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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03932344

Recruitment Status Completed

First Posted April 30, 2019

Last update posted November 14, 2019

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:Still Disease, Juvenile Onset
  • Intervention/Treatment: Drug: Anakinra
  • Phase: N/A
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
  • Study Type: Observational
  • Actual Enrollment: 306 participants
  • Observational Model: Case-Only
  • Time Perspective: Retrospective
  • Official Title: A Non-interventional, Post-authorization Safety Study (PASS) to Evaluate Long-term Safety of Anakinra (Kineret®) in Patients With Systemic Juvenile Idiopathic Arthritis
  • Actual Study Start Date: April 2019
  • Actual Primary Completion Date: August 2019
  • Actual Study Completion Date: August 2019
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: SJIA patients on Kineret treatment
SJIA patients on Kineret treatment enrolled in the Pharmachild JIA registry
Drug: Anakinra
Anakinra according to prescription
Outcome Measures
  • Primary Outcome Measures: 1. 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 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.
  • 2. 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 duration of Kineret treatment in a real-world setting.
  • 3. 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. ]
    The reasons for Kineret treatment discontinuation.
Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: 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.
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
Contacts
Locations

Italy
IRCCS Istituto G. Gaslini
Genova

Sponsors and Collaborators

Swedish Orphan Biovitrum

Investigators

Study Director: Karin Franck-Larsson, MD Swedish Orphan Biovitrum

More Information
  • Responsible Party: Swedish Orphan Biovitrum
  • ClinicalTrials.gov Identifier: NCT03932344 History of Changes
  • Other Study ID Numbers: Sobi.Anakin-302, ENCEPP/SDPP/28378
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: November 14, 2019
  • Last Verified: November 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Plan Description: It is not yet decided if there will be a plan to make IPD available.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Swedish Orphan Biovitrum: Kineret
    Anakinra
    Long term safety
    SJIA
  • Additional relevant MeSH terms: Arthritis, Juvenile