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

NCT07190053 | Not Yet Recruiting

• 1 other identifier: CAIN457V12401
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

ERA,; JPsA,; secukinumab

Outcome Measures

Primary Outcomes (2)

• Number of patients who had the following long-term treatment strategy after achieving inactive disease on secukinumab

  Number of patients who had the following long-term treatment strategy after achieving inactive disease on secukinumab * Secukinumab treatment remained unchanged or dose was increased. * Dose tapering of secukinumab (by dose reduction or prolongation of treatment interval). * Increase of secukinumab dose after a tapering period. * Initiation of other biologics after a tapering period. * Entering a secukinumab-free period due to achieving inactive disease or clinical remission (stratified by those who discontinue secukinumab due to achieving inactive disease without achieving clinical remission and those who achieve clinical remission) * Re-initiation of secukinumab after a secukinumab-free period * Initiation of other biologics after a secukinumab-free period

  Up to 5 years

• Number of patients experiencing at least one episode of flare

  Number of patients experiencing at least one episode of flare: * Following inactive disease for patients whose secukinumab treatment remained unchanged or increased dose. * Following the start of tapering or discontinuation of secukinumab treatment after achieving inactive disease

  Up to 5 years

Secondary Outcomes (27)

• Number of patients with following secukinumab treatment patterns

  every 3 months after index date until end of follow-up, up to 5 years

• Number of participants by reason for changes to treatment strategy

  every 3 months after index date until end of follow-up, up to 5 years

• Number of patients achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 criteria at follow-up

  Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years

• Number of patients achieving at least minimal disease activity

  Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years

• Number of patients achieving inactive disease

  Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years

Study Arms (1)

Secukinumab

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

Other: Secukinumab

Interventions

Secukinumab OTHER

This is an observational study, there is no treatment allocation

Secukinumab

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents diagnosed with ERA or JPsA JIA categories who received secukinumab

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: September 24, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): September 18, 2029
• Study Completion (Estimated): September 18, 2029
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share