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Completed

NCT Number: NCT01213641

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

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Key information

Conditions

Cryopyrin-associated Periodic Syndromes (CAPS) Chronic Disease Chronic Inducible Urticaria Chronic Urticaria Cold Urticaria Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cryopyrin-Associated Periodic Syndromes Disease Attributes Familial Cold Autoinflam Syn (FCAS) Genetic Diseases, Inborn Hereditary Autoinflammatory Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Muckle-wells Syn (MWS) Neonatal Onset Multisystem Inflam Disease (NOMID) Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Genetic Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative site, Bregenz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To monitor and further explore the overall safey of canakinumab focusing in serious infections

    Time frame: At least 5 years

Secondary outcomes

  1. 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

  2. Growth and development patterns of children aged 4 to 18 years of age exposed to Ilaris

    Time frame: at least 5 years

  3. Identify previously unrecognized serious adverse drug reactions in the treated population

    Time frame: at least 5 years

  4. Usage and patterns of dosing of Ilaris in routine clinical practice

    Time frame: at least 5 years

  5. Incidence of serious infections

    Time frame: at least 5 years

  6. Incidence of malignancies

    Time frame: at least 5 years

  7. Incidence of hypersensitivity reactions

    Time frame: at least 5 years

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: B-Confident

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Oct 4, 2010
Registry last updated
Mar 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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