Clinical trial NCT06905288: Real-world Study on Secukinumab Effectiveness in Biologic-naïve Ankylosing Spondylitis (AS) Patients in Korea.
Official title: Real-world Observational Study to Evaluate the Effectiveness of Secukinumab in Biologic-naive Ankylosing Spondylitis Patients in Korea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ankylosing Spondylitis
Keywords: Secukinumab
Ankylosing Spondylitis
Biologic Naive
Real World Study
Korea
Rheumatology
AS Research
Rheumatic Disease
Biologics
Clinical Effectiveness
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2025-04-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects are biologic-naive AS patients who are \<40 years old and have a time of less than 5 years since AS diagnosis.

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 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.

Eligibility criteria: Inclusion Criteria:

1. Subjects diagnosed with ankylosing spondylitis (AS), as defined by the modified 1984 New York criteria
2. Subjects who have symptoms of active disease at screening and baseline, as evidenced by 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 the Ministry 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 Criteria:

1. 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)
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

Primary outcomes:
measure: Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Baseline and 28 weeks
Secondary outcomes:
measure: Change from baseline in C-Reactive Protein (CRP)
timeFrame: Baseline, 16 and 28 weeks
measure: Change from baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS-CRP
timeFrame: Baseline, 16 and 28 week
measure: Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) stratified by specific variables
timeFrame: Baseline, 16 and 28 weeks
measure: Adverse events and Serious Adverse events
timeFrame: From baseline up to 28 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Novartis Investigative Site
Study officials:
References:
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citation: Micheroli R, Tellenbach C, Scherer A, Burki K, Niederman K, Nissen MJ, Zufferey P, Exer P, Moller B, Kyburz D, Ciurea A. Effectiveness of secukinumab versus an alternative TNF inhibitor in patients with axial spondyloarthritis previously exposed to TNF inhibitors in the Swiss Clinical Quality Management cohort. Ann Rheum Dis. 2020 Sep;79(9):1203-1209. doi: 10.1136/annrheumdis-2019-215934. Epub 2020 Jun 24.
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