Kineret CAPS Post Authorisation Study

NCT ID: NCT02326376

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-24

Study Completion Date

2019-09-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Cryopyrin-Associated Periodic Syndromes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CAPS patients

CAPS patients treated with anakinra, using the Kineret graduated syringe

anakinra (Kineret)

Intervention Type DRUG

Interventions

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anakinra (Kineret)

Intervention Type DRUG

Other Intervention Names

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Kineret

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pediatric Rheumatology International Trials Organization

OTHER

Sponsor Role collaborator

Swedish Orphan Biovitrum

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marco Gattorno, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Istituto Giannina Gaslini

Torbjörn Kullenberg, MD

Role: STUDY_DIRECTOR

Swedish Orphan Biovitrum AB (publ)

Locations

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Swedish Orphan Biovitrum Investigational Site

Groningen, , Netherlands

Site Status

Swedish Orphan Biovitrum Investigational Site

London, , United Kingdom

Site Status

Countries

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Netherlands United Kingdom

Other Identifiers

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ENCEPP/SDPP/6366

Identifier Type: REGISTRY

Identifier Source: secondary_id

Sobi.Anakin-201

Identifier Type: -

Identifier Source: org_study_id

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