NCT03932344

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 306 (actual)
• Sponsor: Swedish Orphan Biovitrum · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Still Disease, Juvenile Onset

Interventions

Type	Name	Description
DRUG	Anakinra	Anakinra according to prescription

Timeline

• Start date: 2019-04-10
• Primary completion: 2019-08-31
• Completion: 2019-08-31
• First posted: 2019-04-30
• Last updated: 2024-09-19

Locations

1 site across 1 country: Italy