Status:
RECRUITING
Real-world Study on Secukinumab Effectiveness in Biologic-naïve Ankylosing Spondylitis (AS) Patients in Korea.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18-40 years
Brief 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.
Detailed 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 recrui...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 2 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06905288
Start Date
April 2 2025
End Date
June 30 2026
Last Update
August 11 2025
Active Locations (2)
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1
Novartis Investigative Site
Busan, South Korea, 49201
2
Novartis Investigative Site
Jinju, South Korea, 660-702