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.
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.
Study Type
OBSERVATIONAL
Enrollment
70
This is a prospective observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.
Novartis Investigative Site
Jinju, Gyeongsangnam-do, South Korea
RECRUITINGNovartis Investigative Site
Busan, South Korea
RECRUITINGNovartis Investigative Site
Gwangju, South Korea
RECRUITINGChange 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
Time frame: Baseline and 28 weeks
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
Time frame: Baseline, 16 and 28 weeks
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
Time frame: Baseline, 16 and 28 week
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
Time frame: Baseline, 16 and 28 weeks
Adverse events and Serious Adverse events
Incidence of Adverse events and Serious Adverse events
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Time frame: From baseline up to 28 weeks