An Exploratory Clinical Study on Telitacicept for the Treatment of Refractory Rheumatoid Arthritis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ACR20 at week 12
研究概览
简要总结
This is a single-center, single-arm, open-label, prospective study on the efficacy and safety of Telitacicept in patients with refractory rheumatoid arthritis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Telitacicept treatment group
Telitacicept added on previous treatment
干预措施: Telitacicept (Drug)
结局指标
主要结局
ACR20 at week 12
时间窗: Week 12
ACR20 is a comprehensive index defined as an improvement of at least 20% in both the number of tender and swollen joints, and improvement in at least three of the following five parameters by at least 20%: 1) Visual Analogue Scale (VAS) for pain, 2) patient's global assessment, 3) physician's global assessment, 4) Health Assessment Questionnaire (HAQ), and 5) acute-phase reactants (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)).
次要结局
- Change in glucocorticoid dosage(week 24)
- ACR20 at week 24(Week 24)
- The proportion of patients achieving DAS28 remission or low disease activity at week 12 and week 24(Week 12 and 24)
- The proportion of patients achieving SDAI remission or low disease activity at week 12 and week 24(Week 12 and 24)
- ACR50 at week 12 and 24(Week 12 and 24)
- ACR70 at week 12 and 24(Week 12 and 24)
- The proportion of patients achieving CDAI remission or low disease activity at week 12 and week 24(Week 12 and 24)
- Adverse events(during the study period and within 4 weeks after study completion)
研究者
Xinping Tian
Professor of medicine
Chinese SLE Treatment And Research Group