Tracking organ damage in lupus patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to predict major organ damage in patients with systemic lupus erythematosus (SLE) by dynamically monitoring their condition before and after the onset of such damage. It focuses on understanding the microscopic molecular changes that correlate with the macroscopic clinical manifestations of the disease. The study will analyze various demographic, clinical, and laboratory indicators to develop predictive models for organ involvement, particularly targeting lupus nephritis and pulmonary arterial hypertension. Patients will be treated with antimalarial medications, with or without oral glucocorticosteroids, to assess their impact on disease progression.

Why it matters

Who can join: the full rules

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

Where it's running

• Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
  Beijing, Beijing Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.