Integral Single-cell Landscape of Immunological Hallmarks for Ankylosing Spondylitis

February 27, 2025 updated by: Dianshan Ke, Fujian Provincial Hospital

Single-cell Immunomics Research on the Onset and Different Outcomes in Patients with Ankylosing Spondylitis

Three HLA-B27-positive health donors (HDs) with matching age were enrolled via genetic screening, and fourteen AS patients were recruited at Fujian provincial hospital from May to July 2021. All AS patients satisfied the modified New York (NY) criteria, and the categorization of three disease groups (EA, LD and RM) was according to clinical hallmarks and imaging evidences. The five patients in the EA group were in the early stage of disease, showing obvious symptoms, and had not yet received standard treatments, including various NSAIDs and DMARDs. The five patients in the LD group were all disabled, and confirmed by radiographic evidence of structural damage in hip joints and spinal deformity. The four patients in the RM group received standardized treatment under the guidance of specialist doctors, and maintained clinical remission and normal laboratory indicators for over six months. Patients in both EA and RM groups were confirmed to have no structural damage or deformities by radiographic evidences.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
      • Fuzhou, China
        • Orthopedic Outpatient Room

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Clinical diagnosis of ankylosing spondylitis Clinical hallmarks and imaging evidences

Exclusion Criteria:

Pregnant patients Other diseases, tumors and injuries

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

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The investigators performed single-cell RNA sequencing based on PBMCs
Other: Disease status
According to the disease status, patients are divided into four groups including healthy donors, initial patients with high activity, patients with deformities and patients with clinical remission

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of the immunological characteristics regarding the onset and outcomes of ankylosing-spondylitis patients relying on single-cell transcriptomics analysis for four groups of subjects (including health donors and patients in early active stage, l
Time Frame: 8 months
8 months

Collaborators and Investigators

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

Sponsor

Fujian Provincial Hospital

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)

May 17, 2021

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

August 25, 2021

Study Registration Dates

First Submitted

February 12, 2025

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K2022-09-055

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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