NCT06458972 Safety and Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus (SLE)
| NCT ID | NCT06458972 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tongji Hospital |
| Condition | Systemic Lupus Erythematosus |
| Study Type | OBSERVATIONAL |
| Enrollment | 139 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2024-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 139 participants in total. It began in 2024-01-01 with a primary completion date of 2024-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Dong Lingli, MD
PRINCIPAL INVESTIGATOR
Tongji Hospital
Frequently Asked Questions
Who can join the NCT06458972 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Systemic Lupus Erythematosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06458972 currently recruiting?
Yes, NCT06458972 is actively recruiting participants. Contact the research team at tjhdongll@163.com for enrollment information.
Where is the NCT06458972 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT06458972 clinical trial?
NCT06458972 is sponsored by Tongji Hospital. The principal investigator is Dong Lingli, MD at Tongji Hospital. The trial plans to enroll 139 participants.
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