About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Case-only
Prospective
Treatments tested in this trial
Secukinumab
DrugThis is a prospective observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.
Treatment groups
Trial outcomes
Primary outcomes
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
The BASDAI consists of 6 questions to measure the participant's symptoms and disease activity, and each question is evaluated using a numeric rating scale from 0 to 10 or a 10 cm Visual Analog Scale (VAS) with 0 being no problem and 10 being the worst problem
Secondary outcomes
Change from baseline in C-Reactive Protein (CRP)
CRP is a blood test that indicates levels of inflammation * CRP\< 5mg/L: Normal * CRP\>=5 mg/L: High
Change from baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS-CRP
ASDAS-CRP is the score for participant's evaluation of low back pain, peripheral pain/swelling, duration of morning stiffness, disease activity, and the disease activity score of ankylosing spondylitis calculated from CRP levels. Ranges for Disease activity status are defined as follows: * Disease activity status \<1.3: Inactive disease * Disease activity status 1.3-2.1: Low disease activity * Disease activity status 2.1-3.5: High disease activity * Disease activity status \>3.5 (No maximum limit): Very high disease activity
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) stratified by specific variables
The BASDAI consists of 6 questions to measure the participant's symptoms and disease activity, and each question is evaluated using a numeric rating scale from 0 to 10 or a 10 cm Visual Analog Scale (VAS) with 0 being no problem and 10 being the worst problem. Stratified by different baseline variables
Adverse events and Serious Adverse events
Incidence of Adverse events and Serious Adverse events
Sponsors and contacts
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