Long-term Safety Study of Kineret® in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)

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.

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Key information

Conditions

Still Disease, Juvenile Onset Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Istituto G. Gaslini

Genova, 161 47, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anakinra

Drug

Anakinra according to prescription

Other names: Kineret

Primary outcomes

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.
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.
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.

Sponsors and collaborators

Lead sponsor

Swedish Orphan Biovitrum

Industry

Registry information

Official study title

A Non-interventional, Post-authorization Safety Study (PASS) to Evaluate Long-term Safety of Anakinra (Kineret®) in Patients With Systemic Juvenile Idiopathic Arthritis

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Apr 30, 2019
Registry last updated: Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed