NCT06887517Recruiting
Chinese Rheumatism Biobank(CRB)
Source: ClinicalTrials.gov · Last updated 9 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 13 Mar 2025
- Start date
- 10 Feb 2025
- Primary completion date
- 1 Apr 2028
- Lead sponsor
- Chinese SLE Treatment And Research Group
- Diseases
- Lupus (SLE)
- NCT number
- NCT06887517
What you commit to
- Study type: Observational
- Planned participants: 300
- From 10 Feb 2025 to the primary completion date, 1 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- SLE with concurrent conditions requiring glucocorticoid therapy, such as asthma or Crohn's disease.
Other illness
- SLE with coexisting other autoimmune or autoinflammatory diseases, including but not limited to rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis.
- 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
- Any condition deemed by investigators to compromise trial completion or pose significant risks
Other
- Pregnancy, planned pregnancy, or lactation.
- Inability to ensure compliance with long-term follow-up
Who the study is looking for
- 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
- 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
- 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
- Disease Activity: Clinical SLEDAI-2K \>0 at screening/baseline
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.