NCT07796516招募中2 期
Efficacy and Safety of Telitacicept in the Treatment of Refractory Rheumatoid Arthritis: A Multicenter, Open-Label, Randomized Controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 420
- 试验地点
- 47
- 主要终点
- ACR20 response rate
研究概览
简要总结
This study is a multicenter, open-label, randomized controlled trial designed to preliminarily evaluate the efficacy and safety of telitacicept in patients with refractory rheumatoid arthritis during a 24-week treatment period followed by a 2-week follow-up period.
详细描述
The refractory rheumatoid arthritis is a heterogeneous subgroup of RA patients, whose disease has not been satisfactorily controlled with several lines of DMARDs using the treat-to-target strategy. In 2024, telitacicept was approved for the treatment of rheumatoid arthritis in China, and several case reports have demonstrated its efficacy in refractory RA.
This study plans to enroll 420 adult patients with difficult-to-treat rheumatoid arthritis, randomized in a 1:1 ratio to receive either telitacicept (160mg qw) plus standard therapy or standard therapy alone for 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female participants of age >18 years will be enrolled;
- •Meet the 2021 EULAR criteria for the diagnosis of difficult-to-treat rheumatoid arthritis;
- •The dose of prednisone should be ≤10 mg or equivalent dose of corticosteroids, and the dose must remain unchanged for at least 4 weeks;
- •Consent to use effective contraception during the study period (women of childbearing age);
- •Voluntarily signed informed consent.
排除标准
- •Those with specific allergy history (asthma, urticaria, eczema, etc.), or allergic constitution, or hypersensitivity to any component of telitacicept;
- •Subjects who have received intra-articular, intravenous, intramuscular, or intrarectal (excluding suppositories for anal diseases) corticosteroids within 4 weeks prior to baseline;
- •Subjects who have used Tripterygium wilfordii glycosides, total glucosides of paeony, Huobahuagen tablets, or other immunosuppressive or anti-inflammatory traditional Chinese medicines or decoctions within 4 weeks prior to baseline;
- •Subjects currently using non-steroidal anti-inflammatory drugs (excluding acetaminophen) whose dose has not been stable for 4 weeks prior to randomization, or who are unable to continue treatment at the original dose during the trial;
- •Subjects with abnormal laboratory parameters, including but not limited to the following:
- •White blood cell count < 2.0 × 10⁹/L;
- •Neutrophils < 1.0 × 10⁹/L;
- •Hemoglobin < 80 g/L;
- •Platelet count < 50 × 10⁹/L;
- •Serum creatinine > 2 × ULN or creatinine clearance (CCr) ≤ 50 mL/min
- •Total bilirubin > 2 × ULN, ALT > 3 × ULN, AST > 3 × ULN, alkaline phosphatase > 2 × ULN;
- •Female subjects who are pregnant or breastfeeding;
- •Those with other systemic inflammatory diseases other than RA (excluding secondary Sjögren's syndrome), including but not limited to juvenile chronic arthritis, Crohn's disease, ulcerative colitis, psoriatic arthritis, systemic lupus erythematosus, ankylosing spondylitis, reactive arthropathy, systemic vasculitis, or gout;
- •Those with non-inflammatory refractory arthritis (NIRRA) (few or no swollen joints, normal CRP concentration, non-erosive pathology);
- •Subjects who test positive for any one or more of the following: hepatitis B surface antigen, hepatitis C virus antibody, syphilis-specific antibody, or human immunodeficiency virus antibody;
- •Subjects with active infection at screening, or who have had an infection requiring systemic treatment within 1 month prior to screening, or who are at high risk of infection;
- •Subjects with clinical, radiological, or laboratory evidence of active tuberculosis at screening;
- •Subjects with clinically significant cardiovascular, respiratory, digestive, endocrine, hematologic, neurological, or psychiatric disorders, or any other serious and/or unstable disease or history thereof, that in the investigator's opinion would pose a safety risk if participating in this study;
- •Subjects with other primary malignancies;
- •Subjects with a history of herpes zoster, major cardiovascular events, thromboembolism, or lymphoproliferative disease;
- •Investigator considers candidates not appropriating for the study.
研究组 & 干预措施
Telitacicept plus standard therapy group
Experimental
干预措施: Standard therapy (Drug)
Standard therapy group
Active Comparator
Standard therapy includes disease-modifying antirheumatic drugs (DMARDs), glucocorticoids and non-steroidal anti-inflammatory drugs.
干预措施: Standard therapy (Drug)
Telitacicept plus standard therapy group
Experimental
干预措施: Telitacicept 160mg (Biological)
结局指标
主要结局
ACR20 response rate
时间窗: Week 24
次要结局
- Change from baseline in SDAI(Week 24)
- The proportion of subjects achieving SDAI ≤ 3.3(Week 24)
- Change from baseline in CDAI(Week 24)
- The proportion of subjects achieving CDAI ≤ 2.8(Week 24)
- ACR50 and ACR70 response rates(Week 24)
研究者
Zhanguo Li
Dept. Rheumatology and Immunology
Peking University People's Hospital
研究点 (47)
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