Kineret CAPS Post Authorisation Study

Completed

• Conditions: Cryopyrin-Associated Periodic Syndromes
• Interventions: Drug: anakinra (Kineret)

• Registration Number: NCT02326376
• Lead Sponsor: Swedish Orphan Biovitrum

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-29
• Study Start: 2015-04-24
• Primary Completion: 2019-09-12
• Study Completion: 2019-09-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-14
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CAPS patients	anakinra (Kineret)	CAPS patients treated with anakinra, using the Kineret graduated syringe

Primary Outcome Measures

Name	Time	Method
Rate of allergic reactions	3 years
Rate of injection site reactions	3 years
Rate of serious infections	3 years
Rate of new malignancies	3 years
Rate of medication errors including re-use of syringe	3 years

Trial Locations

Locations (1)

Swedish Orphan Biovitrum Investigational Site; 🇬🇧 London, United Kingdom