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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Drug | This is a prospective observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in C-Reactive Protein (CRP) | CRP is a blood test that indicates levels of inflammation
| Baseline, 16 and 28 weeks |
| Change from baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS-CRP |
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Inclusion Criteria:
Exclusion Criteria:
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The subjects are biologic-naive AS patients who are <40 years old and have a time of less than 5 years since AS diagnosis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals, MD | Contact | +41613241111 | thomas.paul@novartis.com | |
| Novartis Pharmaceuticals | Contact | minsoo.jee@novartis.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Recruiting | Jinju | Gyeongsangnam-do | 52727 | South Korea | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32401062 | Background | Chimenti MS, Fonti GL, Conigliaro P, Sunzini F, Scrivo R, Navarini L, Triggianese P, Peluso G, Scolieri P, Caccavale R, Picchianti Diamanti A, De Martino E, Salemi S, Birra D, Altobelli A, Paroli M, Bruzzese V, Lagana B, Gremese E, Conti F, Afeltra A, Perricone R. One-year effectiveness, retention rate, and safety of secukinumab in ankylosing spondylitis and psoriatic arthritis: a real-life multicenter study. Expert Opin Biol Ther. 2020 Jul;20(7):813-821. doi: 10.1080/14712598.2020.1761957. Epub 2020 May 13. | |
| 32378070 |
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| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| D012216 | Rheumatic Diseases |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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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:
|
| 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 | Baseline, 16 and 28 weeks |
| Adverse events and Serious Adverse events | Incidence of Adverse events and Serious Adverse events | From baseline up to 28 weeks |
| Novartis Investigative Site |
| Recruiting |
| Busan |
| 49201 |
| South Korea |
| Background |
| Kiltz U, Sfikakis PP, Gaffney K, Sator PG, von Kiedrowski R, Bounas A, Gullick N, Conrad C, Rigopoulos D, Lespessailles E, Romanelli M, Ghislain PD, Brandt-Jurgens J, Rashkov R, Aassi M, Orsenigo R, Perella C, Pournara E, Gathmann S, Jagiello P, Veit J, Augustin M. Secukinumab Use in Patients with Moderate to Severe Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis in Real-World Setting in Europe: Baseline Data from SERENA Study. Adv Ther. 2020 Jun;37(6):2865-2883. doi: 10.1007/s12325-020-01352-8. Epub 2020 May 6. |
| 29781587 | Background | Dzubur E, Khalil C, Almario CV, Noah B, Minhas D, Ishimori M, Arnold C, Park Y, Kay J, Weisman MH, Spiegel BMR. Patient Concerns and Perceptions Regarding Biologic Therapies in Ankylosing Spondylitis: Insights From a Large-Scale Survey of Social Media Platforms. Arthritis Care Res (Hoboken). 2019 Feb;71(2):323-330. doi: 10.1002/acr.23600. |
| 32581090 | Background | Micheroli R, Tellenbach C, Scherer A, Burki K, Niederman K, Nissen MJ, Zufferey P, Exer P, Moller B, Kyburz D, Ciurea A. Effectiveness of secukinumab versus an alternative TNF inhibitor in patients with axial spondyloarthritis previously exposed to TNF inhibitors in the Swiss Clinical Quality Management cohort. Ann Rheum Dis. 2020 Sep;79(9):1203-1209. doi: 10.1136/annrheumdis-2019-215934. Epub 2020 Jun 24. |
| 29227352 | Background | Wang R, Ward MM. Epidemiology of axial spondyloarthritis: an update. Curr Opin Rheumatol. 2018 Mar;30(2):137-143. doi: 10.1097/BOR.0000000000000475. |
| 38108992 | Background | Mauro D, Forte G, Poddubnyy D, Ciccia F. The Role of Early Treatment in the Management of Axial Spondyloarthritis: Challenges and Opportunities. Rheumatol Ther. 2024 Feb;11(1):19-34. doi: 10.1007/s40744-023-00627-0. Epub 2023 Dec 18. |
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |