Chinese Rheumatism Biobank(CRB)

Recruiting now

Conditions studied: Lupus Erythematosus, Systemic

In brief

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.

Key facts

Study ID

NCT06887517

Run by

Chinese SLE Treatment And Research Group

People needed

300

Starts

2025-02-10

Expected to finish

2033-04-01

Last updated by the study team

2025-04-09

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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