |
| Novartis Investigative site | Recruiting |
| Basel, Switzerland | |
| Novartis Investigative site | Recruiting |
| Geneve, Switzerland | |
| Novartis Investigative site | Recruiting |
| Lausanne, Switzerland | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01213641 History of Changes |
| Other Study ID Numbers: | CACZ885D2401 |
| Study First Received: | September 30, 2010 |
| Last Updated: | April 27, 2012 |
| Health Authority: | Switzerland: Swissmedic Germany: Paul-Ehrlich-Institut Germany: BfArM |
Keywords provided by Novartis:
|
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:
|
Cryopyrin-Associated Periodic Syndromes Hereditary Autoinflammatory Diseases Genetic Diseases, Inborn Skin Diseases, Genetic Skin Diseases |
ClinicalTrials.gov processed this record on June 17, 2013