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NCT Number: NCT06905288

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

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.

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Jinju, Gyeongsangnam-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    Time frame: 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 outcomes

  1. Change from baseline in C-Reactive Protein (CRP)

    Time frame: Baseline, 16 and 28 weeks

    CRP is a blood test that indicates levels of inflammation

    • CRP< 5mg/L: Normal
    • CRP>=5 mg/L: High

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

    Time frame: 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

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

    Time frame: 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

  4. Adverse events and Serious Adverse events

    Time frame: From baseline up to 28 weeks

    Incidence of Adverse events and Serious Adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

Novartis Pharmaceuticals, MD

CONTACT

[email protected]

+41613241111

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Real-world Observational Study to Evaluate the Effectiveness of Secukinumab in Biologic-naive Ankylosing Spondylitis Patients in Korea

Acronym: ONSET

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2025
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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