Kineret CAPS Post Authorisation Study

Overview

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.

Full Title of 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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 12, 2019

Interventions

  • Drug: anakinra (Kineret)

Arms, Groups and Cohorts

  • CAPS patients
    • CAPS patients treated with anakinra, using the Kineret graduated syringe

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Swedish Orphan Biovitrum
  • Collaborator
    • Pediatric Rheumatology International Trials Organization
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Marco Gattorno, MD, Principal Investigator, IRCCS Istituto Giannina Gaslini
    • Torbjörn Kullenberg, MD, Study Director, Swedish Orphan Biovitrum AB (publ)

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