Evaluating secukinumab effectiveness in Korean patients with ankylosing spondylitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the effectiveness and safety of secukinumab in patients with ankylosing spondylitis (AS) who have never received treatment with TNF inhibitors, JAK inhibitors, or IL-17 inhibitors. Participants will be recruited from 10 institutions across Korea, with an enrollment period of 8 months and follow-up assessments at 16 and 28 weeks. The study will gather data on patient outcomes and treatment responses to secukinumab, which is approved for use in Korea.

Why it matters

Who can join: the full rules

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

Where it's running

• Novartis Investigative Site
  Jinju, Gyeongsangnam-do, South Korea Recruiting
• Novartis Investigative Site
  Busan, South Korea Recruiting
• Novartis Investigative Site
  Gwangju, South Korea Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals, MD
• Email: thomas.paul@novartis.com
• Phone: +41613241111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.