Chinese Rheumatism Biobank(CRB)

NCT06887517 | Recruiting

• 1 other identifier: CSTAR010
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Lupus Erythematosus, Systemic

Keywords

systemic lupus erythematosus; major organ damage; progress of disease

Outcome Measures

Primary Outcomes (1)

• Occurrence of major organ involvement in SLE

  Occurrence of lupus nephritis, immune thrombocytopenia or pulmonary arterial hypertension.

  From enrollment to the end of 60 months

Secondary Outcomes (2)

• Occurrence of disease activity within 24 weeks

  From enrollment to the end of 24 weeks

• Failure to meet DORIS remission criteria at the end of 24 weeks

  From enrollment to the end of 24 weeks.

Interventions

Antimalarial with or without oral glucocorticosteroid DRUG

Intervention one: Antimalarial and Oral Glucocorticosteroid, Prednisone or equivalent dose of glucocorticoid tapering: 0.5\~0.6mg/kg/d(week 0\~2), 0.3\~0.4mg/kg/d(week 3\~4), 15 mg/d(week 5\~6), 10 mg/d(week 7\~8), 7.5 mg /d(week 9\~10), 5 mg/d(week 11\~12), 2.5 mg/d(week 13\~24), \<2.5 mg/d(after week 24)；Hydroxychloroquin 6.5mg/kg/d but no more than 400mg/d for initial therapy, and reduce to 4\~5mg/kg/d for maintenance therapy Intervention two: Antimalarial only. Hydroxychloroquin 6.5mg/kg/d but no more than 400mg/d for initial therapy, and reduce to 4\~5mg/kg/d for maintenance therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with systemic lupus erythematosus (SLE) at Peking Union Medical College Hospital, who met the inclusion/exclusion criteria and voluntarily provided written informed consent.

You may qualify if:

• 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

You may not qualify if:

• SLE with coexisting other autoimmune or autoinflammatory diseases, including but not limited to rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis.
• SLE with concurrent conditions requiring glucocorticoid therapy, such as asthma or Crohn's disease.
• Pregnancy, planned pregnancy, or lactation.
• 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
• Inability to ensure compliance with long-term follow-up
• Any condition deemed by investigators to compromise trial completion or pose significant risks

Sponsors & Collaborators

• Chinese SLE Treatment And Research Group: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1. Blood samples , from which DNA, RNA, serum, plasma, cfRNA, cfDNA, PBMC are isolated； 2. Nasopharyngeal swab

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Antimalarials

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antiprotozoal Agents; Antiparasitic Agents; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 20, 2025
• Study Start: February 10, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2033
• Last Updated: April 9, 2025

Record last verified: 2025-03

Locations

CN (1)