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NCT Number: NCT06458972

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

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index （SELENA-SLEDAI）

    Time frame: 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.

  2. Physician's Global Assessment

    Time frame: 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.

  3. Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)

    Time frame: 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.

  4. Serum anti-double stranded DNA (anti-dsDNA)

    Time frame: 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).

  5. Serum complement C3 levels

    Time frame: Baseline, Month 6, Month 12 after injecting Telitacecipt

    Serum complement C3 levels (g/L)

  6. Serum complement C4 levels

    Time frame: Baseline, Month 6, Month 12 after injecting Telitacecipt

    Serum complement C4 levels (g/L)

  7. Serum immunoglobulin quantification

    Time frame: Baseline, Month 6, Month 12 after injecting Telitacecipt

    Serum immunoglobulin quantification (g/L)

  8. Levels of C-reactive protein (CRP) levels

    Time frame: 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)

  9. Levels of interleukin-10 (IL-10) levels

    Time frame: Baseline and Month 6，Month 12 after injecting Telitacecipt

    Levels of interleukin-10 (IL-10) levels (pg/mL)

  10. Levels of ferritin levels

    Time frame: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt

    Levels of ferritin levels (ug/L)

  11. the safety of telitacicept for SLE patients

    Time frame: 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

  12. the reasons for medication discontinuation

    Time frame: 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.

  13. Levels of leukocyte levels

    Time frame: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt

    Levels of leukocyte levels （*10^9/L）

  14. Levels of hemoglobin (Hb) levels

    Time frame: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt

    Levels of hemoglobin (Hb) levels (g/L)

  15. Levels of blood platelet (PLT) levels

    Time frame: 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)

  16. routine urine test

    Time frame: 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

  17. Levels of erythrocyte sedimentation rate (ESR) levels

    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 (mm/h）

  18. Levels of interleukin-6 (IL-6) levels

    Time frame: Baseline and Month 6，Month 12 after injecting Telitacecipt

    Levels of interleukin-6 (IL-6) levels (pg/mL)

  19. Levels of interleukin-4 (IL-4) levels

    Time frame: Baseline and Month 6，Month 12 after injecting Telitacecipt

    Levels of interleukin-4 (IL-4) levels (pg/mL)

  20. Levels of interleukin-2 (IL-2) levels

    Time frame: Baseline and Month 6，Month 12 after injecting Telitacecipt

    Levels of interleukin-2 (IL-2) levels (pg/mL)

  21. Levels of tumor necrosis factor-α (TNF-α) levels

    Time frame: Baseline and Month 6，Month 12 after injecting Telitacecipt

    Levels of tumor necrosis factor-α (TNF-α) levels (pg/mL)

  22. Levels of interferon-γ（IFN-γ） levels

    Time frame: Baseline and Month 6，Month 12 after injecting Telitacecipt

    Levels of interferon-γ（IFN-γ） levels (pg/mL)

Study contacts

Contact information is provided by the study sponsor or research team.

Cai Shaozhe, MD

CONTACT

[email protected]

15623423810

Dong Lingli, MD

CONTACT

[email protected]

17742804229

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Collaborators

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

Registry information

Official study title

Safety and Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus (SLE) in the Real World: a Multicenter Retrospective Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 14, 2024
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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