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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06905288
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