Multi-omics Studies on the Efficacy of Telitacicept in Chinese SLE Patients

Launched by FEN LI · Dec 23, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Telitacicept for patients with systemic lupus erythematosus (SLE), an autoimmune disease where the body’s immune system mistakenly attacks its own tissues. Telitacicept has been approved in China and is aimed at helping patients who have not responded well to standard treatments. The researchers want to learn more about how well this drug works in Chinese patients and identify specific markers that could predict its effectiveness.

To participate in the study, patients need to have a confirmed diagnosis of SLE and show signs of active disease. They should also have been on stable conventional treatments for at least 30 days and have certain blood test results indicating disease activity. However, there are some exclusions; for instance, patients with severe kidney issues or recent serious health problems are not eligible. Those who join the trial can expect close monitoring and care to evaluate how well Telitacicept works for them. Overall, this study aims to improve understanding and treatment options for SLE in Chinese patients.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with a clinical diagnosis of SLE according to American College of Rheumatology (ACR) classification criteria 1997 and clinically active disease.
• • 2. Patients with good compliance, will sign the informed consent before the test.
• • 3. Patients who have received conventional treatment for SLE, and the type and dose of treatment drugs have been stable for at least 30 days.
• • 4. Patients who have a positive anti-nuclear antibody test result and SELENA-SLEDAI score ≥8 at screening. If there is a low complement and/or positive anti-dsDNA antibody, the SELENA-SLEDAI score can be defined as ≥ 6 points.
• Exclusion Criteria:
• • 1. Patients with severe lupus nephritis, defined as urinary protein \> 6g /24 hours or serum creatinine \> 221μmol/L within the last 2 months, or who require hemodialysis.
• • 2. Patients with SLE-caused or non-SLE-caused central nervous system disease within the last 2 months.
• • 3. Patients with severe condition in blood, important organs including heart, liver, gastrointestinal tract and endocrine system which are not related with SLE.
• • 4. Patients who use prednisone ≥100mg/d over 14 days or receive plasma replacement and suffer from active infection within the last 1 month.
• • 5. Patients who received any other targeted agents over the past 12 months.