Long-term Safety Study of Kineret® in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)
Study Details
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 | Intervention/Treatment | Phase |
|---|---|---|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| SJIA patients on Kineret treatment SJIA patients on Kineret treatment enrolled in the Pharmachild JIA registry |
Drug: Anakinra
Anakinra according to prescription
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IRCCS Istituto G. Gaslini | Genova | Italy | 161 47 |
Sponsors and Collaborators
- Swedish Orphan Biovitrum
Investigators
- Study Director: Karin Franck-Larsson, MD, Swedish Orphan Biovitrum
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Sobi.Anakin-302
- ENCEPP/SDPP/28378