Clinical trial NCT05929248: Exploring the Therapeutic Effect of Telitacicept on Lupus Erythematosus Complicated With Thrombocytopenia
Official title: A Randomized Controlled Trial Aimed at Exploring the Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus Patients With Refractory Thrombocytopenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: lupus erythematosus
Telitacicept
thrombocytopenia
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: The remission rate of SLE response index at month 12 of treatment
timeFrame: months 12
measure: Improvement in platelet count
timeFrame: months 12
Secondary outcomes:
measure: Percentage of patients with a decrease of ≥ 4 points in the SELENA-SLEDAI score from baseline at months 6 and 12
timeFrame: months 6 and 12
measure: Hormone reduction
timeFrame: month 12
measure: B lymphocyte count
timeFrame: month 12
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Gao Guanmin
role: PRINCIPAL_INVESTIGATOR
References: