CompletedNot Applicable

Kineret CAPS Post Authorisation Study

Netherlands, United Kingdom12 participantsStarted 2015-04-24

Plain-language summary

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.

Who can participate

SexALL

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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

What they're measuring

Rate of serious infections

Timeframe: 3 years

Rate of new malignancies

Timeframe: 3 years

Rate of injection site reactions

Timeframe: 3 years

Rate of allergic reactions

Timeframe: 3 years

Rate of medication errors including re-use of syringe

Timeframe: 3 years

Trial details

NCT IDNCT02326376

SponsorSwedish Orphan Biovitrum

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-09-12

View on ClinicalTrials.gov More Cryopyrin-Associated Periodic Syndromes trials