Safety, Efficacy, and Compliance of Telitacicept in the Treatment of Systemic Lupus Erythematosus (SLE)
NCT Number: NCT06458972
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Systemic Lupus Erythematosus
Sponsor: Tongji Hospital
Collaborators: Jingzhou Central Hospital|The First People's Hospital of Jingzhou|Wuhan Central Hospital|Zhongnan Hospital of Wuhan University|Xiangyang Central Hospital|Wuhan No.1 Hospital|China Three Gorges University, Yichang, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 139
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2024-08-31
Locations: Tongji Hospital, Wuhan, Hubei, 43003, China

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.

Primary Outcome Measures: 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|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|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|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|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|Serum complement C3 levels, Serum complement C3 levels (g/L), Baseline, Month 6, Month 12 after injecting Telitacecipt|Serum complement C4 levels, Serum complement C4 levels (g/L), Baseline, Month 6, Month 12 after injecting Telitacecipt|Serum immunoglobulin quantification, Serum immunoglobulin quantification (g/L), Baseline, Month 6, Month 12 after injecting Telitacecipt|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|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|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|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|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|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|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|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|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|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|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|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|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|Levels of tumor necrosis factor-α (TNF-α) levels, Levels of tumor necrosis factor-α (TNF-α) levels (pg/mL), Baseline and Month 6，Month 12 after injecting Telitacecipt|Levels of interferon-γ（IFN-γ） levels, Levels of interferon-γ（IFN-γ） levels (pg/mL), Baseline and Month 6，Month 12 after injecting Telitacecipt