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AzTrials

Spondyloarthritis (SpA)NJSpAMNCT07230327

Whole Body MRI for Non-invasive Lesion Detection and Therapy Follow-up: Study With Patients With Radiographic axSpA and Non-radiographic axSpA

An observational study of Spondyloarthritis (SpA) and Whole-body MRI (WBMRI), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to further improve and expand the WB-MRI imaging evaluation cohort of axSpA patients to complete dynamic follow-up and condition assessment. Based on the WB-MRI features, the association of WB-MRI signs with disease activity, inflammation, and structural damage will be analyzed. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Whole body MRI
Type of treatment
Surgery or procedure
How many people
100 participants
Where
1 siteChina
Study dates
1 Jan 2022to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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: Exclusion Criteria: Unable to provide written consent Unable to undergo MRI examination Pregnancy Unable to read and/or write Chinese

Who may be able to join

  • Include newly referred patients if:
  • The onset of symptoms (back pain/arthritis/enthesitis) < 45 years
  • Undiagnosed disease with the following symptoms:
  • chronic back pain (duration of back pain more than 3 months) and/or peripheral arthritis (asymmetric arthritis/predominantly of the lower limbs) and/or enthesitis and/or dactylitis

Who cannot join

  • And diagnosed with non-radiographic or radiographic axial SpA

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wenfeng Tan, Dr contact

+8618061202878

tw2006@njmu.edu.cn

China1 site, 1 recruiting

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029

    Lingxiao Xu, Dr, +8613913017356, lingxiao_jsph@126.com

    Recruiting

Other trials in China

About this study

Official title: Research on a New Disease Activity Assessment System for axSpA Based on Whole-body Magnetic Resonance Imaging Cohort

This study aims to further improve and expand the WB-MRI imaging evaluation cohort of axSpA patients to complete dynamic follow-up and condition assessment. Based on the WB-MRI features, the association of WB-MRI signs with disease activity, inflammation, and structural damage will be analyzed. At the same time, in-depth data mining was conducted and machine learning was used to construct a new axSpA disease activity assessment model based on WB-MRI data, and the accuracy and reliability of the model were clearly evaluated in the discovery cohort and validation cohort.

Read the detailed description

Axial spondyloarthritis (axSpA) is a common clinical chronic inflammatory joint disease with a high disability rate. Current assessment of axSpA disease activity mainly relies on patients' self-reported symptoms and signs, which has poor accuracy and reliability. At the same time, existing assessment methods fail to include some important disease characteristics of axSpA, such as active spinal inflammation and enthesitis. Therefore, there is an urgent need to establish a new axSpA disease activity assessment system.

With the development of imaging technology, whole-body MRI (WB-MRI) scanning technology is highly sensitive, can detect multiple parts at the same time, and can fuse multiple sequence images to make disease location and diagnosis more accurate. Currently, Much attention has been paid to it, but it has been less studied in axSpA.

This study established a disease activity assessment model based on WB-MRI imaging assessment, which will provide a new, effective and accurate method for axSpA disease assessment. At the same time, it will provide theoretical basis and practical basis for further understanding of the clinical characteristics of axSpA, the relationship between inflammation and structural damage.

Being tested
Whole body MRI
Medical subject headings
Spondylarthritis

What participants receive

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

  • Whole body MRIProcedure or surgery

    These studies will be performed on a 3Tesla (T) MR system (Achieva, Philips Medical Systems) for all patients.

What is being measured

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

  1. WB-MRI imaging characteristics of patients with axSpA.

    Compare the correlation between WB-MRI changes and disease activity, disease progression and structural damage at baseline and after 2 years of follow-up.

    Measured: Two years

Secondary outcomes (1)

  1. The correlation between WB-MRI changes and disease activities

    To elucidate the correlation between WB-MRI changes and inflammation, structural damage and disease activity in patients with axSpA.

    Measured: Five yeas

Timeline

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

  1. First posted17 Nov 2025
  2. Study start1 Jan 2022
  3. Primary completionJan 2026 (estimated)
  4. Study completionDec 2026 (estimated)

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 only
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07230327
Sponsor's protocol ID
SPA-JS
Acronym
NJSpAM
Status last verified
Nov 2025
First submitted
15 Jan 2024
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Treitl KM, Ricke J, Baur-Melnyk A. Whole-body magnetic resonance imaging (WBMRI) versus whole-body computed tomography (WBCT) for myeloma imaging and staging. Skeletal Radiol. 2022 Jan;51(1):43-58. doi: 10.1007/s00256-021-03799-4. Epub 2021 May 24.

    PubMed 34031705

  • Hynes JP, Hughes N, Cunningham P, Kavanagh EC, Eustace SJ. Whole-body MRI of bone marrow: A review. J Magn Reson Imaging. 2019 Dec;50(6):1687-1701. doi: 10.1002/jmri.26759. Epub 2019 Apr 23.

    PubMed 31016800

  • Guo Z, Li B, Zhang Y, Kong C, Liu Y, Qu J, Zhan Y, Shen Z, Lei X. Peripheral enthesitis assessed by whole-body MRI in axial spondyloarthritis: Distribution and diagnostic value. Front Immunol. 2022 Aug 23;13:976800. doi: 10.3389/fimmu.2022.976800. eCollection 2022.

    PubMed 36081521

  • Poggenborg RP, Eshed I, Ostergaard M, Sorensen IJ, Moller JM, Madsen OR, Pedersen SJ. Enthesitis in patients with psoriatic arthritis, axial spondyloarthritis and healthy subjects assessed by 'head-to-toe' whole-body MRI and clinical examination. Ann Rheum Dis. 2015 May;74(5):823-9. doi: 10.1136/annrheumdis-2013-204239. Epub 2014 Jan 3.

    PubMed 24389294

  • Krabbe S, Ostergaard M, Eshed I, Sorensen IJ, Jensen B, Moller JM, Balding L, Madsen OR, Asmussen K, Eng G, Jorgensen NR, Pedersen SJ. Whole-body Magnetic Resonance Imaging in Axial Spondyloarthritis: Reduction of Sacroiliac, Spinal, and Entheseal Inflammation in a Placebo-controlled Trial of Adalimumab. J Rheumatol. 2018 May;45(5):621-629. doi: 10.3899/jrheum.170408. Epub 2018 Feb 15.

    PubMed 29449506

  • Karpitschka M, Godau-Kellner P, Kellner H, Horng A, Theisen D, Glaser C, Brandlhuber B, Reiser M, Weckbach S. Assessment of therapeutic response in ankylosing spondylitis patients undergoing anti-tumour necrosis factor therapy by whole-body magnetic resonance imaging. Eur Radiol. 2013 Jul;23(7):1773-84. doi: 10.1007/s00330-013-2794-1. Epub 2013 Mar 15.

    PubMed 23494493

  • Poggenborg RP, Pedersen SJ, Eshed I, Sorensen IJ, Moller JM, Madsen OR, Thomsen HS, Ostergaard M. Head-to-toe whole-body MRI in psoriatic arthritis, axial spondyloarthritis and healthy subjects: first steps towards global inflammation and damage scores of peripheral and axial joints. Rheumatology (Oxford). 2015 Jun;54(6):1039-49. doi: 10.1093/rheumatology/keu439. Epub 2014 Nov 26.

    PubMed 25431482

  • Weckbach S. Whole-body MRI for inflammatory arthritis and other multifocal rheumatoid diseases. Semin Musculoskelet Radiol. 2012 Nov;16(5):377-88. doi: 10.1055/s-0032-1329881. Epub 2012 Dec 4.

    PubMed 23212873

  • Althoff CE, Sieper J, Song IH, Haibel H, Weiss A, Diekhoff T, Rudwaleit M, Freundlich B, Hamm B, Hermann KG. Active inflammation and structural change in early active axial spondyloarthritis as detected by whole-body MRI. Ann Rheum Dis. 2013 Jun;72(6):967-73. doi: 10.1136/annrheumdis-2012-201545. Epub 2012 Jun 26.

    PubMed 22736088

  • Krabbe S, Eshed I, Sorensen IJ, Jensen B, Moller JM, Balding L, Madsen OR, Pedersen SJ, Ostergaard M. Whole-body Magnetic Resonance Imaging Inflammation in Peripheral Joints and Entheses in Axial Spondyloarthritis: Distribution and Changes during Adalimumab Treatment. J Rheumatol. 2020 Jan;47(1):50-58. doi: 10.3899/jrheum.181159. Epub 2019 Apr 1.

    PubMed 30936290

  • Weiss BG, Bachmann LM, Pfirrmann CW, Kissling RO, Zubler V. Whole Body Magnetic Resonance Imaging Features in Diffuse Idiopathic Skeletal Hyperostosis in Conjunction with Clinical Variables to Whole Body MRI and Clinical Variables in Ankylosing Spondylitis. J Rheumatol. 2016 Feb;43(2):335-42. doi: 10.3899/jrheum.150162. Epub 2015 Dec 15.

    PubMed 26669910

  • Althoff CE, Sieper J, Song IH, Weiss A, Diekhoff T, Haibel H, Hamm B, Hermann KG. Comparison of Clinical Examination versus Whole-body Magnetic Resonance Imaging of Enthesitis in Patients with Early Axial Spondyloarthritis during 3 Years of Continuous Etanercept Treatment. J Rheumatol. 2016 Mar;43(3):618-24. doi: 10.3899/jrheum.150659. Epub 2016 Feb 1.

    PubMed 26834218

Questions about this trial

What is this clinical trial studying?

An observational study of Spondyloarthritis (SpA) and Whole-body MRI (WBMRI), run by The First Affiliated Hospital with Nanjing Medical University 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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 17 Nov 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Wenfeng Tan, Dr (+8618061202878, tw2006@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WB-MRI imaging characteristics of patients with axSpA. (time frame: Two years). 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 NCT07230327, which also lists 12 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 17 Nov 2025.

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