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

NCT06905288 | Recruiting

• 1 other identifier: CAIN457HKR01
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Ankylosing Spondylitis

Keywords

Secukinumab; Ankylosing Spondylitis; Biologic Naive; Real World Study; Korea; Rheumatology; AS Research; Rheumatic Disease; Biologics; Clinical Effectiveness

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Change from baseline in C-Reactive Protein (CRP)

  Baseline, 16 and 28 weeks

• Change from baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS-CRP

  Baseline, 16 and 28 week

• Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) stratified by specific variables

  Baseline, 16 and 28 weeks

• Adverse events and Serious Adverse events

  From baseline up to 28 weeks

Study Arms (1)

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.

Drug: Secukinumab

Interventions

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.

group 1

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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
• Subjects who have a time of less than 5 years since AS diagnosis
• Subjects who are above the age of 18 years and below 40years old
• Subjects who give informed consent form to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Novartis Investigative Site

Jinju, Gyeongsangnam-do, 52727, South Korea

RECRUITING

Novartis Investigative Site

Busan, 49201, South Korea

RECRUITING

Related Publications (6)

• 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.

  PMID: 32401062 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.

  PMID: 32378070 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.

  PMID: 29781587 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.

  PMID: 32581090 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.

  PMID: 29227352 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.

  PMID: 38108992 BACKGROUND

MeSH Terms

Conditions

Spondylitis, Ankylosing; Rheumatic Diseases

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Novartis Pharmaceuticals, MD

CONTACT

+41613241111; thomas.paul@novartis.com

Novartis Pharmaceuticals

CONTACT

minsoo.jee@novartis.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: April 2, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

KR (2)