Kineret CAPS Post Authorisation Study

Swedish Orphan Biovitrum12 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cryopyrin-Associated Periodic Syndromes

Interventions

anakinra (Kineret)DRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (2)

Swedish Orphan Biovitrum Investigational Site

Groningen, Netherlands

Swedish Orphan Biovitrum Investigational Site

London, United Kingdom

Outcomes

Primary Outcomes

Rate of serious infections

Time frame: 3 years

Rate of new malignancies

Time frame: 3 years

Rate of injection site reactions

Time frame: 3 years

Rate of allergic reactions

Time frame: 3 years

Rate of medication errors including re-use of syringe

Time frame: 3 years

Data from ClinicalTrials.gov

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