Exploring the Therapeutic Effect of Telitacicept on Lupus Erythematosus Complicated With Thrombocytopenia

Systemic Lupus Erythematosus Clinical Trial

Official title:

A Randomized Controlled Trial Aimed at Exploring the Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus Patients With Refractory Thrombocytopenia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05929248
• Other study ID #: GGao
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2023
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: Gao Guanmin
• Phone: 13613716851
• Email: Guanmingao[@]zzu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of telitacicept in patients with systemic lupus erythematosus and refractory thrombocytopenia

Description:

This study is a single center, randomized, controlled trial to evaluate the efficacy of telitacicept in patients with systemic lupus erythematosus complicated with refractory thrombocytopenia.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Meets the 2012 ACR revised standards and meets four or more diagnostic criteria for systemic lupus erythematosus;

2. Refractory thrombocytopenia (defined as receiving at least one course of methylprednisolone pulse therapy or intravenous injection of high-dose immunoglobulin or high-dose glucocorticoid combined with two or more Immunosuppressive drug failed and did not respond to any single drug);

3. SLEENA-SLEDAI score is greater than or equal to 8 points. If anti ds-DNA antibody is positive and/or low complement, SLEENA-SLEDAI score is greater than or equal to 6 points, or PLT count is<10 * 10 ^ 9/L or<30 * 10 ^ 9/L with bleeding tendency;

4. Age greater than or equal to 18 years old and less than or equal to 65 years old;

5. Have a stable SLE treatment plan, and participants should receive standard treatment for at least 30 days before randomization; 6. Positive Antinuclear antibody or anti ds DNA antibody;

7. Sign informed documents.

Exclusion criteria:

Potential subjects who meet the inclusion criteria will be excluded if they meet any of the following criteria:

1. Patients who are allergic to tamoxifen;

2. Patients with severe active infection, history of tuberculosis, malignant tumor, HIV, hepatitis B, hepatitis C, important organs or hematopoietic stem cells/cells/bone marrow transplantation or kidney transplantation;

3. Patients with severe active central nervous system lupus and severe active lupus nephritis

4. Patients with diseases of liver, kidney, heart and other important organs, blood and Endocrine system;

5. Pregnant and lactating women;

6. Have a pregnancy preparation plan in the past year;

7. Those who have merged with other autoimmune diseases;

8. Incomplete case data and missing persons.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus
• Thrombocytopenia

Intervention

Drug:
• Telitacicept
160mg once a week for 48 weeks
• conventional therapy
Steroid(=1mg/kg/d) with or without proper immunosuppressants:CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.
• Placebo
Used once a week in combination with standard treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guanmin Gao

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The remission rate of SLE response index at month 12 of treatment	Use SRI-4 to represent the response index, with a higher response rate indicating better drug efficacy	months 12
Primary	Improvement in platelet count	Platelet count at month of treatment,Increased platelet count indicates improvement in disease	months 12
Secondary	Percentage of patients with a decrease of = 4 points in the SELENA-SLEDAI score from baseline at months 6 and 12	A decrease of = 4 points from baseline in the SELENA-SLEDAI score indicates a good drug response effect	months 6 and 12
Secondary	Hormone reduction	Changes in patient hormone dose from baseline at month 12,reduced hormone dosage indicates improvement in disease	month 12
Secondary	B lymphocyte count	Changes in patient B lymphocyte count from baseline at month 12	month 12