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

March 25, 2016 updated by: Novartis Pharmaceuticals

An Open-label, Long-term, Prospective, Observational Study to Monitor the Safety and Effectiveness of Ilaris in CAPS Patients

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

288

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Bregenz, Austria
        • Novartis Investigative Site
      • Vienna, Austria
        • Novartis Investigative Site
  • Germany
      • 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
        • Novartis Investigative Site
  • Norway
      • Oslo, Norway
        • Novartis Investigative Site
  • Switzerland
      • Aarau, Switzerland
        • Novartis Investigative Site
      • Basel, Switzerland
        • Novartis Investigative Site
      • Geneve, Switzerland
        • Novartis Investigative Site
      • Lausanne, Switzerland
        • Novartis Investigative Site
  • United States
    • Arizona
      • Little Rock, Arizona, United States, 72205
        • Little Rock Allergy and Asthma Clinic
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Allergy Center at Brookstone
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - St. Lukes Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To monitor and further explore the overall safey of canakinumab focusing in serious infections
Time Frame: At least 5 years
At least 5 years

Secondary Outcome Measures

Outcome Measure
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)
Time Frame: At least 5 years
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
at least 5 years
Identify previously unrecognized serious adverse drug reactions in the treated population
Time Frame: at least 5 years
at least 5 years
Usage and patterns of dosing of Ilaris in routine clinical practice
Time Frame: at least 5 years
at least 5 years
Incidence of serious infections
Time Frame: at least 5 years
at least 5 years
Incidence of malignancies
Time Frame: at least 5 years
at least 5 years
Incidence of hypersensitivity reactions
Time Frame: at least 5 years
at least 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

September 30, 2010

First Submitted That Met QC Criteria

October 1, 2010

First Posted (ESTIMATE)

October 4, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 28, 2016

Last Update Submitted That Met QC Criteria

March 25, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CACZ885D2401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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