Chinese Rheumatism Biobank(CRB)
ConditionLupus Erythematosus, Systemic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorChinese SLE Treatment And Research Group
About this trial
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 criteria
Qualifiers
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
Disease Activity: Clinical SLEDAI-2K >0 at screening/baseline
Disqualifiers
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
Trial design
Treatments tested in this trial
- Antimalarial with or without oral glucocorticosteroid
Treatment groups
No treatment groups listed
Locations
1Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College100730, BeijingBeijing Municipality, China
Sponsors and collaborators
Chinese SLE Treatment And Research Group
Lead sponsor
Source ClinicalTrials.gov