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

NCT ID: NCT01213641

Last Updated: 2016-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

288 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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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 Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Little Rock Allergy and Asthma Clinic

Little Rock, Arizona, United States

Site Status

Allergy Center at Brookstone

Columbus, Georgia, United States

Site Status

Rush Presbyterian - St. Lukes Medical Center

Chicago, Illinois, United States

Site Status

Novartis Investigative site

Bregenz, , Austria

Site Status

Novartis Investigative site

Vienna, , Austria

Site Status

Novartis Investigative site

Dresden, , Germany

Site Status

Novartis Investigative site

Hamburg, , Germany

Site Status

Novartis Investigative site

Heidelberg, , Germany

Site Status

Novartis Investigative site

Herne, , Germany

Site Status

Novartis Investigative site

Kiel, , Germany

Site Status

Novartis Investigative site

Schweinfurt, , Germany

Site Status

Novartis Investigative site

Tübingen, , Germany

Site Status

Novartis Investigative site

Oslo, , Norway

Site Status

Novartis Investigative site

Aarau, , Switzerland

Site Status

Novartis Investigative site

Basel, , Switzerland

Site Status

Novartis Investigative site

Geneva, , Switzerland

Site Status

Novartis Investigative site

Lausanne, , Switzerland

Site Status

Countries

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United States Austria Germany Norway Switzerland

References

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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.

Reference Type DERIVED
PMID: 34001647 (View on PubMed)

Other Identifiers

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CACZ885D2401

Identifier Type: -

Identifier Source: org_study_id

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