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

Completed

• Conditions: Still Disease, Juvenile Onset
• Interventions: Drug: Anakinra

• Registration Number: NCT03932344
• Lead Sponsor: Swedish Orphan Biovitrum

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.

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 Timeline

• Study Start: 2019-04-10
• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-04-29
• Study First Posted: 2019-04-30
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-13
• Last Update Posted: 2019-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SJIA patients on Kineret treatment	Anakinra	SJIA patients on Kineret treatment enrolled in the Pharmachild JIA registry

Primary Outcome Measures

Name	Time	Method
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).	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.	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.	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.

Trial Locations

Locations (1)

IRCCS Istituto G. Gaslini; 🇮🇹 Genova, Italy