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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03932344
• Date of registration: 16/04/2019
• Prospective Registration: No
• Primary sponsor: Swedish Orphan Biovitrum
• Public title: Long-term Safety Study of Kineret® in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)
• Scientific title: A Non-interventional, Post-authorization Safety Study (PASS) to Evaluate Long-term Safety of Anakinra (Kineret®) in Patients With Systemic Juvenile Idiopathic Arthritis
• Date of first enrolment: April 10, 2019
• Target sample size: 306
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03932344
• Study type: Observational

Countries of recruitment

Italy

Contacts

• Name: Karin Franck-Larsson, MD
• Affiliation: Swedish Orphan Biovitrum

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Still Disease, Juvenile Onset

Intervention(s)

Drug: Anakinra

Primary Outcome(s)

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). [Time Frame: 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. [Time Frame: 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. [Time Frame: 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.]

Secondary ID(s)

ENCEPP/SDPP/28378

Sobi.Anakin-302

Source(s) of Monetary Support

Please refer to primary and secondary sponsors