Ankylosing Spondylitis
Conditions
Keywords
Secukinumab, Ankylosing Spondylitis, Biologic Naive, Real World Study, Korea, Rheumatology, AS Research, Rheumatic Disease, Biologics, Clinical Effectiveness
Brief 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.
Detailed 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.
Interventions
DRUGSecukinumab
This is a prospective observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Baseline and 28 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in C-Reactive Protein (CRP) | Baseline, 16 and 28 weeks | 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 | Baseline, 16 and 28 week | 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 | Baseline, 16 and 28 weeks | 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 | From baseline up to 28 weeks | Incidence of Adverse events and Serious Adverse events |
Countries
South Korea
Contacts
CONTACTNovartis Pharmaceuticals, MD
CONTACTNovartis Pharmaceuticals
Outcome results
None listed