Multi-omics Study and Drug Intervention Study of Spondyloarthritis

NCT05494203 | Unknown

• 1 other identifier: XiaobingWang
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Spondylarthritis

Outcome Measures

Primary Outcomes (1)

• Long-term outcomes after treatment

  disease activity

  1 year

Study Arms (2)

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

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.

Interventions

questionnaire survey DIAGNOSTIC_TEST

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

spa

Eligibility Criteria

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

Study Population

community sample

You may qualify if:

• The patient meets the revised AS New York diagnostic criteria or ASAS axial SpA classification criteria.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

Xiaobing Wang

Wenzhou, Zhejiang, 325000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, urine, fecal sample, saliva, Plaque

MeSH Terms

Conditions

Spondylarthritis

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Principal Investigator

Study Record Dates

• First Submitted: August 6, 2022
• First Posted: August 9, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: July 1, 2023
• Last Updated: August 12, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)