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

NCT ID: NCT05929248

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-12-30

Brief Summary

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

Detailed 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.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

conventional treatment plus Telitacicept 160 mg sc per week

Group Type: EXPERIMENTAL

Telitacicept

Intervention Type: DRUG

160mg once a week for 48 weeks

conventional therapy

Intervention Type: DRUG

Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.

Control group

Placebo plus conventional treatment

Group Type: PLACEBO_COMPARATOR

conventional therapy

Intervention Type: DRUG

Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.

Placebo

Intervention Type: DRUG

Used once a week in combination with standard treatment

Interventions

Telitacicept

160mg once a week for 48 weeks

Intervention Type: DRUG

conventional therapy

Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.

Intervention Type: DRUG

Placebo

Used once a week in combination with standard treatment

Intervention Type: DRUG

Other Intervention Names

RC18

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guanmin Gao

OTHER

Sponsor Role: lead

Responsible Party

Guanmin Gao

chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gao Guanmin

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhengzhou University

Central Contacts

Gao Guanmin

Role: CONTACT

Guanmingao@zzu.edu.cn

13613716851

Other Identifiers

GGao

Identifier Type: -

Identifier Source: org_study_id