Integral Single-cell Landscape of Immunological Hallmarks for Ankylosing Spondylitis

NCT06846021 | Completed DMC

• 1 other identifier: K2022-09-055
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

• 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

  8 months

Study Arms (1)

The investigators performed single-cell RNA sequencing based on PBMCs

EXPERIMENTAL

Other: Disease status

Interventions

Disease status OTHER

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

The investigators performed single-cell RNA sequencing based on PBMCs

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of ankylosing spondylitis Clinical hallmarks and imaging evidences

You may not qualify if:

• Pregnant patients Other diseases, tumors and injuries

Sponsors & Collaborators

• Fujian Provincial Hospital: lead

Study Sites (1)

Orthopedic Outpatient Room

Fuzhou, China

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 25, 2025
• Study Start: May 17, 2021
• Primary Completion: June 30, 2021
• Study Completion: August 25, 2021
• Last Updated: March 4, 2025

Record last verified: 2025-02

Locations

CN (1)