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Study on the characteristics of important organ injury and new intervention strategies in the elderly with AID

Study on the characteristics of important organ injury and new intervention strategies in the elderly with AID

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200066477
Enrollment
Unknown
Registered
2022-12-06
Start date
2022-12-15
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly autoimmune diseases

Interventions

SLE subjects:N/A
RA subjects:N/A
SV subjects:N/A
Healthy control group:N/A

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1)Age: 18-65 years, patients with SLE or RA; (2)The diagnosis of SLE patients should meet the 1987 revised American College of Rheumatology classification criteria; disease activity was assessed using the systemic lupus erythematosus disease activity index (SLEDAI) scoring system; SLEDA score >= 5 , ANA antibody >= 1:40; hormone maintenance dose 28 mm/h; methotrexate or methotrexate + leflunomide treatment was ineffective for 3 months, and no other anti-rheumatic drugs (available low-dose hormones ± NSAIDs) were used in the last 3 months; (4)All patients have not been treated with glucocorticoids, immunosuppressants, disease-modifying antirheumatic drugs or biologics within 6 months; (5) The healthy control population should be sex- and age-matched to SLE or RA patients, and the enrolled population should have no history of SLE, RA or other AIDs.

Exclusion criteria

Exclusion criteria: (1)Patients or healthy controls taking antibiotics, anticonvulsant medications or suffering from gastrointestinal-type colds that affect the intestinal flora in the last month; (2)Patients or healthy controls with recent serious underlying diseases such as infectious diseases, malignancies, leukemia, acute heart failure, acute coronary syndrome; (3)Patients with signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, psychiatric or cerebral diseases; (4)Patients who have undergone organ transplantation.

Design outcomes

Primary

MeasureTime frame
lymphocyte subsets;Blood ELISA cytokine levels;PBMC Immune Cell Types;Types of PBMC immune cells;Peripheral blood proteomics;Peripheral Blood RNA Sequencing;Peripheral blood single cell sequencing;Renal tissue proteomics;RNA sequencing of kidney tissue;Single cell sequencing of kidney tissue;Joint cavity synovial fluid routine;Synovial fluid biochemistry of joint cavity;Inflammatory index of synovial fluid;Joint cavity synovial proteomics;Joint synovial RNA sequencing;Single cell sequencing of synovial joint cavity;Skin tissue proteomics;Skin tissue RNA sequencing;Single Cell Sequencing of Skin Tissue;Blood routine test;Blood biochemical test;Routine detection of feces;Routine urine test;Vasculitis screening test;Immunoglobulin;24h urine protein;Inflammatory markers;C3?C4;

Secondary

MeasureTime frame
Antinuclear antibodies spectrum;Autoantibodies;Coagulation function;Joint imaging examination;Renal ultrasonography;

Countries

China

Contacts

Public ContactPing Li

Chinese PLA General Hospital

liping@301hospital.com.cn+86 15810136659

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026