NCT02326376

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2014

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 29, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

April 24, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

4.4 years

First QC Date

December 1, 2014

Last Update Submit

January 14, 2020

Conditions

Cryopyrin-Associated Periodic Syndromes

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

CAPS patients

CAPS patients treated with anakinra, using the Kineret graduated syringe

Drug: anakinra (Kineret)

Interventions

anakinra (Kineret)DRUG
Also known as: Kineret
CAPS patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All CAPS patients treated with Kineret at the selected sites.

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Swedish Orphan Biovitrum Investigational Site

Groningen, Netherlands

Location

Swedish Orphan Biovitrum Investigational Site

London, United Kingdom

Location

MeSH Terms

Conditions

Cryopyrin-Associated Periodic Syndromes

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Hereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue DiseasesChronic Inducible UrticariaChronic UrticariaUrticariaSkin Diseases, VascularCold UrticariaHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Marco Gattorno, MD

    IRCCS Istituto Giannina Gaslini

    PRINCIPAL INVESTIGATOR

  • Torbjörn Kullenberg, MD

    Swedish Orphan Biovitrum AB (publ)

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2014

First Posted

December 29, 2014

Study Start

April 24, 2015

Primary Completion

September 12, 2019

Study Completion

September 12, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

GB(1)NL(1)