RecruitingNCT06905288

Real-world Study on Secukinumab Effectiveness in Biologic-naïve Ankylosing Spondylitis (AS) Patients in Korea.

Real-world Observational Study to Evaluate the Effectiveness of Secukinumab in Biologic-naive Ankylosing Spondylitis Patients in Korea


Sponsor

Novartis Pharmaceuticals

Enrollment

70 participants

Start Date

Apr 2, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This is an observational study to evaluate the effectiveness and safety of secukinumab in participants with AS who have never used TNFi, JAKi, or IL-17i drugs before.


Eligibility

Min Age: 18 YearsMax Age: 40 Years

Inclusion Criteria7

  • Subjects diagnosed with ankylosing spondylitis (AS), as defined by the modified 1984 New York criteria
  • Subjects who have symptoms of active disease at screening and baseline, as evidenced by BASDAI score of ≥ 4
  • Subjects who have never used TNFi, JAKi, or IL-17i drugs before
  • Patients suitable for secukinumab treatment within the scope of labeling by the Ministry of Food and Drug Safety
  • Subjects who have a time of less than 5 years since AS diagnosis
  • Subjects who are above the age of 18 years and below 40years old
  • Subjects who give informed consent form to participate in the study

Exclusion Criteria4

  • Subjects who are in a medical or psychological condition which may prevent them from participating in the study for the study period(28±4 weeks)
  • Subjects who have congenital/traumatic spinal deformities
  • Subjects currently enrolled in other clinical studies
  • Subjects who have any contraindications to secukinumab treatment

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Interventions

DRUGSecukinumab

This is a prospective observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.


Locations(2)

Novartis Investigative Site

Jinju, Gyeongsangnam-do, South Korea

Novartis Investigative Site

Busan, South Korea

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NCT06905288


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