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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03932344
Recruitment Status : Enrolling by invitation
First Posted : April 30, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Swedish Orphan Biovitrum

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
Still Disease, Juvenile Onset Drug: Anakinra

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.


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Study Type : Observational
Estimated Enrollment : 307 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 10, 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019


Group/Cohort 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 Name: Kineret




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.



Information from the National Library of Medicine

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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03932344


Locations
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Italy
IRCCS Istituto G. Gaslini
Genova, Italy, 161 47
Sponsors and Collaborators
Swedish Orphan Biovitrum
Investigators
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Study Director: Karin Franck-Larsson, MD Swedish Orphan Biovitrum

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Responsible Party: Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier: NCT03932344     History of Changes
Other Study ID Numbers: Sobi.Anakin-302
ENCEPP/SDPP/28378 ( Other Identifier: EU PAS register number )
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Swedish Orphan Biovitrum:
SJIA
Kineret
Anakinra
Long term safety
Additional relevant MeSH terms:
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Arthritis, Juvenile
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents