Status:
NOT_YET_RECRUITING
Long Term Treatment Strategies and Effectiveness of Secukinumab in Patient With JIA Subtypes of JPsA and ERA: Study From German BIKER Registry.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Enthesitis-related Arthritis (ERA)
Juvenile Psoriatic Arthritis (JPsA)
Eligibility:
All Genders
6-17 years
Brief Summary
The goal of this study is to understand the long-term treatment strategies in children and adolescents diagnosed with ERA or JPsA who received secukinumab and achieved inactive disease and to evaluate...
Detailed Description
This is a multicenter, non-interventional cohort study with a combined data collection principle based on secondary use of data and primary data collection from the existing BIKER registry among pedia...
Eligibility Criteria
Inclusion
- In the BIKER registry, males and females ≥ 6 years old and ≤ 17 years old diagnosed with ERA according to the ILAR-criteria or JPsA according to the ILAR or the Vancouver criteria, who initiated at least one dose of secukinumab after it was approved in Germany and according to the label.
- Written informed consent from parent/legal guardian and assent from minor patient (11-17 years of age) for participating in the BIKER registry and for this study enrolment.
Exclusion
- Patients taking other biologic immunomodulating agent(s) or Janus kinase (JAK) inhibitors concomitantly with secukinumab at index date.
- Patients participating in any interventional trials at index date.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 18 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07190053
Start Date
December 1 2025
End Date
September 18 2029
Last Update
September 24 2025
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