Clinical trial NCT06458972: Safety and Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus (SLE)
Official title: Safety and Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus (SLE) in the Real World: a Multicenter Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic Lupus Erythematosus
Telitacicept
adherence
safety
effectiveness
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Jingzhou Central Hospital
name: Wuhan Central Hospital
name: Xiangyang Central Hospital
name: Wuhan No.1 Hospital
name: China Three Gorges University, Yichang, China
name: Shanghai Zhongshan Hospital
name: The First People&#39;s Hospital of Jingzhou
First posted: 2024-06-14
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index （SELENA-SLEDAI）
timeFrame: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
measure: Physician's Global Assessment
timeFrame: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
measure: Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
timeFrame: Baseline and Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
measure: Serum anti-double stranded DNA (anti-dsDNA)
timeFrame: Baseline, Month 6, Month 12 after injecting Telitacecipt
measure: Serum complement C3 levels
timeFrame: Baseline, Month 6, Month 12 after injecting Telitacecipt
measure: Serum complement C4 levels
timeFrame: Baseline, Month 6, Month 12 after injecting Telitacecipt
measure: Serum immunoglobulin quantification
timeFrame: Baseline, Month 6, Month 12 after injecting Telitacecipt
measure: Levels of C-reactive protein (CRP) levels
timeFrame: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
measure: Levels of interleukin-10 (IL-10) levels
timeFrame: Baseline and Month 6，Month 12 after injecting Telitacecipt
measure: Levels of ferritin levels
timeFrame: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
measure: the safety of telitacicept for SLE patients
timeFrame: Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
measure: the reasons for medication discontinuation
timeFrame: Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
measure: Levels of leukocyte levels
timeFrame: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
measure: Levels of hemoglobin (Hb) levels
timeFrame: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
measure: Levels of blood platelet (PLT) levels
timeFrame: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
measure: routine urine test
timeFrame: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
measure: Levels of erythrocyte sedimentation rate (ESR) levels
timeFrame: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
measure: Levels of interleukin-6 (IL-6) levels
timeFrame: Baseline and Month 6，Month 12 after injecting Telitacecipt
measure: Levels of interleukin-4 (IL-4) levels
timeFrame: Baseline and Month 6，Month 12 after injecting Telitacecipt
measure: Levels of interleukin-2 (IL-2) levels
timeFrame: Baseline and Month 6，Month 12 after injecting Telitacecipt
measure: Levels of tumor necrosis factor-α (TNF-α) levels
timeFrame: Baseline and Month 6，Month 12 after injecting Telitacecipt
measure: Levels of interferon-γ（IFN-γ） levels
timeFrame: Baseline and Month 6，Month 12 after injecting Telitacecipt
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Dong Lingli, MD
role: PRINCIPAL_INVESTIGATOR
References: