Safety and Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus (SLE)
- Conditions
- Systemic Lupus Erythematosus
- Registration Number
- NCT06458972
- Lead Sponsor
- Tongji Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 139
- Age ≥ 18 years old, not exceeding 70 years old (including 70 years old);
- Patients diagnosed with systemic lupus erythematosus (SLE) according to 2019 American College of Rheumatology/European League Against Rheumatism (2019ACR/EULAR) international classification diagnostic criteria;
- Accepting the treatment of telitacicept.
Subjects who meet any of the following criteria should be excluded from this study:
- Patients with other rheumatic immune system diseases;
- Patients in the active stage of acute and chronic infections;
- Patients using other biologics;
- Patients with wasting diseases such as malignant tumors
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index （SELENA-SLEDAI） Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt 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.
Physician's Global Assessment Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt 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.
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Baseline and Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt 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.
Serum anti-double stranded DNA (anti-dsDNA) Baseline, Month 6, Month 12 after injecting Telitacecipt to describe the qualitative feature of systemic lupus erythematosus (SLE) patients' serum anti-double stranded DNA (anti-dsDNA).
Serum complement C3 levels Baseline, Month 6, Month 12 after injecting Telitacecipt Serum complement C3 levels (g/L)
Serum complement C4 levels Baseline, Month 6, Month 12 after injecting Telitacecipt Serum complement C4 levels (g/L)
Serum immunoglobulin quantification Baseline, Month 6, Month 12 after injecting Telitacecipt Serum immunoglobulin quantification (g/L)
Levels of C-reactive protein (CRP) levels Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt Levels of C-reactive protein (CRP) levels (mg/L)
Levels of interleukin-10 (IL-10) levels Baseline and Month 6，Month 12 after injecting Telitacecipt Levels of interleukin-10 (IL-10) levels (pg/mL)
Levels of ferritin levels Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt Levels of ferritin levels (ug/L)
the safety of telitacicept for SLE patients Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt The probability of adverse reactions （Local adverse reactions after injection） and the probability of major drug-related adverse events
the reasons for medication discontinuation Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt 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.
Levels of leukocyte levels Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt Levels of leukocyte levels （\*10\^9/L）
Levels of hemoglobin (Hb) levels Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt Levels of hemoglobin (Hb) levels (g/L)
Levels of blood platelet (PLT) levels Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt Levels of blood platelet (PLT) levels (\*10\^9/L)
routine urine test Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt To evaluate the grade of urine occult blood and urine protein
Levels of erythrocyte sedimentation rate (ESR) levels Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt Levels of erythrocyte sedimentation rate (ESR) levels (mm/h）
Levels of interleukin-6 (IL-6) levels Baseline and Month 6，Month 12 after injecting Telitacecipt Levels of interleukin-6 (IL-6) levels (pg/mL)
Levels of interleukin-4 (IL-4) levels Baseline and Month 6，Month 12 after injecting Telitacecipt Levels of interleukin-4 (IL-4) levels (pg/mL)
Levels of interleukin-2 (IL-2) levels Baseline and Month 6，Month 12 after injecting Telitacecipt Levels of interleukin-2 (IL-2) levels (pg/mL)
Levels of tumor necrosis factor-α (TNF-α) levels Baseline and Month 6，Month 12 after injecting Telitacecipt Levels of tumor necrosis factor-α (TNF-α) levels (pg/mL)
Levels of interferon-γ（IFN-γ） levels Baseline and Month 6，Month 12 after injecting Telitacecipt Levels of interferon-γ（IFN-γ） levels (pg/mL)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Tongji Hospital
🇨🇳Wuhan, Hubei, China