Multi-omics Study and Drug Intervention Study of Spondyloarthritis

Sponsor
First Affiliated Hospital of Wenzhou Medical University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05494203
Collaborator
(none)
400
1
10
40.2

Study Details

Study Description

Brief Summary

Spondyloarthritis (SpA) is a type of chronic inflammatory rheumatic disease that mainly affects the spine and peripheral joints, or joints, ligaments and tendons. This disease subtype has the same clinical and immunological features. Further explore the pathogenesis of spondyloarthritis, explore the guiding significance of different imaging examinations for spondyloarthritis, and study the efficacy and mechanism of different drugs for spondyloarthritis.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: questionnaire survey

Detailed Description

  1. Clinical phenotype research. The clinical phenotype is the symptoms and signs of the disease and its evolution. Through the clinical phenotype research of spondyloarthritis, it is helpful to realize the diagnosis and grading of spondyloarthritis and help to achieve individualization Precise treatment.

  2. Transcriptomic research. The key genes and pathways involved in the pathogenesis of spondyloarthritis can be explored through transcriptomic research of spondyloarthritis, which can provide help for early diagnosis and seeking potential treatment methods.

  3. Microbiological research. Through the microbiome research on spondyloarthritis, the composition and function of intestinal flora in patients with spondyloarthritis can be deeply analyzed to provide help for diagnosis and treatment.

  4. Radiomics research. Through the radiomics research on spondyloarthritis, it is helpful to realize the diagnosis and grading of spondyloarthritis and the evaluation and prediction of treatment.

  5. Drug treatment research By studying the therapeutic effects of different drugs in patients with spondyloarthritis, it is helpful to explore the efficacy and mechanism of different drugs on spondyloarthritis, and to achieve precise and individualized treatment.

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Multi-omics Study and Drug Intervention Study of Spondyloarthritis
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
spa

Untreated patients meeting the revised AS New York diagnostic criteria or the ASAS classification criteria for axial SpA. Exclusion criteria: ① Patients with rheumatoid arthritis, scleroderma, systemic lupus erythematosus and other diseases of the immune system; ② Patients who have received head and neck radiation therapy; ③ Those who have a history of using antidepressants and parasympathetic stimulants; ④ Known infection with human immunodeficiency virus (HIV) or hepatitis C virus; ⑤ Patients with sarcoidosis or tuberculosis infection. According to the existing ethical approval documents, the patients signed the informed consent.

Diagnostic Test: questionnaire survey
All patients received lifestyle questionnaire, medical history, physical signs, auxiliary examination and laboratory examination results before treatment.

HC

healthy control. Exclusion criteria: ① Patients with rheumatoid arthritis, scleroderma, systemic lupus erythematosus and other diseases of the immune system; ② Patients who have received head and neck radiation therapy; ③ Those who have a history of using antidepressants and parasympathetic stimulants; ④ Known infection with human immunodeficiency virus (HIV) or hepatitis C virus; ⑤ Patients with sarcoidosis or tuberculosis infection. According to the existing ethical approval documents, the patients signed the informed consent.

Outcome Measures

Primary Outcome Measures

  1. Long-term outcomes after treatment [1 year]

    disease activity

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • The patient meets the revised AS New York diagnostic criteria or ASAS axial SpA classification criteria.
Exclusion Criteria:
  • patients with rheumatoid arthritis, scleroderma, systemic lupus erythematosus and other immune system diseases;

  • patients who had received head and neck radiotherapy;

  • patients with history of antidepressants and parasympathetic stimulants;

  • patients known to be infected with human immunodeficiency virus (HIV) or hepatitis C virus;

  • patients with sarcoidosis or tuberculosis infection.

  • patients with inflammatory bowel disease or uveitis.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xiaobing Wang Wenzhou Zhejiang China 325000

Sponsors and Collaborators

  • First Affiliated Hospital of Wenzhou Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
XiaobingWang, Clinical Professor, Principal Investigator, First Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT05494203
Other Study ID Numbers:
  • XiaobingWang
First Posted:
Aug 9, 2022
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 12, 2022