Tracking organ damage in lupus patients
Chinese Rheumatism Biobank(CRB)
Chinese SLE Treatment And Research Group · NCT06887517
This study is trying to see if tracking changes in lupus patients can help predict serious organ damage, especially in the kidneys and lungs, while they are treated with certain medications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | Chinese SLE Treatment And Research Group (other) |
| Drugs / interventions | belimumab, cyclophosphamide |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06887517 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with systemic lupus erythematosus within the last two years who do not have organ-threatening disease.
Not a fit: Patients with significant organ damage, such as lupus nephritis or pulmonary arterial hypertension, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and management of organ damage in lupus patients, enhancing their quality of life.
How similar studies have performed: Previous studies have shown some success in developing predictive models for organ involvement in SLE, indicating that this approach has been explored but may still hold novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality
- 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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lupus Erythematosus, Systemic, systemic lupus erythematosus, major organ damage, progress of disease