Real-world Observational Study to Evaluate the Effectiveness of Secukinumab in Biologic-naive Ankylosing Spondylitis Patients in Korea
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Republic of Korea
Novartis Investigative Site
RECRUITING
Busan
Novartis Investigative Site
RECRUITING
Jinju
Contact Information
Primary
Novartis Pharmaceuticals, MD
thomas.paul@novartis.com
+41613241111
Backup
Novartis Pharmaceuticals
minsoo.jee@novartis.com
Time Frame
Start Date:2025-04-02
Estimated Completion Date:2026-06-30
Participants
Target number of participants:70
Treatments
group 1
The group will include subjects diagnosed with ankylosing spondylitis (AS) according to the modified 1984 New York criteria, who exhibit symptoms of active disease at both screening and baseline, as indicated by a BASDAI score of ≥ 4. Eligible participants must be biologic-naive, meaning they have no prior use of TNF inhibitors (TNFi), JAK inhibitors (JAKi), or IL-17 inhibitors (IL-17i). Additionally, patients must be deemed suitable for secukinumab treatment as per the labeling guidelines set by the Ministry of Food and Drug Safety. The study will focus on individuals with a time since AS diagnosis of less than 5 years, aged between 18 and 40 years.