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

Last updated: April 29, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ankylosing Spondylitis

Arthritis And Arthritic Pain

Musculoskeletal Diseases

Treatment

Secukinumab

Clinical Study ID

NCT06905288
CAIN457HKR01
  • Ages 18-40
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Subjects diagnosed with ankylosing spondylitis (AS), as defined by the modified 1984New York criteria

  2. Subjects who have symptoms of active disease at screening and baseline, as evidencedby BASDAI score of ≥ 4

  3. Subjects who have never used TNFi, JAKi, or IL-17i drugs before

  4. Patients suitable for secukinumab treatment within the scope of labeling by theMinistry of Food and Drug Safety

  5. Subjects who have a time of less than 5 years since AS diagnosis

  6. Subjects who are above the age of 18 years and below 40years old

  7. Subjects who give informed consent form to participate in the study

Exclusion

Exclusion Criteria:

  1. Subjects who are in a medical or psychological condition which may prevent them fromparticipating in the study for the study period(28±4 weeks)

  2. Subjects who have congenital/traumatic spinal deformities

  3. Subjects currently enrolled in other clinical studies

  4. Subjects who have any contraindications to secukinumab treatment

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: Secukinumab
Phase:
Study Start date:
April 02, 2025
Estimated Completion Date:
June 30, 2026

Study Description

This study is an observational study to evaluate the effectiveness and safety of secukinumab in patients with ankylosing spondylitis who are naive to TNFi/JAKi/IL-17i in Korea. Subjects will be recruited from 10 institutions in Korea. The enrollment period is 8 months from the initiation at the first institution and the follow-up periods are 28 weeks(±4 weeks). Data will be gathered at initial visit, 16 weeks(±4 weeks), and 28 weeks(±4 weeks).

Secukinumab is prescribed within the scope of labeling approved in Korea.

Connect with a study center

  • Novartis Investigative Site

    Busan, 49201
    Korea, Republic of

    Active - Recruiting

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