Telitacicept for the Treatment of Refractory RA

Официальное название

An Exploratory Clinical Study on Telitacicept for the Treatment of Refractory Rheumatoid Arthritis

Обзор

This is a single-center, single-arm, open-label, prospective study on the efficacy and safety of Telitacicept in patients with refractory rheumatoid arthritis.

Подробное описание

The treatment of rheumatoid arthritis (RA) has made significant progress over the past three decades. However, approximately 20-30% of patients remain resistant to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), biologic DMARDs (bDMARDs), and targeted synthetic DMARDs (tsDMARDs), presenting a major challenge in RA management. Telitacicept is a dual-target inhibitor of B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL). By inhibiting B cell maturation, differentiation, and antibody secretion by plasma cells, it reduces autoantibody production and the release of pro-inflammatory cytokines such as Tumor necrosis factor-α (TNF-α) and Interleukin-6 (IL-6), thereby alleviating joint inflammation. Clinically, a Phase III study of telitacicept in RA patients with inadequate response to methotrexate demonstrated a rapid onset of action within 4 weeks. At week 24, the ACR20 response rate in the 160 mg telitacicept group reached 67.4%, and at week 48, the response rate increased to 72.2%. Nearly 90% of patients exhibited no radiographic progression. In terms of safety, the incidence of adverse events with telitacicept was comparable to that of conventional therapies.

Currently, there are no clinical trials or registered studies investigating the use of telitacicept in the treatment of refractory RA. This study aims to evaluate the efficacy and safety of telitacicept in patients with refractory rheumatoid arthritis.

Вмешательства

• Препарат Telitacicept
  Telitacicept 160mg qw subcutaneous injection

Первичные конечные точки

• ACR20 at week 12 [Срок оценки: Week 12]

Вторичные конечные точки (8)

• ACR20 at week 24 [Срок оценки: Week 24]
• The proportion of patients achieving DAS28 remission or low disease activity at week 12 and week 24 [Срок оценки: Week 12 and 24]
• The proportion of patients achieving SDAI remission or low disease activity at week 12 and week 24 [Срок оценки: Week 12 and 24]
• ACR50 at week 12 and 24 [Срок оценки: Week 12 and 24]
• ACR70 at week 12 and 24 [Срок оценки: Week 12 and 24]
• The proportion of patients achieving CDAI remission or low disease activity at week 12 and week 24 [Срок оценки: Week 12 and 24]
• Change in glucocorticoid dosage [Срок оценки: week 24]
• Adverse events [Срок оценки: during the study period and within 4 weeks after study completion]

Критерии участия

Критерии включения

• Fulfill the classification criteria of the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR)
• Refractory RA definition: Insufficient response to a combination of at least two adequate doses of csDMARDs followed by bDMARDs (including but not limited to tumor necrosis factor inhibitors, interleukin-6 receptor inhibitors, T-cell costimulation molecule inhibitors, B-cell targeted drugs) or tsDMARDs (including but not limited to JAK inhibitors) for 12 weeks, with stable drug dosage for at least 6 weeks
• For patients treated with glucocorticoid therapy, they must have been on a stable dose of prednisone or prednisone equivalent ≤ 10 mg/day for at least 4 weeks before enrollment
• For patients treated with non-steroidal anti-inflammatory drugs, they must have been on a stable dose for at least 2 weeks before screening and enrollment
• ① Age > 18 years and < 70 years; ② Absolute neutrophil count ≥ 1.0 × 10⁹/L, platelet count ≥ 100 × 10⁹/L, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within 3 times the upper limit of normal, total bilirubin within 1.5 times the upper limit of normal, serum creatinine clearance rate > 60 ml/min; ③ Voluntarily sign the informed consent form

Критерии исключения

• Subjects with other autoimmune diseases
• Subjects with severe and poorly controlled cardiovascular, cerebrovascular, respiratory, liver, kidney, gastrointestinal, endocrine, hematological, or neurological diseases, or laboratory abnormalities that, in the opinion of the investigator, pose unacceptable risks for participation in the study
• Subjects with a history of malignancy (or less than 5 years since clinical remission)
• Subjects who are pregnant or breastfeeding, or plan to become pregnant or start breastfeeding during the study period
• Subjects who have received live virus vaccines within 4 weeks prior to enrollment in the study
• Subjects allergic to talizumab or any excipients
• Subjects who have participated in any other investigational drug trial within 12 weeks prior to the start of this study
• Subjects with active hepatitis or a history of severe liver disease at screening
• Subjects in the active phase of herpes zoster infection, or those who have experienced severe infections (requiring intravenous antibiotics or hospitalization) within 12 weeks prior to the start of the study medication
• Subjects with other conditions deemed unsuitable for enrollment by the investigator

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking Union Medical College Hospital — Пекин

Идентификаторы

NCT: NCT07008196 · Telitacicept-RA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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