Actively Recruiting

All Genders
NCT06887517

Chinese Rheumatism Biobank(CRB)

Led by Chinese SLE Treatment And Research Group · Updated on 2025-04-09

300

Participants Needed

1

Research Sites

424 weeks

Total Duration

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AI-Summary

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.

CONDITIONS

Official Title

Chinese Rheumatism Biobank(CRB)

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients meet the 2012 SLICC or 2019 ACR/EULAR classification criteria for SLE
  • Disease duration of 2 years or less since SLE diagnosis at baseline
  • Non-organ-threatening disease with BILAG-2004 categories A/B/C in neurological, cardiopulmonary, gastrointestinal, ophthalmic, renal, or hematological domains
  • No severe kidney abnormalities such as cellular casts, significant hematuria, proteinuria, pyuria, or biopsy-proven lupus nephritis
  • No neuropsychiatric symptoms like seizures, psychosis, brain syndrome, or cerebrovascular events
  • No cardiopulmonary conditions including pulmonary arterial hypertension, myocarditis, or pulmonary hemorrhage
  • No ulcerative/necrotizing vasculitis lesions or biopsy-proven vasculitis
  • No hemolytic anemia or severe thrombocytopenia (platelets below 100×10⁹/L)
  • No acute thromboembolic events within 3 months
  • No systemic corticosteroids, plasmapheresis, IVIG, biologics, cyclophosphamide, or CD20 inhibitors within specified recent periods
  • Clinical SLEDAI-2K score greater than 0 at screening or baseline
Not Eligible

You will not qualify if you...

  • Presence of other autoimmune or autoinflammatory diseases such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis
  • Concurrent conditions requiring glucocorticoid therapy like asthma or Crohn's disease
  • Pregnancy, planned pregnancy, or lactation
  • Major organ dysfunction at baseline including impaired consciousness, cognitive decline, kidney or cardiac insufficiency, pulmonary hypertension, interstitial lung disease, or uncontrolled infections
  • Inability to comply with long-term follow-up requirements
  • Any condition that investigators consider could prevent study completion or pose significant risks

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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