Chinese Rheumatism Biobank(CRB)
Chinese SLE Treatment And Research Group
300 participants
Feb 10, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria6
- 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
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Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06887517