Chinese Rheumatism Biobank(CRB)
Recruiting · NCT06887517 · Observational (researchers observe without assigning treatment) · Lead sponsor: Chinese SLE Treatment And Research Group
View the official record on ClinicalTrials.gov →Interventions studied
Antimalarial with or without oral glucocorticosteroid
What this trial is about
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.
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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
1 location listed.
- Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College - Beijing, Beijing Municipality, China