An observational study in Systemic Lupus Erythematosus, sponsored by Tongji Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-11-19.
Sponsored by Tongji Hospital · Observational
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.
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's planned enrollment of 139 is close to the median of 140 across 283 observational studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Tongji Hospital is the lead sponsor of 373 studies on the registry; 204 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Systemic lupus erythematosus (SLE) is a highly specific autoimmune disease involving multiple systems caused by abnormal immune activation. It is a classic diffuse connective tissue disease characterized by autoimmune inflammation. Our study population is the people who confirmed diagnosis of systemic lupus erythematosus (SLE) by 2019 American College of Rheumatology/European League Against Rheumatism (2019ACR/EULAR) International classification diagnostic criteria and patients receiving Tacrolimus injections.
Exclusion Criteria:
Subjects who meet any of the following criteria should be excluded from this study:
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 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).
Time frame: Baseline, Month 6, Month 12 after injecting Telitacecipt
Serum complement C3 levels
Serum complement C3 levels (g/L)
Time frame: Baseline, Month 6, Month 12 after injecting Telitacecipt
Serum complement C4 levels
Serum complement C4 levels (g/L)
Time frame: Baseline, Month 6, Month 12 after injecting Telitacecipt
Serum immunoglobulin quantification
Serum immunoglobulin quantification (g/L)
Time frame: Baseline, Month 6, Month 12 after injecting Telitacecipt
Levels of C-reactive protein (CRP) levels
Levels of C-reactive protein (CRP) levels (mg/L)
Time frame: 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)
Time frame: Baseline and Month 6，Month 12 after injecting Telitacecipt
Levels of ferritin levels
Levels of ferritin levels (ug/L)
Time frame: 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
Time frame: 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.
Time frame: 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）
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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）
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline and Month 6，Month 12 after injecting Telitacecipt
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Tongji Hospital