Multi-omics Study and Drug Intervention Study of Spondyloarthritis

Spondylarthritis Clinical Trial

Official title:

Multi-omics Study and Drug Intervention Study of Spondyloarthritis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05494203
• Other study ID #: XiaobingWang
• Status: Enrolling by invitation
• Start date: September 2022
• Est. completion date: July 2023

Study information

• Verified date: August 2022
• Source: First Affiliated Hospital of Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: July 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Spondylarthritis
• Spondylitis

Intervention

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

Locations

Country	Name	City	State
China	Xiaobing Wang	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term outcomes after treatment	disease activity	1 year