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Набор скоро начнётся NCT07069972

A Prospective Comparative Study Involving Multiple Units to Evaluate the Efficacy and Safety of Telitacicept and Belimumab in the Treatment of Systemic Lupus Erythematosus.

— Наблюдательное Systemic Lupus Erythematosus

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Systemic Lupus Erythematosus. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

Comparing Efficacy and Safety of Telitacicept and Belimumab in Systemic Lupus Erythematosus: A Prospective Multicenter Cohort Study.

Обзор

The objective of this observational study is to compare the efficacy and safety of telitacicept versus belimumab in systemic lupus erythematosus (SLE) patients aged 18-65 years. The primary questions it aims to answer are: * In the overall SLE population: What are the SRI-4 response rates for both drugs? * In the lupus nephritis subgroup: What are the major renal response rates for both drugs? Participants will autonomously select their treatment regimen (add-on telitacicept or belimumab) based on: * The patient's objective clinical condition at enrollment * Physician's assessment * Joint decision-making between physicians and patients/family members As an observational study, no active intervention will be implemented.

Первичные конечные точки

  • The percentage of patients with a Systemic Lupus Erythematosus Response Index-4 (SRI-4) response(the overall SLE population) [Срок оценки: From baseline to the end of 2-year treatment period]
  • The response rate for major kidney treatments(the lupus nephritis subgroup) [Срок оценки: From baseline to the end of 2-year treatment period]
Вторичные конечные точки (4)
  • Complete renal response rate(the lupus nephritis subgroup) [Срок оценки: From baseline to the end of 2-year treatment period]
  • Proportion of Participants with Stable SLEDAI and PGA Scores(the overall SLE population) [Срок оценки: From baseline to the end of 2-year treatment period]
  • The proportion of participants in the study who had their hormone dosage reduced(the overall SLE population) [Срок оценки: From baseline to the end of 2-year treatment period]
  • The time of recurrence occurrence(the overall SLE population) [Срок оценки: From baseline to the end of 2-year treatment period.]

Критерии участия

Критерии включения

  • Age range: 18 - 65 years old;
  • Meets the revised SLE classification criteria of the American College of Rheumatology in 1997 or the SLE diagnostic classification criteria issued by EULAR/ACR in 2019;
  • The SELENA-SLEDAI score is at least 8 points (clinical symptoms are no less than 6 points, excluding positive anti-double-stranded DNA (anti-dsDNA) and low complement);
  • Has not responded well to hormone and/or immunosuppressant treatment, is intolerant or has recurrence, and is willing to accept tixocortinib/belimumab as a therapeutic drug.

Критерии исключения

  • Any of the following conditions exists: active central nervous system disease, severe active lupus nephritis, HIV infection, hepatitis B or C virus infection, low gamma globulinemia, liver dysfunction;
  • eGFR < 30 mL/min/1.73m², or undergoing hemodialysis or kidney transplantation;
  • Pregnant women, or women who are about to become pregnant in the near future, or lactating women;
  • Participants who are simultaneously participating in other clinical studies;
  • Within 1 year before randomization, received B-cell targeted therapy (including belimumab);
  • During treatment, used traditional Chinese medicine with immunosuppressive effects (such as Tripterygium wilfordii, White Peony Root, etc.) in combination.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Qianfoshan Hospital — Цзинань

Идентификаторы

NCT: NCT07069972 · YXLL-KY-2025(106)

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗