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

NCT06458972 | Recruiting

• 1 other identifier: TJ-IRB20231298
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus; Telitacicept; adherence; safety; effectiveness

Outcome Measures

Primary Outcomes (22)

• 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

• 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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tongji Hospital: lead
• Jingzhou Central Hospital: collaborator
• Wuhan Central Hospital: collaborator
• Xiangyang Central Hospital: collaborator
• Wuhan No.1 Hospital: collaborator
• China Three Gorges University, Yichang, China: collaborator
• Shanghai Zhongshan Hospital: collaborator
• The First People's Hospital of Jingzhou: collaborator

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 43003, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Dong Lingli, MD

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Lingli, MD

CONTACT

17742804229; tjhdongll@163.com

Cai Shaozhe, MD

CONTACT

15623423810; 540361903@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 14, 2024
• Study Start: January 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-09

Locations

CN (1)