Real-world Study on Secukinumab Effectiveness in Biologic-naïve Ankylosing Spondylitis (AS) Patients in Korea. (ONSET)

Novartis

Status: Enrolling

Conditions: Ankylosing Spondylitis

Treatments: Drug: Secukinumab

Study type: Observational

Funder types: Industry

Identifiers

NCT06905288

CAIN457HKR01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

70 participants in 1 patient group

group 1

Description:

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.

Treatment:

Drug: Secukinumab