Phase
Condition
Lupus
Collagen Vascular Diseases
Systemic Lupus Erythematosus
Treatment
Antimalarial with or without oral glucocorticosteroid
Clinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients meet the 2012 SLICC classification criteria or 2019 ACR/EULARclassification criteria of SLE.
Disease Duration ≤2 years since SLE diagnosis at baseline
Non-Organ-Threatening Disease, including BILAG-2004 categories A/B/C inneurological, cardiopulmonary, gastrointestinal, ophthalmic, renal, or hematologicaldomains Specifically excluded: Renal: Cellular casts, hematuria (>5 RBC/hpf), proteinuria (>0.5g/24hr), pyuria (>5WBC/hpf), or biopsy-proven lupus nephritis Neuropsychiatric: Seizures, psychosis,organic brain syndrome, cerebrovascular events Cardiopulmonary: Pulmonary arterialhypertension, myocarditis, pulmonary hemorrhage Vasculitis: Ulcerative/necrotizinglesions 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 CD20inhibitors within 6 months
Disease Activity: Clinical SLEDAI-2K >0 at screening/baseline
Exclusion
Exclusion Criteria:
SLE with coexisting other autoimmune or autoinflammatory diseases, including but notlimited to rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, orpsoriasis.
SLE with concurrent conditions requiring glucocorticoid therapy, such as asthma orCrohn's disease.
Pregnancy, planned pregnancy, or lactation.
SLE with major organ dysfunction at baseline , including: impaired consciousness orcognitive 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 posesignificant risks
Study Design
Study Description
Connect with a study center
Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
Beijing, Beijing 100730
ChinaActive - Recruiting

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