banner-field

Solutions

Clinical Trials of Systemic Lupus Erythematosus - Laboratory Solutions


Systemic lupus erythematosus (SLE) is a systemic autoimmune disease characterized by the involvement of multiple systems and organs, recurrent relapses and remission, and the presence of a large number of autoantibodies. If not treated in time, it will cause irreversible damage to the affected organs, ultimately leading to patient death.

In China, the disease burden of SLE ranks first in the world, with a total patient population of approximately 1 million, and about 120,000 new confirmed cases annually. The traditional treatment of SLE primarily involves broad-spectrum anti-inflammatory and immunosuppressive drugs,, including antimalarial drugs, glucocorticoids, and immunosuppressants.  Biologics have provided new treatment options for SLE.

KingMylab has supported over 50 clinical trial projects in the field of immune diseases. The laboratory technology platform is comprehensive, providing full support for clinical research of immune diseases, including patient screening, stratification, pharmacodynamics, and safety indicators.


Inclusion/Exclusion and Stratification
Inclusion/Exclusion and Stratification


Primary Markers

ANA, Anti-dsDNA Antibody, Anti-Smith Antibody, Anti-phospholipid Antibody, Anti-RNP Antibody, Anti-SS-A Antibody, Anti-SS-B Antibody, C3, C4, CH50, Coombs, etc.


Other Inclusion/Exclusion Markers

Complete Blood Count (CBC), Blood Biochemistry, Urine Protein, UPCR, HIV, HBV, HCV, EBV, CMV, VZV, TB, etc.


PD Markers
PD Markers


SLEDAI-2K-associated Markers

C3, C4, CH50, Anti-dsDNA Antibody, UPCR


BILAG-2004-associated Indicators

Anti-cardiolipin Antibody, Lupus Anticoagulant, Binding Globin, Coombs


Other Immune Markers

IgG, IgA, IgM, IgE, Peripheral Blood B Cell Subsets, etc.


Inflammation and Cytokines

IL-6, IFN-γ, etc.


Other Markers

Drug-based MOA


Safety Markers
Safety Markers

Complete Blood Count

RBC, WBC, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Hemoglobin, Hematocrit, Platelets, etc.


Blood Biochemistry

Blood Sodium, Potassium, Calcium (total and albumin-corrected), ALP, ALT, AST, Total Bilirubin, Direct Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Uric Acid, Creatine Kinase, LDH, Albumin, Blood Glucose,Calcitonin, Lipase, Amylase, CRP, etc.


Blood Coagulation

PT, aPTT, INR, PAI-1, Fibrinogen, etc.


Urinalysis Test
Urinary Biochemistry (albumin, creatinine, urine sugar, ketone bodies,etc.), Microscopy, Urinary hCG