Status:
RECRUITING
Chinese Rheumatism Biobank(CRB)
Lead Sponsor:
Chinese SLE Treatment And Research Group
Conditions:
Lupus Erythematosus, Systemic
Eligibility:
All Genders
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...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 10 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2033
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06887517
Start Date
February 10 2025
End Date
April 1 2033
Last Update
April 9 2025
Active Locations (1)
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1
Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
Beijing, Beijing Municipality, China, 100730