AzTrials
AzTrials

Axial Spondylarthritis (axSpA)NCT07130331

Efficacy and Influencing Factors of Secukinumab in Patients With Axial Spondyloarthritis

An observational study of Axial Spondylarthritis (axSpA) and Secukinumab, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Axial Spondylarthritis (axSpA), Secukinumab
What is being tested?
Secikinumab
How many people
200 participants
Where
1 siteChina
Study dates
1 Jun 2020to 1 Aug 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: adult axSpA patients treated with Secukinumab

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

Other trials in China

About this study

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

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

Read the detailed description

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.

Being tested
Secikinumab
Keywords
Axial spondyloarthritis, ASAS40
Medical subject headings
Axial Spondyloarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SecikinumabDrug

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

Study groups in NCT07130331
Study groupRoleWhat they receive
Patients with axial spondyloarthritisPatients with axial spondyloarthritis
Receives: Drug: Secikinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: At week 12 after administration.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2025
  2. Study start1 Jun 2020
  3. Primary completion1 Jul 2024
  4. Study completion1 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07130331
Sponsor's protocol ID
2025-0544-02
Status last verified
Jul 2025
First submitted
12 Aug 2025
Last updated
19 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rudwaleit M, van der Heijde D, Landewe R, Akkoc N, Brandt J, Chou CT, Dougados M, Huang F, Gu J, Kirazli Y, Van den Bosch F, Olivieri I, Roussou E, Scarpato S, Sorensen IJ, Valle-Onate R, Weber U, Wei J, Sieper J. The Assessment of SpondyloArthritis International Society classification criteria for peripheral spondyloarthritis and for spondyloarthritis in general. Ann Rheum Dis. 2011 Jan;70(1):25-31. doi: 10.1136/ard.2010.133645. Epub 2010 Nov 24.

    PubMed 21109520

  • Marzo-Ortega H, Sieper J, Kivitz A, Blanco R, Cohen M, Martin R, Readie A, Richards HB, Porter B; Measure 2 Study Group. Secukinumab and Sustained Improvement in Signs and Symptoms of Patients With Active Ankylosing Spondylitis Through Two Years: Results From a Phase III Study. Arthritis Care Res (Hoboken). 2017 Jul;69(7):1020-1029. doi: 10.1002/acr.23233. Epub 2017 Jun 7.

    PubMed 28235249

  • Danve A, Deodhar A. Treatment of axial spondyloarthritis: an update. Nat Rev Rheumatol. 2022 Apr;18(4):205-216. doi: 10.1038/s41584-022-00761-z. Epub 2022 Mar 10.

    PubMed 35273385

  • Ramiro S, Nikiphorou E, Sepriano A, Ortolan A, Webers C, Baraliakos X, Landewe RBM, Van den Bosch FE, Boteva B, Bremander A, Carron P, Ciurea A, van Gaalen FA, Geher P, Gensler L, Hermann J, de Hooge M, Husakova M, Kiltz U, Lopez-Medina C, Machado PM, Marzo-Ortega H, Molto A, Navarro-Compan V, Nissen MJ, Pimentel-Santos FM, Poddubnyy D, Proft F, Rudwaleit M, Telkman M, Zhao SS, Ziade N, van der Heijde D. ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update. Ann Rheum Dis. 2023 Jan;82(1):19-34. doi: 10.1136/ard-2022-223296. Epub 2022 Oct 21.

    PubMed 36270658

  • McGonagle DG, McInnes IB, Kirkham BW, Sherlock J, Moots R. The role of IL-17A in axial spondyloarthritis and psoriatic arthritis: recent advances and controversies. Ann Rheum Dis. 2019 Sep;78(9):1167-1178. doi: 10.1136/annrheumdis-2019-215356. Epub 2019 Jul 5.

    PubMed 31278139

  • Taams LS, Steel KJA, Srenathan U, Burns LA, Kirkham BW. IL-17 in the immunopathogenesis of spondyloarthritis. Nat Rev Rheumatol. 2018 Aug;14(8):453-466. doi: 10.1038/s41584-018-0044-2.

    PubMed 30006601

  • Chyuan IT, Chen JY. Role of Interleukin- (IL-) 17 in the Pathogenesis and Targeted Therapies in Spondyloarthropathies. Mediators Inflamm. 2018 Feb 12;2018:2403935. doi: 10.1155/2018/2403935. eCollection 2018.

    PubMed 29670461

  • Zhao J, Huang C, Huang H, Pan JK, Zeng LF, Luo MH, Liang GH, Yang WY, Liu J. Prevalence of ankylosing spondylitis in a Chinese population: a systematic review and meta-analysis. Rheumatol Int. 2020 Jun;40(6):859-872. doi: 10.1007/s00296-020-04537-0. Epub 2020 Mar 3.

    PubMed 32125505

  • Rudwaleit M, van der Heijde D, Landewe R, Listing J, Akkoc N, Brandt J, Braun J, Chou CT, Collantes-Estevez E, Dougados M, Huang F, Gu J, Khan MA, Kirazli Y, Maksymowych WP, Mielants H, Sorensen IJ, Ozgocmen S, Roussou E, Valle-Onate R, Weber U, Wei J, Sieper J. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009 Jun;68(6):777-83. doi: 10.1136/ard.2009.108233. Epub 2009 Mar 17.

    PubMed 19297344

  • Simone D, Al Mossawi MH, Bowness P. Progress in our understanding of the pathogenesis of ankylosing spondylitis. Rheumatology (Oxford). 2018 Aug 1;57(suppl_6):vi4-vi9. doi: 10.1093/rheumatology/key001.

    PubMed 30445483

Questions about this trial

What is this clinical trial studying?

An observational study of Axial Spondylarthritis (axSpA) and Secukinumab, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response (time frame: At week 12 after administration.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07130331, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in