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

Sobi

Status: Completed

Conditions: Still Disease, Juvenile Onset

Treatments: Drug: Anakinra

Study type: Observational

Funder types: Industry

Identifiers

NCT03932344

ENCEPP/SDPP/28378 (Other Identifier)

Sobi.Anakin-302

Details and patient eligibility

About

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.

Full 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.

Enrollment: 306 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

306 participants in 1 patient group

SJIA patients on Kineret treatment

Description:

SJIA patients on Kineret treatment enrolled in the Pharmachild JIA registry

Treatment:

Drug: Anakinra