■批准用于多发性硬化症(MS)的个体疾病改善疗法的有效性有限,并且可能会产生严重的副作用,尤其是长期服用时。序贯联合治疗是一种合理的替代方法。那他珠单抗是一种单克隆治疗性抗体,可减少白细胞进入中枢神经系统,这与进行性多灶性白质脑病和停药后疾病再激活的风险增加有关。克拉屈滨片剂作为合成腺苷类似物,破坏DNA合成和修复,从而减少淋巴细胞的数量。未来的产生,严格的安全性,从那他珠单抗过渡到克拉屈滨的疗效数据尚未满足临床需求。
■测试将复发形式的MS那他珠单抗患者过渡到克拉屈滨片的可行性。
■使用那他珠单抗(CLADRINA)治疗后的克拉屈滨片是一种开放标签,单臂,多中心,合作第四阶段,将产生关于安全性的假设的研究,功效,以及从那他珠单抗过渡到克拉屈滨片对复发性MS患者的免疫学影响。
■参与者将从三个不同的地点招募。主要终点是淋巴细胞和骨髓细胞亚群相对于基线的绝对和百分比变化,以及血液神经丝光水平。次要终点是12个月和24个月试验期间的年复发率。探索性终点包括扩展的残疾状况量表,和磁共振成像结果。
■CLADRINA试验将生成有关安全性的数据,功效,以及从那他珠单抗到克拉屈滨过渡的免疫学影响。随着MS免疫学知识的步伐继续,需要深入了解疾病改变治疗过渡策略。
UNASSIGNED: Individual disease modifying therapies approved for multiple sclerosis (MS) have limited effectiveness and potentially serious side effects, especially when administered over long periods. Sequential combination therapy is a plausible alternative approach. Natalizumab is a monoclonal therapeutic antibody that reduces leukocyte access to the central nervous system that is associated with an increased risk of progressive multifocal leukoencephalopathy and disease reactivation after its discontinuation. Cladribine tablets act as a synthetic adenosine analog, disrupting DNA synthesis and repair, thereby reducing the number of lymphocytes. The generation of prospective, rigorous safety, and efficacy data in transitioning from natalizumab to cladribine is an unmet clinical need.
UNASSIGNED: To test the feasibility of transitioning patients with relapsing forms of MS natalizumab to cladribine tablets.
UNASSIGNED: Cladribine tablets after treatment with natalizumab (CLADRINA) is an open-label, single-arm, multicenter, collaborative phase IV, research study that will generate hypothesis regarding the safety, efficacy, and immunological impact of transition from natalizumab to cladribine tablets in patients with relapsing forms of MS.
UNASSIGNED: Participants will be recruited from three different sites. The primary endpoint is the absolute and percent change from baseline of lymphocytes and myeloid cell subsets, as well as blood neurofilament light levels. The secondary endpoint is the annualized relapse rate over the 12- and 24-month trial periods. Exploratory endpoints include the expanded disability status scale, and magnetic resonance imaging outcomes.
UNASSIGNED: The CLADRINA trial will generate data regarding the safety, efficacy, and immunological impact of the transition from natalizumab to cladribine. As the pace of immunological knowledge of MS continues, insight into disease modifying therapy transition strategies is needed.