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NCT Number: NCT07130331

Efficacy and Influencing Factors of Secukinumab in Patients With Axial Spondyloarthritis

This study aimed to explore the efficacy and influencing factors of secukinumab in axSpA patients by conducting a real-world retrospective analysis.

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Key information

Conditions

Axial Spondylarthritis (axSpA) Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Secukinumab Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

About this study

Interleukin-17 (IL-17) plays a key role in axSpA joint inflammation, cartilage injury and bone remodeling.The 2022 ASAS-EULAR recommendations recommended the use of IL-17 inhibitors as first-line therapy for patients who have had an inadequate response to conventional agents including non-steroidal anti-inflammatory drugs (NSAIDs) and disease-modifying antirheumatic drugs (DMARDs). Secukinumab, a fully human monoclonal IgG1/κ antibody targeting IL-17A, was approved in the US in 2016 for the treatment of AS and in 2020 for the treatment of nr-axSpA. Although several studies have shown that secukinumab significantly reduces pain symptoms and diseases activity in axSpA patients, a significant proportion of patients experience treatment failure during the maintenance phase. This study aimed to explore the efficacy and influencing factors of secukinumab in axSpA patients by conducting a retrospective analysis in a real-world setting.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Meet the 2011 Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial spondyloarthritis
  • Treated with secukinumab with regular follow up
  • Patients who visited the Rheumatology clinic from Jun 2020 to Jul 2024 retrieved by Hospital Information System

Exclusion criteria

  • allergic to secukinumab
  • concomitant with other rheumatic immune diseases
  • patients with malignancies or serious infections
  • patients with poor compliance and lost to follow-up

Treatment and study plan

Secikinumab

Drug

secukinumab 150 mg at weeks 0, 1, 2, 3, and 4, followed by 150 mg s.c. every 4 weeks

Primary outcomes

  1. The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response

    Time frame: At week 12 after administration.

    Assessment of Spondylo Arthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a NRS; 2. Patient's assessment of back pain, measured on a NRS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by NRS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by NRS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant).

    ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the NRS signifies higher severity.

Other outcomes

  1. Laboratory parameters

    Time frame: At week 12 after administration

    White blood cell count, hemoglobin count, platelet count; level of lactate dehydrogenase, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, creatinine, uric acid, e-GFR, albumin, globulin, erythrocyte sedimentation rate, C-reactive protein

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study title

Efficacy and Influencing Factors Analysis of Secukinumab in Patients With Axial Spondyloarthritis in a Real-World Setting

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

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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