Safety, Efficacy, and Compliance of Telitacicept in the Treatment of Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus Clinical Trial

Official title:

Safety, Efficacy, and Compliance of Telitacicept in the Treatment of Systemic Lupus Erythematosus (SLE) in the Real World: a Multicenter Retrospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06458972
• Other study ID #: TJ-IRB20231298
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: June 2024
• Source: Tongji Hospital
• Contact: Dong Lingli, MD
• Phone: +862783665519
• Email: tjhdongll[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Systemic lupus erythematosus (SLE) is a highly specific autoimmune disease that involves multiple systems due to abnormal immune activation. It is a classical diffuse connective tissue disease with autoimmune inflammation as its prominent manifestation. B cells are the core of systemic lupus erythematosus (SLE) pathogenesis. B Lymphocyte Stimulator (BLyS, also called BAFF) and A Proliferation-Inducing Ligand (APRIL) are signals for B cell maturation. B Lymphocyte Stimulator (BLyS) participates in promoting the development and maturation of B cells, while A Proliferation-Inducing Ligand (APRIL) participates in promoting the activation of mature B cells and the secretion of antibodies by plasma cells. Telitacicept is composed of the extracellular specific soluble portion of Transmembrane Activator and Calcium-modulating Cyclophilin Ligand (CAML) Interactor (TACI) and the Fragment crystallizable (Fc) segment of human Immunoglobulin G1 (IgG1). It is the only globally approved dual-target biological agent for the treatment of systemic lupus erythematosus (SLE) , blocking B Lymphocyte Stimulator (BLyS) and A Proliferation-Inducing Ligand (APRIL), hindering the development and activation of B cells, and the production of antibodies, comprehensively inhibiting the maturation, proliferation, and differentiation of B cells at different stages. In this study, the investigators will explore the adherence and influencing factors of telitacicept in systemic lupus erythematosus (SLE) patients, its effectiveness, and safety, providing a stronger basis for clinical management of systemic lupus erythematosus (SLE) patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 139
• Est. completion date: August 31, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age = 18 years old, not exceeding 70 years old (including 70 years old);

2. Patients diagnosed with systemic lupus erythematosus (SLE) according to 2019 American College of Rheumatology/European League Against Rheumatism (2019ACR/EULAR) international classification diagnostic criteria;

3. Accepting the treatment of telitacicept.

Exclusion Criteria:

Subjects who meet any of the following criteria should be excluded from this study:

1. Patients with other rheumatic immune system diseases;

2. Patients in the active stage of acute and chronic infections;

3. Patients using other biologics;

4. Patients with wasting diseases such as malignant tumors

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (8)

Lead Sponsor	Collaborator
Tongji Hospital	China Three Gorges University, Yichang, China, Jingzhou Central Hospital, The First People's Hospital of Jingzhou, Wuhan Central Hospital, Wuhan No.1 Hospital, Xiangyang Central Hospital, Zhongnan Hospital of Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)	Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) is a cumulative and weighted index used to assess disease activity across 24 different disease descriptors in patients with SLE. It is scored by a table named "SELENA-SLEDAI (Systemic Lupus Erythematosus Disease Activity Index) INSTRUMENT SCORE" . The minimum and maximum values are 0 points and 105 points separately, but very few patients score higher than 45 points. Higher scores indicate higher disease activity.	Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Primary	Physician's Global Assessment	Physician's global assessment for patients with Systemic Lupus Erythematosus (SLE) is a subjective assessment tool used by a same physicians to evaluate the overall disease activity based on clinical observations and patient reports(the patient's symptoms, physical examination findings, laboratory results, and any other relevant clinical information). The physician's global assessment (PGA) scale typically ranges from 0 to 3, with 0 representing no disease activity and 3 representing severe disease activity. Some variations of the scale may include intermediate markers, such as 1 and 2, to indicate varying degrees of disease activity.	Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Primary	Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)	Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a questionnaire-based tool (FACIT-F, Vision 4) used to measure fatigue in patients. It consists of multiple items, each focusing on a different aspect of fatigue. The items are typically rated on a scale from 0 to 4, with 0 representing "not at all" and 4 representing "very much". Example items include: "I feel tired" or "I'm too tired to working". Higher scores indicate less fatigue.	Baseline and Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Primary	Eight-Item Morisky Medication Adherence Scale(MMAS-8)	Eight-Item Morisky Medication Adherence Scale(MMAS-8) is a valid and reliable scale developed to evaluate medication adherence among patients. It consists of 8 items designed to capture different aspects of medication-taking behavior. Each question has binary response options (yes/no). The responses are scored according to a predefined scoring system. The total score ranges from 0 to 8. 8 points indicate excellent adherence. 6-7 points indicate moderate adherence. Less than 6 points indicate poor adherence.	Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Primary	Serum anti-double stranded DNA (anti-dsDNA)	to describe the qualitative feature of systemic lupus erythematosus (SLE) patients' serum anti-double stranded DNA (anti-dsDNA).	Baseline, Month 6, Month 12 after injecting Telitacecipt
Primary	Serum complement C3 levels	Serum complement C3 levels (g/L)	Baseline, Month 6, Month 12 after injecting Telitacecipt
Primary	Serum complement C4 levels	Serum complement C4 levels (g/L)	Baseline, Month 6, Month 12 after injecting Telitacecipt
Primary	Serum immunoglobulin quantification	Serum immunoglobulin quantification (g/L)	Baseline, Month 6, Month 12 after injecting Telitacecipt
Primary	Levels of C-reactive protein (CRP) levels	Levels of C-reactive protein (CRP) levels (mg/L)	Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Primary	Levels of interleukin-10 (IL-10) levels	Levels of interleukin-10 (IL-10) levels (pg/mL)	Baseline and Month 6,Month 12 after injecting Telitacecipt
Primary	Levels of ferritin levels	Levels of ferritin levels (ug/L)	Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Primary	the safety of telitacicept for SLE patients	The probability of adverse reactions (Local adverse reactions after injection) and the probability of major drug-related adverse events	Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Primary	the reasons for medication discontinuation	The investigators will survey the reasons for medication discontinuation by telephone or outpatient follow-up ,the different reasons include economic reasons? disease improved or be a stable condition? poor effect? arise adverse reaction, etc.	Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Primary	Levels of leukocyte levels	Levels of leukocyte levels (*10^9/L)	Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Primary	Levels of hemoglobin (Hb) levels	Levels of hemoglobin (Hb) levels (g/L)	Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Primary	Levels of blood platelet (PLT) levels	Levels of blood platelet (PLT) levels (*10^9/L)	Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Primary	routine urine test	To evaluate the grade of urine occult blood and urine protein	Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Primary	Levels of erythrocyte sedimentation rate (ESR) levels	Levels of erythrocyte sedimentation rate (ESR) levels (mm/h)	Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Primary	Levels of interleukin-6 (IL-6) levels	Levels of interleukin-6 (IL-6) levels (pg/mL)	Baseline and Month 6,Month 12 after injecting Telitacecipt
Primary	Levels of interleukin-4 (IL-4) levels	Levels of interleukin-4 (IL-4) levels (pg/mL)	Baseline and Month 6,Month 12 after injecting Telitacecipt
Primary	Levels of interleukin-2 (IL-2) levels	Levels of interleukin-2 (IL-2) levels (pg/mL)	Baseline and Month 6,Month 12 after injecting Telitacecipt
Primary	Levels of tumor necrosis factor-a (TNF-a) levels	Levels of tumor necrosis factor-a (TNF-a) levels (pg/mL)	Baseline and Month 6,Month 12 after injecting Telitacecipt
Primary	Levels of interferon-?(IFN-?) levels	Levels of interferon-?(IFN-?) levels (pg/mL)	Baseline and Month 6,Month 12 after injecting Telitacecipt