Long Term Treatment Strategies and Effectiveness of Secukinumab in Patient With JIA Subtypes of JPsA and ERA: Study From German BIKER Registry.

NCT ID: NCT07190053

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2029-09-18

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 the long-term treatment effectiveness of secukinumab in the ERA or JPsA patients in the postauthorization setting.

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 pediatric patients with a recorded diagnosis of ERA or JPsA who have been treated with secukinumab.

The primary objective of this study is to characterize potentially less demanding long-term treatment strategies (e.g., dose tapering, treatment withdrawal followed by treatment re-initiation as needed) and to characterize their effectiveness (evaluated by occurrence of disease flares) in children and adolescents with Enthesitis-Related Arthritis (ERA) or Juvenile Psoriatic Arthritis (JPsA) categories documented in the German Biologics in pediatric rheumatology (BIKER) registry who received secukinumab and achieved inactive disease.

The date of first treatment/prescription of secukinumab will be considered as the index date. The baseline period to evaluate the demographic and clinical characteristics includes the index date and up to 1 year prior to the index date; if no record is available at the index date whichever record is closest to the index date will be used. For JIA-related variables, such as JIA-related manifestations, the evaluation will not have a specific time limit prior to the index date."

Conditions

Enthesitis-related Arthritis (ERA); Juvenile Psoriatic Arthritis (JPsA)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Secukinumab

All children and adolescents with ERA or JPsA who received at least one dose of secukinumab.

Secukinumab

Intervention Type: OTHER

This is an observational study, there is no treatment allocation

Interventions

Secukinumab

This is an observational study, there is no treatment allocation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Central Contacts

Novartis Pharmaceuticals

Role: CONTACT

novartis.email@novartis.com

+41613241111

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

CAIN457V12401

Identifier Type: -

Identifier Source: org_study_id