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

November 14, 2025 updated by: Wenfeng Tan, The First Affiliated Hospital with Nanjing Medical University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • the First Affiliated Hospital of Nanjing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Exclusion Criteria:

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

And diagnosed with non-radiographic or radiographic axial SpA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WB-MRI imaging characteristics of patients with axSpA.
Time Frame: Two years
Compare the correlation between WB-MRI changes and disease activity, disease progression and structural damage at baseline and after 2 years of follow-up.
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The correlation between WB-MRI changes and disease activities
Time Frame: Five yeas
To elucidate the correlation between WB-MRI changes and inflammation, structural damage and disease activity in patients with axSpA.
Five yeas

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 15, 2024

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPA-JS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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