Lupus Erythematosus, SystemicNCT06887517
Chinese Rheumatism Biobank(CRB)
An observational study of Lupus Erythematosus, Systemic, run by Chinese SLE Treatment And Research Group at 1 site in China.
Trial summary
Early prediction of major organ damage in SLE needs to dynamically track the evolution of SLE patients before and after the onset of major organ damage, and analyze the microscopic molecular evolution patterns synchronized with the macroscopic pathophysiological changes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- Antimalarial with or without oral glucocorticosteroid
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2025to 1 Apr 2033
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with systemic lupus erythematosus (SLE) at Peking Union Medical College Hospital, who met the inclusion/exclusion criteria and voluntarily provided written informed consent.
Who may be able to join
- Patients meet the 2012 SLICC classification criteria or 2019 ACR/EULAR classification criteria of SLE.
- Disease Duration ≤2 years since SLE diagnosis at baseline
- Non-Organ-Threatening Disease, including BILAG-2004 categories A/B/C in neurological, cardiopulmonary, gastrointestinal, ophthalmic, renal, or hematological domains
- Specifically excluded:
- Renal: Cellular casts, hematuria (>5 RBC/hpf), proteinuria (>0.5g/24hr), pyuria (>5 WBC/hpf), or biopsy-proven lupus nephritis Neuropsychiatric: Seizures, psychosis, organic brain syndrome, cerebrovascular events Cardiopulmonary: Pulmonary arterial hypertension, myocarditis, pulmonary hemorrhage Vasculitis: Ulcerative/necrotizing lesions or biopsy-proven vasculitis Hematologic: Hemolytic anemia, thrombocytopenia (<100×10⁹/L) No acute thromboembolic events within 3 months
- Treatment History:
- No systemic corticosteroids, plasmapheresis, or IVIG within 3 months No biologics (e.g. belimumab, TNF-α inhibitors) within 3 months No cyclophosphamide or CD20 inhibitors within 6 months
- Disease Activity: Clinical SLEDAI-2K >0 at screening/baseline
Who cannot join
- SLE with coexisting other autoimmune or autoinflammatory diseases, including but not limited to rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis.
- SLE with concurrent conditions requiring glucocorticoid therapy, such as asthma or Crohn's disease.
- Pregnancy, planned pregnancy, or lactation.
- SLE with major organ dysfunction at baseline , including: impaired consciousness or cognitive decline, renal insufficiency, cardiac insufficiency (NYHA Class 3 or 4), pulmonary hypertension or interstitial lung disease, uncontrolled infections
- Inability to ensure compliance with long-term follow-up
- Any condition deemed by investigators to compromise trial completion or pose significant risks
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, 1 recruiting
- Recruiting
Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
Beijing, Beijing Municipality, 100730
Mengtao Li, +86-13911788572, mengtao.li@cstar.org.cn
About this study
Early prediction of major organ damage in SLE needs to dynamically track the evolution of SLE patients before and after the onset of major organ damage, and analyze the microscopic molecular evolution patterns synchronized with the macroscopic pathophysiological changes.
Read the detailed description
Systemic lupus erythematosus (SLE) is a complex autoimmune disease characterized by the presence of multiple autoantibodies in the serum and multisystemic damage.The clinical manifestations of SLE are highly heterogeneous, and damage to different organs appears gradually over time. Lupus nephritis (LN) and thrombocytopenia (TP) represent the most common major organ damage in SLE, with an incidence of about 30-40%; pulmonary arterial hypertension (PAH) is a rare but difficult complication of SLE. Pulmonary arterial hypertension (PAH) is a rare but intractable complication of SLE, which clinically manifests itself as a progressively worsening increase in pulmonary arterial pressure, and ultimately causes right heart failure or even death. Once combined with LN, TP, PAH and other important organ damage, the long-term prognosis and quality of life of SLE patients are severely impaired.
Some predictive models for the occurrence of organ involvement in SLE have been reported in previous studies. Among them, several incidence prediction models for lupus nephritis (LN) included demographic, clinical and laboratory indicators such as male, anti-dsDNA antibody positivity, age and duration of SLE onset, erythrocyte sedimentation rate, mucosal ulceration, proteinuria, hematuria, etc., with the area under the curve (AUC) of the prediction model of 0.707. A prediction model for incidence prediction of neuropsychiatric lupus (NPSLE) incorporated both patient disease and environmental indicators, including anti-dsDNA antibody positivity, anti-SSA antibody positivity, lymphocyte count, erythrocyte pressure volume, erythrocyte sedimentation rate, prealbumin, retinol-binding protein, creatine kinase isoenzyme MB, brain natriuretic peptide precursor, creatinine, indirect bilirubin, fibrinogen, ultrasensitive C-reactive protein, CO, and mild contamination, which had an AUC in the discovery and validation cohorts of up to 0.849-0.895. Our center team has developed 2 predictive models for the onset of SLE organ involvement: the SLE-associated pulmonary arterial hypertension (PAH) onset prediction model contains 5 clinical variables (acute/subacute cutaneous lupus, arthritis, renal involvement, thrombocytopenia, and interstitial lung disease) and 3 autoantibodies (anti-RNP antibody positivity, anti-Ro/SSA antibody positivity, and anti-La/SSB antibody positivity). La/SSB antibody positive). The above predictive models for the occurrence of SLE organ involvement basically used easily accessible clinical data, such as clinical manifestations and laboratory indicators, and the models were practical; however, most of the models were not constructed based on prospective cohorts, and some of the models were not validated in large-scale patient populations, so the predictive efficacy of the models is still unsatisfactory, and their clinical application is still difficult.
There is still a lack of effective biomarkers and prediction models for important organ damage in SLE. The fundamental problem is that there is no high-quality cohort of SLE patients before and after the onset of organ damage. Therefore, early prediction of vital organ damage in SLE can only be achieved by dynamically tracking the evolution of SLE patients before and after the onset of vital organ damage, and analyzing the microscopic molecular evolution patterns synchronized with the macroscopic pathophysiological changes.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- Antimalarial with or without oral glucocorticosteroid
- Keywords
- systemic lupus erythematosus, major organ damage, progress of disease
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antimalarial with or without oral glucocorticosteroidDrug
Intervention one: Antimalarial and Oral Glucocorticosteroid, Prednisone or equivalent dose of glucocorticoid tapering: 0.5~0.6mg/kg/d(week 0~2), 0.3~0.4mg/kg/d(week 3~4), 15 mg/d(week 5~6), 10 mg/d(week 7~8), 7.5 mg /d(week 9~10), 5 mg/d(week 11~12), 2.5 mg/d(week 13~24), <2.5 mg/d(after week 24);Hydroxychloroquin 6.5mg/kg/d but no more than 400mg/d for initial therapy, and reduce to 4~5mg/kg/d for maintenance therapy
Intervention two: Antimalarial only. Hydroxychloroquin 6.5mg/kg/d but no more than 400mg/d for initial therapy, and reduce to 4~5mg/kg/d for maintenance therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of major organ involvement in SLE
Occurrence of lupus nephritis, immune thrombocytopenia or pulmonary arterial hypertension.
Measured: From enrollment to the end of 60 months
Secondary outcomes (2)
Occurrence of disease activity within 24 weeks
Disease activity was defined as the presence of fever, alopecia, rash, arthritis, mucosal ulcers, myositis, pleurisy, pericarditis, decreased complement levels, or increased anti-ds-DNA antibody levels, etc.
Measured: From enrollment to the end of 24 weeks
Failure to meet DORIS remission criteria at the end of 24 weeks
DORIS stands for Definitions of remission in systemic lupus erythematosus. Clinical remission was defined as:
- cSLEDAI (SLEDAI-2K Clinical Indicator) = 0 (except for low complement and anti-dsDNA positivity)
- PGA <0.5 points
- No oral glucocorticoids
- Immunosuppressants (except CTX) and biologics are stable, antimalarials are available
Measured: From enrollment to the end of 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start10 Feb 2025
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese SLE Treatment And Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887517
- Sponsor's protocol ID
- CSTAR010
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Rheumatism Biobank(CRB)
- ClinicalTrials.gov ID
- NCT06887517
- Acronym / sponsor ID
- CSTAR010
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- systemic lupus erythematosus, major organ damage, progress of disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chinese SLE Treatment And Research GroupUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2033 (estimated)
- First posted
- 20 Mar 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.
Early prediction of major organ damage in SLE needs to dynamically track the evolution of SLE patients before and after the onset of major organ damage, and analyze the microscopic molecular evolution patterns synchronized with the macroscopic pathophysiological changes.
Detailed description
Systemic lupus erythematosus (SLE) is a complex autoimmune disease characterized by the presence of multiple autoantibodies in the serum and multisystemic damage.The clinical manifestations of SLE are highly heterogeneous, and damage to different organs appears gradually over time. Lupus nephritis (LN) and thrombocytopenia (TP) represent the most common major organ damage in SLE, with an incidence of about 30-40%; pulmonary arterial hypertension (PAH) is a rare but difficult complication of SLE. Pulmonary arterial hypertension (PAH) is a rare but intractable complication of SLE, which clinically manifests itself as a progressively worsening increase in pulmonary arterial pressure, and ultimately causes right heart failure or even death. Once combined with LN, TP, PAH and other important organ damage, the long-term prognosis and quality of life of SLE patients are severely impaired.
Some predictive models for the occurrence of organ involvement in SLE have been reported in previous studies. Among them, several incidence prediction models for lupus nephritis (LN) included demographic, clinical and laboratory indicators such as male, anti-dsDNA antibody positivity, age and duration of SLE onset, erythrocyte sedimentation rate, mucosal ulceration, proteinuria, hematuria, etc., with the area under the curve (AUC) of the prediction model of 0.707. A prediction model for incidence prediction of neuropsychiatric lupus (NPSLE) incorporated both patient disease and environmental indicators, including anti-dsDNA antibody positivity, anti-SSA antibody positivity, lymphocyte count, erythrocyte pressure volume, erythrocyte sedimentation rate, prealbumin, retinol-binding protein, creatine kinase isoenzyme MB, brain natriuretic peptide precursor, creatinine, indirect bilirubin, fibrinogen, ultrasensitive C-reactive protein, CO, and mild contamination, which had an AUC in the discovery and validation cohorts of up to 0.849-0.895. Our center team has developed 2 predictive models for the onset of SLE organ involvement: the SLE-associated pulmonary arterial hypertension (PAH) onset prediction model contains 5 clinical variables (acute/subacute cutaneous lupus, arthritis, renal involvement, thrombocytopenia, and interstitial lung disease) and 3 autoantibodies (anti-RNP antibody positivity, anti-Ro/SSA antibody positivity, and anti-La/SSB antibody positivity). La/SSB antibody positive). The above predictive models for the occurrence of SLE organ involvement basically used easily accessible clinical data, such as clinical manifestations and laboratory indicators, and the models were practical; however, most of the models were not constructed based on prospective cohorts, and some of the models were not validated in large-scale patient populations, so the predictive efficacy of the models is still unsatisfactory, and their clinical application is still difficult.
There is still a lack of effective biomarkers and prediction models for important organ damage in SLE. The fundamental problem is that there is no high-quality cohort of SLE patients before and after the onset of organ damage. Therefore, early prediction of vital organ damage in SLE can only be achieved by dynamically tracking the evolution of SLE patients before and after the onset of vital organ damage, and analyzing the microscopic molecular evolution patterns synchronized with the macroscopic pathophysiological changes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with systemic lupus erythematosus (SLE) at Peking Union Medical College Hospital, who met the inclusion/exclusion criteria and voluntarily provided written informed consent.
Key inclusion criteria (8 listed)
- Patients meet the 2012 SLICC classification criteria or 2019 ACR/EULAR classification criteria of SLE.
- Disease Duration ≤2 years since SLE diagnosis at baseline
- Non-Organ-Threatening Disease, including BILAG-2004 categories A/B/C in neurological, cardiopulmonary, gastrointestinal, ophthalmic, renal, or hematological domains
- Renal: Cellular casts, hematuria (>5 RBC/hpf), proteinuria (>0.5g/24hr), pyuria (>5 WBC/hpf), or biopsy-proven lupus nephritis Neuropsychiatric: Seizures, psychosis, organic brain syndrome, cerebrovascular events Cardiopulmonary: Pulmonary arterial hypertension, myocarditis, pulmonary hemorrhage Vasculitis: Ulcerative/necrotizing lesions or biopsy-proven vasculitis Hematologic: Hemolytic anemia, thrombocytopenia (<100×10⁹/L) No acute thromboembolic events within 3 months
- Treatment History:
Key exclusion criteria (6 listed)
- SLE with coexisting other autoimmune or autoinflammatory diseases, including but not limited to rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis.
- SLE with concurrent conditions requiring glucocorticoid therapy, such as asthma or Crohn's disease.
- Pregnancy, planned pregnancy, or lactation.
- SLE with major organ dysfunction at baseline , including: impaired consciousness or cognitive decline, renal insufficiency, cardiac insufficiency (NYHA Class 3 or 4), pulmonary hypertension or interstitial lung disease, uncontrolled infections
- Inability to ensure compliance with long-term follow-up
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 |
|---|---|---|
| Antimalarial with or without oral glucocorticosteroidIntervention one: Antimalarial and Oral Glucocorticosteroid, Prednisone or equivalent dose of glucocorticoid tapering: 0.5~0.6mg/kg/d(week 0~2), 0.3~0.4mg/kg/d(week 3~4), 15 mg/d(week 5~6), 10 mg/d(week 7~8), 7.5 mg /d(week 9~10), 5 mg/d(week 11~12), 2.5 mg/d(week 13~24), <2.5 mg/d(after week 24);Hydroxychloroquin 6.5mg/kg/d but no more than 400mg/d for initial therapy, and reduce to 4~5mg/kg/d for maintenance therapy Intervention two: Antimalarial only. Hydroxychloroquin 6.5mg/kg/d but no more than 400mg/d for initial therapy, and reduce to 4~5mg/kg/d for maintenance therapy | Drug | – |
Primary outcome
Occurrence of major organ involvement in SLE
Time frame: From enrollment to the end of 60 months
Occurrence of lupus nephritis, immune thrombocytopenia or pulmonary arterial hypertension.
2 secondary outcomes
Occurrence of disease activity within 24 weeks
Time frame: From enrollment to the end of 24 weeks
Failure to meet DORIS remission criteria at the end of 24 weeks
Time frame: From enrollment to the end of 24 weeks.
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 9 Apr 2025.
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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.
Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
Beijing, China
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 Lupus Erythematosus, Systemic, run by Chinese SLE Treatment And Research Group 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 8 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: looking for participants now, as of the sponsor's last update on 9 Apr 2025. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of major organ involvement in SLE (time frame: From enrollment to the end of 60 months). 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 9 Apr 2025.