Kineret CAPS Post Authorisation Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02326376

Enrollment

Registered

2014-12-29

Start date

2015-04-24

Completion date

2019-09-12

Last updated

2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cryopyrin-Associated Periodic Syndromes

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.

Interventions

DRUGanakinra (Kineret)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Netherlands, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026