Long-term Safety Study of Kineret® in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT03932344 Completed April 30, 2019 November 14, 2019

study description
Brief Summary

The purpose of the study is to evaluate and characterize long-term safety of Kineret when used in standard clinical practice to treat patients with systemic juvenile idiopathic arthritis (SJIA). The study will be based on already available data from the Pharmachild juvenile idiopathic arthritis (JIA) registry which holds the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP) study seal.

Condition or Disease: Still Disease, Juvenile Onset
Intervention/treatment: Drug: Anakinra
Phase: N/A
Detailed Description

This is an international, non-interventional, single-armed, pharmacovigilance registry study
on long-term safety of Kineret utilizing already available data from the ENCePP certified
Pharmachild JIA registry.

The Paediatric Rheumatology International Trials Organisation (PRINTO) is a non-profit,
non-governmental, international research network with the goal to foster, facilitate and
co-ordinate the development, conduct, analysis, and reporting of multi-centers, international
clinical trials and/or outcome standardization studies in children with paediatric rheumatic
diseases.

The Pharmachild JIA registry, maintained by PRINTO, is a registry collecting data from
patients with JIA including patients with SJIA. In the Pharmachild JIA registry 40 countries
are participating of which 15 countries have collected data on Kineret treatment.

This study includes secondary use of data already available in the Pharmachild JIA registry.


study design
Study Type: Observational
Estimated Enrollment : 306 participants
Intervention Model : N/A
Masking: N/A
Primary Purpose: N/A
Official Title: A Non-interventional, Post-authorization Safety Study (PASS) to Evaluate Long-term Safety of Anakinra (Kineret®) in Patients With Systemic Juvenile Idiopathic Arthritis
Actual Study Start Date: April 2019
Actual Primary Completion Date: August 2019
Actual Study Completion Date: August 2019

Groups and Cohorts
Groups/Cohorts Intervention/treatment
: SJIA patients on Kineret treatment
SJIA patients on Kineret treatment enrolled in the Pharmachild JIA registry
Drug: Anakinra
Anakinra according to prescription
outcome measures
Primary Outcome Measures: 1. The occurrence of non-serious adverse events (AEs) of at least moderate severity and serious AEs (SAEs), including macrophage activation syndrome (MAS) as an event of special interest (ESI). [ Time Frame: The Pharmachild registry was set up in December 2011. The first Kineret treatment, retrospectively collected in the registry, occurred in 2004. Data collected in the registry up until September 30, 2018 will be used (secondary use) in this study. ]
The occurrence of non-serious AEs of at least moderate severity and serious AEs (SAEs), including MAS as an ESI. AEs (SAEs), including MAS as an ESI.
2. The duration of Kineret treatment in a real-world setting. [ Time Frame: The Pharmachild registry was set up in December 2011. The first Kineret treatment, retrospectively collected in the registry, occurred in 2004. Data collected in the registry up until September 30, 2018 will be used (secondary use) in this study. ]
The duration of Kineret treatment in a real-world setting.
3. The reasons for Kineret treatment discontinuation. [ Time Frame: The Pharmachild registry was set up in December 2011. The first Kineret treatment, retrospectively collected in the registry, occurred in 2004. Data collected in the registry up until September 30, 2018 will be used (secondary use) in this study. ]
The reasons for Kineret treatment discontinuation.

Eligibility Criteria
Ages Eligible for Study: (Child, Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Male and female patients with a diagnosis of SJIA as per the International League of Associations for Rheumatology (ILAR) classification criteria

- Included in the Pharmachild registry

- Ever treated with Kineret subsequently to SJIA diagnosis

Exclusion Criteria:

No specific exclusion criteria will be applied.


Contacts and Locations
Contacts
Locations
Italy IRCCS Istituto G. Gaslini Genova
Sponsors and Collaborators
Swedish Orphan Biovitrum
Investigator
Study Director : Karin Franck-Larsson, MD Swedish Orphan Biovitrum
More Information
Responsible Party : Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier : NCT03932344     
Other Study ID Numbers : Sobi.Anakin-302, ENCEPP/SDPP/28378
First Posted : April 30, 2019
Last Update Posted : November 14, 2019
Last Verified : November 2019
Individual Participant
Data (IPD) Sharing
Statement:
 
Plan to Share IPD: Undecided
Plan Description: It is not yet decided if there will be a plan to make IPD available.
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Swedish Orphan Biovitrum: Kineret
Anakinra
Long term safety
SJIA
Additional relevant MeSH terms :
Arthritis, Juvenile