Status:
UNKNOWN
Effect of Telitacicept on Transitional Regulatory B Cells in Patients With Systemic Lupus Erythematosus
Lead Sponsor:
Yanfeng Hou
Conditions:
Telitacicept
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-70 years
Brief Summary
The effect of Telitacicept treatment on the changes of transitional regulatory B lymphocyte T1, T2B cell subsets and plasma blasts and the expression levels of cytokines IL-10, IL-35, April and BAFF i...
Eligibility Criteria
Inclusion
- The diagnosis meets the 2019 EULAR/ACR classification criteria for SLE;
- Age 18-70 years old;
- To be on a stable SLE regimen, participants were required to receive standard treatment at least 1 month prior to treatment with a biologic (Telitacicept);
- Lupus activity Index score (SELENA-SLEDAI) ≥ 8 at screening;
- Positive anti-nuclear antibody or anti-DSDNA antibody;
- Combined antiphospholipid syndrome should meet the diagnostic criteria: that is, meet one clinical criterion and one laboratory criterion.
Exclusion
- Active infections (such as shingles, HIV infection, active tuberculosis, etc.) during the screening period;
- Central nervous system disease (including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis) caused by SLE or not caused by SLE in the last 2 months;
- Have active hepatitis or a history of severe liver disease;
- Patients with immune deficiency, uncontrolled severe infection, and active or recurrent digestive ulcer;
- Pregnant women, breastfeeding women and men or women who have planned to have a baby in the last 12 months;
- Allergic reaction: history of allergic reaction to human biological products;
- Those who received live vaccine within the last month;
- Participants who have participated in any clinical trial within 28 days prior to initial screening/or 5 times the half-life of the study compound (taking an older time);
- B cell targeted therapy, such as rituximab or epazumab, within one year;
- Use tumor necrosis factor inhibitors and interleukin-receptor blockers within one year;
- Patients receiving intravenous gamma globulin (IVIG), prednisone ≥ 100 mg/d for more than 14 days within one month or undergoing plasmapheresis;
- Psychopaths with depression or suicidal thoughts.
Key Trial Info
Start Date :
November 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06137053
Start Date
November 1 2022
End Date
December 31 2025
Last Update
November 21 2023
Active Locations (1)
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1
Yanfeng Hou
Jinan, Shandong, China, 250000