Chinese Rheumatism Biobank(CRB)

Launched by CHINESE SLE TREATMENT AND RESEARCH GROUP · Mar 19, 2025

Keywords

ClinConnect Summary

The Chinese Rheumatism Biobank (CRB) is a clinical trial focused on understanding how systemic lupus erythematosus (SLE) progresses and how we can predict major organ damage in patients with this condition. The goal is to closely monitor patients with SLE for changes in their health before and after any severe organ issues arise. This research aims to identify patterns that can help doctors better manage the disease and improve patient outcomes.

To participate in this trial, individuals must have been diagnosed with SLE within the last two years and meet specific criteria indicating their disease is currently stable and not threatening any organs. This means participants should not have serious complications affecting their kidneys, heart, or brain. If eligible, participants can expect to undergo regular evaluations and monitoring as part of the study, which will help researchers gather valuable information about the disease. It's important to note that those who are pregnant or have other serious health issues may not qualify for this trial.

Gender

ALL

Eligibility 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