SpondylarthritisNCT05494203
Multi-omics Study and Drug Intervention Study of Spondyloarthritis
An observational study of Spondylarthritis, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Spondylarthritis
- What is being tested?
- questionnaire survey
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Sep 2022to Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: community sample
Who may be able to join
- The patient meets the revised AS New York diagnostic criteria or ASAS axial SpA classification criteria.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
- 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.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Spondylarthritis
- Being tested
- questionnaire survey
- Medical subject headings
- Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire surveyDiagnostic test
All patients received lifestyle questionnaire, medical history, physical signs, auxiliary examination and laboratory examination results before treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term outcomes after treatment
disease activity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study startSep 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylarthritisStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XiaobingWang, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494203
- Sponsor's protocol ID
- XiaobingWang
- Status last verified
- Aug 2022
- First submitted
- 6 Aug 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-omics Study and Drug Intervention Study of Spondyloarthritis
- ClinicalTrials.gov ID
- NCT05494203
- Acronym / sponsor ID
- XiaobingWang
- Conditions
- Spondylarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 9 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
- 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.
- 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.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spa | – | Diagnostic Test: questionnaire surveyUntreated 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- community sample
Key inclusion criteria (1 listed)
- The patient meets the revised AS New York diagnostic criteria or ASAS axial SpA classification criteria.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire surveyAll patients received lifestyle questionnaire, medical history, physical signs, auxiliary examination and laboratory examination results before treatment. | Diagnostic test | spa |
Primary outcome
Long-term outcomes after treatment
Time frame: 1 year
disease activity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondylarthritis, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term outcomes after treatment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022.