Kineret CAPS Post Authorisation Study

January 14, 2020 updated by: Swedish Orphan Biovitrum

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands
        • Swedish Orphan Biovitrum Investigational Site
  • United Kingdom
      • London, United Kingdom
        • Swedish Orphan Biovitrum Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All CAPS patients treated with Kineret at the selected sites.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CAPS patients
CAPS patients treated with anakinra, using the Kineret graduated syringe
Drug: anakinra (Kineret)
Other Names:
  • Kineret

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swedish Orphan Biovitrum

Collaborators

Pediatric Rheumatology International Trials Organization

Investigators

  • Principal Investigator: Marco Gattorno, MD, IRCCS Istituto Giannina Gaslini
  • Study Director: Torbjörn Kullenberg, MD, Swedish Orphan Biovitrum AB (publ)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2015

Primary Completion (Actual)

September 12, 2019

Study Completion (Actual)

September 12, 2019

Study Registration Dates

First Submitted

December 1, 2014

First Submitted That Met QC Criteria

December 22, 2014

First Posted (Estimate)

December 29, 2014

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 14, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sobi.Anakin-201
  • ENCEPP/SDPP/6366 (Registry Identifier: EU PAS Registry No)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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