| NCT ID | NCT06887517 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese SLE Treatment And Research Group |
| Condition | Lupus Erythematosus, Systemic |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-02-10 |
| Primary Completion | 2028-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-02-10 with a primary completion date of 2028-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Patients meet the 2012 SLICC classification criteria or 2019 ACR/EULAR classification criteria of SLE. 2. Disease Duration ≤2 years since SLE diagnosis at baseline 3. 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 4. 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 5. Disease Activity: Clinical SLEDAI-2K \>0 at screening/baseline Exclusion Criteria: 1. SLE with coexisting other autoimmune or autoinflammatory diseases, including but not limited to rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis. 2. SLE with concurrent conditions requiring glucocorticoid therapy, such as asthma or Crohn's disease. 3. Pregnancy, planned pregnancy, or lactation. 4. 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 5. Inability to ensure compliance with long-term follow-up 6. Any condition deemed by investigators to compromise trial completion or pose significant risks
Frequently Asked Questions
Who can join the NCT06887517 clinical trial?
This trial is open to participants of all sexes, studying Lupus Erythematosus, Systemic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06887517 currently recruiting?
Yes, NCT06887517 is actively recruiting participants. Visit ClinicalTrials.gov or contact Chinese SLE Treatment And Research Group to inquire about joining.
Where is the NCT06887517 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06887517 clinical trial?
NCT06887517 is sponsored by Chinese SLE Treatment And Research Group. The trial plans to enroll 300 participants.
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