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Completed

NCT Number: NCT02326376

Kineret CAPS Post Authorisation Study

A non-interventional, post authorization safety study to evaluate the safety of Kineret in the treatment of Cryopyrin Associated Periodic Syndromes (CAPS) in routine clinical care with regard to serious infections, malignancies, injection site reactions, allergic reactions and medication errors, including re-use of syringe.

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Key information

Conditions

Cryopyrin-associated Periodic Syndromes Chronic Disease Chronic Inducible Urticaria Chronic Urticaria Cold Urticaria Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Genetic Diseases, Inborn Hereditary Autoinflammatory Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases 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

Swedish Orphan Biovitrum Investigational Site, Groningen, Netherlands

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent by the patient and/or caregiver
  • Kineret treatment will be according to the Summary of Product Characteristics (SmPC), as confirmed by the Investigator

Exclusion criteria

  • None

Treatment and study plan

anakinra (Kineret)

Drug

Other names: Kineret

Primary outcomes

  1. Rate of serious infections

    Time frame: 3 years

  2. Rate of new malignancies

    Time frame: 3 years

  3. Rate of injection site reactions

    Time frame: 3 years

  4. Rate of allergic reactions

    Time frame: 3 years

  5. Rate of medication errors including re-use of syringe

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Swedish Orphan Biovitrum

Industry

Collaborators

  • Pediatric Rheumatology International Trials Organization

Registry information

Official study title

Non-interventional PASS to Evaluate Safety of Kineret in Treatment of CAPS in Routine Clinical Care With Regard to Serious Infections, Malignancies, Injection Site Reactions, Allergic Reactions, Medication Errors Including Re-use of Syringe

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 29, 2014
Registry last updated
Jan 18, 2020

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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