SOBI.ANAKIN-201 study
Research type
Research Study
Full title
A non-interventional, post authorization safety study (PASS) 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.
IRAS ID
163823
Contact name
Kristine Bäck
Contact email
Sponsor organisation
Swedish Orphan Biovitrum AB (publ)(SOBI)
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
This is an observational study to evaluate the safety of Kineret treatment in Cryopyrin Associated Periodic Syndromes (CAPS) patients in routine clinical care with regards to serious infections, malignancies, injection site reactions, allergic reactions and medication errors, including re-use of syringe.
Data will be collected from patients receiving Kineret using the graduated syringe after market authorisation.
The study is designed to determine how effective the current measures are to avoid medication errors, including re-use of syringe. The study also investigates the risks that have been identified previously. This information (i.e. serious infections, malignancies, injection site reactions (ISRs) and allergic reactions) can be obtained at the patients’ routine visits to the clinic.
Other objectives of the study are to evaluate the Kineret dosage over time, the proportions of patients who discontinue Kineret treatment temporarily or permanently and the proportion of patients who are transferred to another IL-1 blocking treatment.
Patients will be followed for 3 years or until the Kineret treatment is discontinued. Data will be collected at least once every year.REC name
London - Fulham Research Ethics Committee
REC reference
14/LO/1916
Date of REC Opinion
22 Oct 2014
REC opinion
Favourable Opinion