Recruiting
Chinese Rheumatism Biobank(CRB)
Condition(s) studied
Lupus Erythematosus, Systemic
Investigational drug(s) / intervention(s)
Antimalarial with or without oral glucocorticosteroid
Antimalarial with or without oral glucocorticosteroid: 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
Study 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 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
Primary outcome measure(s)
- Occurrence of major organ involvement in SLE — From enrollment to the end of 60 months
Occurrence of lupus nephritis, immune thrombocytopenia or pulmonary arterial hypertension.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College |
Beijing |
Beijing Municipality |
Recruiting |