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| ID | Type | Description | Link |
|---|---|---|---|
| ENCEPP/SDPP/28378 | Other Identifier | EU PAS register number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SJIA patients on Kineret treatment | SJIA patients on Kineret treatment enrolled in the Pharmachild JIA registry |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anakinra | Drug | Anakinra according to prescription |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 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 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 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 reasons for Kineret treatment discontinuation. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
No specific exclusion criteria will be applied.
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Data will be extracted and analyzed for all male and female patients with a diagnosis of SJIA as per the ILAR classification criteria included in the Pharmachild registry and who were ever treated with Kineret subsequently to SJIA diagnosis. That is, all eligible patients participating in the Pharmachild JIA registry study are included in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Study Physician | Swedish Orphan Biovitrum | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Istituto G. Gaslini | Genova | 161 47 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35105709 | Derived | Giancane G, Papa R, Vastert S, Bagnasco F, Swart JF, Quartier P, Anton J, Kamphuis S, Sanner H, Glerup M, De Benedetti F, Tsitsami E, Remesal A, Moreno E, De Inocencio J, Myrup C, Pallotti C, Kone-Paut I, Franck-Larsson K, Malmstrom H, Cederholm S, Pistorio A, Wulffraat N, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO). Anakinra in Patients With Systemic Juvenile Idiopathic Arthritis: Long-term Safety From the Pharmachild Registry. J Rheumatol. 2022 Apr;49(4):398-407. doi: 10.3899/jrheum.210563. Epub 2022 Feb 1. |
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It is not yet decided if there will be a plan to make IPD available.
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| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D053590 | Interleukin 1 Receptor Antagonist Protein |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011506 | Proteins |
| D001685 | Biological Factors |