Kineret CAPS Post Authorisation Study | NCT02326376

Studies
Kineret CAPS Post Authorisation Study

NCT02326376

Sponsor

Swedish Orphan Biovitrum

Status

Completed

Last Update Posted

Jan 18, 2020Actual

Enrollment

12Actual

Phase

Not provided

Conditions

Cryopyrin-Associated Periodic Syndromes

Interventions

anakinra (Kineret)

Countries

Netherlands
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ENCEPP/SDPP/6366	Registry Identifier	EU PAS Registry No

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 24, 2015Actual

Primary Completion Date

Sep 12, 2019Actual

Completion Date

Sep 12, 2019Actual

First Submitted Date

Dec 1, 2014

First Submission Date that Met QC Criteria

Dec 22, 2014

First Posted Date

Dec 29, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2020

Last Update Posted Date

Jan 18, 2020Actual

Name	Class
Pediatric Rheumatology International Trials Organization	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CAPS patients		CAPS patients treated with anakinra, using the Kineret graduated syringe	Drug: anakinra (Kineret)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
anakinra (Kineret)	Drug		CAPS patients	Kineret

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All CAPS patients treated with Kineret at the selected sites.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Swedish Orphan Biovitrum Investigational Site		Groningen			Netherlands
Swedish Orphan Biovitrum Investigational Site

Condition Browse Module

MeSH Terms

ID	Term
D056587	Cryopyrin-Associated Periodic Syndromes

Ancestor Terms

ID	Term
D056660	Hereditary Autoinflammatory Diseases
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D012873	Skin Diseases, Genetic

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D053590	Interleukin 1 Receptor Antagonist Protein

Ancestor Terms

ID	Term
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided