Systemic Lupus ErthematosusNCT07188285
Mass Spectrometry-based Immune Profiling in Autoimmune Diseases
An observational study of Systemic Lupus Erthematosus and Sjogren's Syndrome, run by Peking University People's Hospital at 1 site in China.
Trial summary
Based on mass spectrometry flow method, this study analyzed the typing of new T, B, NK and DC cell subsets in peripheral blood of common autoimmune diseases and their correlation with disease activity, aiming at establishing an early screening and diagnosis model of autoimmune diseases. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erthematosus, Sjogren's Syndrome, Inflammatory Myopathies
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2025to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients are in a state of disease activity and do not use biological agents.
Who may be able to join
- Male or female, and aged 18-70 at the time of screening interview (inclusive).
- The diagnosis of each disease meets the following standards - Systemic lupus erythematosus: 1997 ACR lupus classification standard
- Behcet's disease: 2014 ICBD Behcet's disease classification standard
- ANCA-associated vasculitis: 1990 American College of Rheumatology Classification Standard
- Rheumatoid arthritis: 1987 ARA classification standard
- Ankylosing spondylitis: new york standard revised in 1984
Show all 14Show fewer
- Sjogren's syndrome: 2016 ACR/EULAR Sjogren's syndrome classification standard
- Inflammatory myopathy: Bohan recommended criteria in 1977
- Systemic sclerosis: SSc standard formulated by American Rheumatology Association in 1980.
- Psoriatic arthritis: CASPAR standard in 2006
- Gouty arthritis: 1997 ACR gout classification standard
- Disease activity status, each disease should meet the disease activity index;
- Glucocorticoid (≤1mg/kg/d prednisone or other hormones with equivalent dose) was used before joining the group, and DMARDs (such as methotrexate, hydroxychloroquine, azathioprine, mycophenolate mofetil, leflunomide, cyclosporine, etc.) were allowed;
- When participating in the trial, the patient must be informed in writing and hope that the patient can abide by the requirements of the research follow-up plan and other protocols.
Who cannot join
- 1. Use IVIg or cyclophosphamide within 1.2 months, use other biological agents (infliximab, adalimumab, etanercept, anakinra, etc.) within 3 months, and use rituximab within 6 months; 2.1 months after receiving high-dose glucocorticoid (> 1 mg/kg/d). 3. Serious complications: including heart failure (≥ NYHA III), renal insufficiency (creatinine clearance rate ≤30 ml/min) and hepatic insufficiency (serum ALT or AST is greater than three times the normal upper limit, or total bilirubin is greater than the normal upper limit).
- 4. Other serious, progressive or uncontrollable hematological, gastrointestinal, endocrine, lung, heart, nerve or brain diseases (including demyelinating diseases, such as multiple sclerosis).
- 5. Suffering from serious infection (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, EB virus, tuberculosis infection), or being hospitalized due to infection, or using intravenous antibiotics to treat infection 2 months before the first dose of treatment.
- 6. Chest imaging showed abnormalities of malignant tumor or current active infection (including tuberculosis) within 3 months before enrollment.
- 7. Infected with HIV(HIV antibody positive serology) or hepatitis C (Hep C antibody positive serology). If the serum is positive, it is recommended to consult a doctor with expertise in treating HIV or hepatitis C virus infection.
- 8. Any known malignant tumor or history of malignant tumor in the past 5 years. 9. Received any vaccination within 3 months before joining the group.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking university people's hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: Mass Spectrometry-based Immune Profiling in Peripheral Blood of Autoimmune Diseases
Based on mass spectrometry flow method, this study analyzed the typing of new T, B, NK and DC cell subsets in peripheral blood of common autoimmune diseases and their correlation with disease activity, aiming at establishing an early screening and diagnosis model of autoimmune diseases.
Read the detailed description
The study will include patients with systemic lupus erythematosus, Sjogren's syndrome, inflammatory myopathy, systemic sclerosis, vasculitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, osteoarthritis and gouty arthritis and healthy controls. About 50 patients of each type are required. The patients are in a state of disease activity and do not use biological agents. Their peripheral blood will be detected by mass spectrometry.
- Conditions
- Systemic Lupus Erthematosus, Sjogren's Syndrome, Inflammatory Myopathies, Systemic Sclerosis (SSc), Vasculitis, Rheumatoid Arthritis (RA)
- Keywords
- autoimmune diseases, mass spectrometry
- Medical subject headings
- Myositis, Scleroderma, Systemic, Vasculitis, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Osteoarthritis, Arthritis, Gouty, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The patients with active autoimmune diseases | The study will include patients with systemic lupus erythematosus, Sjogren's syndrome, inflammatory myopathy, systemic sclerosis, vasculitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, osteoarthritis and gouty arthritis and healthy controls. About 50 patients of each type are required. The patients are in a state of disease activity and do not use biological agents. |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of immune cell subsets in peripheral blood.
Immune cell subsets include T cell, B cell, NK cell, Treg cell, Tfh cell, CLA+Treg cell, Tfr cell, Th1 cell, Th2 cell, Th17 cell and some unnamed cell subsets.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start25 May 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErthematosusStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China, Zhejiang PuLuoTing Health Technology Co., Ltd.
- Responsible party
- Principal investigator, He Jing, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188285
- Sponsor's protocol ID
- Immune profiling in AIDs
- Status last verified
- Aug 2026
- First submitted
- 14 Apr 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- 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 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mass Spectrometry-based Immune Profiling in Peripheral Blood of Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT07188285
- Acronym / sponsor ID
- Immune profiling in AIDs
- Conditions
- Systemic Lupus Erthematosus, Sjogren's Syndrome, Inflammatory Myopathies, Systemic Sclerosis (SSc), Vasculitis, Rheumatoid Arthritis (RA)
- Keywords
- autoimmune diseases, mass spectrometry
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China, Zhejiang PuLuoTing Health Technology Co., Ltd.
- Study start
- 25 May 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 23 Sep 2025 (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.
Based on mass spectrometry flow method, this study analyzed the typing of new T, B, NK and DC cell subsets in peripheral blood of common autoimmune diseases and their correlation with disease activity, aiming at establishing an early screening and diagnosis model of autoimmune diseases.
Detailed description
The study will include patients with systemic lupus erythematosus, Sjogren's syndrome, inflammatory myopathy, systemic sclerosis, vasculitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, osteoarthritis and gouty arthritis and healthy controls. About 50 patients of each type are required. The patients are in a state of disease activity and do not use biological agents. Their peripheral blood will be detected by mass spectrometry.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The patients with active autoimmune diseases | – | –The study will include patients with systemic lupus erythematosus, Sjogren's syndrome, inflammatory myopathy, systemic sclerosis, vasculitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, osteoarthritis and gouty arthritis and healthy controls. About 50 patients of each type are required. The patients are in a state of disease activity and do not use biological agents. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients are in a state of disease activity and do not use biological agents.
Key inclusion criteria (14 listed)
- Male or female, and aged 18-70 at the time of screening interview (inclusive).
- The diagnosis of each disease meets the following standards - Systemic lupus erythematosus: 1997 ACR lupus classification standard
- Disease activity status, each disease should meet the disease activity index;
- Glucocorticoid (≤1mg/kg/d prednisone or other hormones with equivalent dose) was used before joining the group, and DMARDs (such as methotrexate, hydroxychloroquine, azathioprine, mycophenolate mofetil, leflunomide, cyclosporine, etc.) were allowed;
- When participating in the trial, the patient must be informed in writing and hope that the patient can abide by the requirements of the research follow-up plan and other protocols.
Key exclusion criteria (6 listed)
- 1. Use IVIg or cyclophosphamide within 1.2 months, use other biological agents (infliximab, adalimumab, etanercept, anakinra, etc.) within 3 months, and use rituximab within 6 months; 2.1 months after receiving high-dose glucocorticoid (> 1 mg/kg/d). 3. Serious complications: including heart failure (≥ NYHA III), renal insufficiency (creatinine clearance rate ≤30 ml/min) and hepatic insufficiency (serum ALT or AST is greater than three times the normal upper limit, or total bilirubin is greater than the normal upper limit).
- 4. Other serious, progressive or uncontrollable hematological, gastrointestinal, endocrine, lung, heart, nerve or brain diseases (including demyelinating diseases, such as multiple sclerosis).
- 5. Suffering from serious infection (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, EB virus, tuberculosis infection), or being hospitalized due to infection, or using intravenous antibiotics to treat infection 2 months before the first dose of treatment.
- 6. Chest imaging showed abnormalities of malignant tumor or current active infection (including tuberculosis) within 3 months before enrollment.
- 7. Infected with HIV(HIV antibody positive serology) or hepatitis C (Hep C antibody positive serology). If the serum is positive, it is recommended to consult a doctor with expertise in treating HIV or hepatitis C virus infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
proportion of immune cell subsets in peripheral blood.
Time frame: through study completion, an average of 1 year
Immune cell subsets include T cell, B cell, NK cell, Treg cell, Tfh cell, CLA+Treg cell, Tfr cell, Th1 cell, Th2 cell, Th17 cell and some unnamed cell subsets.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- 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.
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 Systemic Lupus Erthematosus and Sjogren's Syndrome, run by Peking University People's Hospital 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 14 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: enrolling by invitation, as of the sponsor's last update on 26 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
proportion of immune cell subsets in peripheral blood. (time frame: through study completion, an average of 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 26 Aug 2026.