Effect of Telitacicept on Transitional Regulatory B Cells in Patients With Systemic Lupus Erythematosus
Study Details
Study Description
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 in SLE.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Exposed group Standard treatment for SLE + Telitacicept 160 mg qw |
|
| Control group Standard treatment for SLE |
Outcome Measures
Primary Outcome Measures
- Number of transitional regulatory B cells [prior treatment]
"A subset of B cells, including T1 and T2 B cells, that secrete immunosuppressive factors and act as negative immune regulators.
- Number of transitional regulatory B cells [After 12 weeks of treatment]
"A subset of B cells, including T1 and T2 B cells, that secrete immunosuppressive factors and act as negative immune regulators.
- Number of transitional regulatory B cells [After 24 weeks of treatment]
"A subset of B cells, including T1 and T2 B cells, that secrete immunosuppressive factors and act as negative immune regulators.
- Number of transitional regulatory B cells [After 36 weeks of treatment]
"A subset of B cells, including T1 and T2 B cells, that secrete immunosuppressive factors and act as negative immune regulators.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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 Criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yanfeng Hou | Jinan | Shandong | China | 250000 |
Sponsors and Collaborators
- Yanfeng Hou
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZGC2022-11-26