Oral Cladribine in Patients who Change From First-Line Disease Modifying Treatments for Multiple Sclerosis: Protocol of a Prospective Effectiveness and Safety Study (CLAD CROSS)

IF 2.6 Q2 CLINICAL NEUROLOGY Journal of Central Nervous System Disease Pub Date : 2022-01-01 DOI:10.1177/11795735211069441
G. Tsivgoulis, S. Deftereos, C. Gobbi, Elisabeth Gulowsen Celius, A. Kułakowska, G. Maniscalco, Irene Mendes, N. Grigoriadis
{"title":"Oral Cladribine in Patients who Change From First-Line Disease Modifying Treatments for Multiple Sclerosis: Protocol of a Prospective Effectiveness and Safety Study (CLAD CROSS)","authors":"G. Tsivgoulis, S. Deftereos, C. Gobbi, Elisabeth Gulowsen Celius, A. Kułakowska, G. Maniscalco, Irene Mendes, N. Grigoriadis","doi":"10.1177/11795735211069441","DOIUrl":null,"url":null,"abstract":"Background Recently, the number of available disease modifying therapies for multiple sclerosis (MS) has increased. However, a proportion of patients treated with these agents continue to experience relapses and disease progression. Cladribine tablets, approved in 2017 for highly active relapsing MS, comprise a sparsely administered oral treatment which exerts its therapeutic effect through a reduction and subsequent repletion of the lymphocyte population. Purpose/Study Sample Here we describe the design of CLAD CROSS, a prospective, non-interventional, multicenter, Phase IV study in patients with a confirmed diagnosis of RRMS who switch from first-line disease modifying drugs (DMDs) to treatment with cladribine tablets in routine clinical practice. 242 adult patients will be recruited in 61 sites (6 countries) over 30 months and will be followed up for 2 years following prescription of cladribine tablets per the decision of the treating physicians. Research Design The primary endpoint is the change in annualized relapse rate (ARR) between the 12-month pre-baseline period and over the 12-month period before end of study. Secondary endpoints are the percentage of patients with 6-month disability progression or improvement at the end of the study, measured by the Expanded Disability Status Scale, Timed 25 Foot Walk and 9-Hole Peg Test scales and quality of life, treatment satisfaction, and healthcare resource utilization, measured through the MSIS-29, TSQM 1.4, and EQ-5D-3L scales, respectively. MRI lesions will be compared in the exploratory setting between the 12-month pre-baseline period, baseline, and at years 1 and 2. Adverse events will be monitored throughout the study. Interim analyses are pre-planned when 30% and 60% of patients will complete the 12-month follow-up visit. Conclusions CLAD CROSS will provide efficacy data on cladribine tablets, used as a follow-up treatment to first-line DMDs in the real-world setting, will further establish its safety profile and will collect information to support pharmacoeconomic studies.","PeriodicalId":15218,"journal":{"name":"Journal of Central Nervous System Disease","volume":null,"pages":null},"PeriodicalIF":2.6000,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Central Nervous System Disease","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/11795735211069441","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
引用次数: 1

Abstract

Background Recently, the number of available disease modifying therapies for multiple sclerosis (MS) has increased. However, a proportion of patients treated with these agents continue to experience relapses and disease progression. Cladribine tablets, approved in 2017 for highly active relapsing MS, comprise a sparsely administered oral treatment which exerts its therapeutic effect through a reduction and subsequent repletion of the lymphocyte population. Purpose/Study Sample Here we describe the design of CLAD CROSS, a prospective, non-interventional, multicenter, Phase IV study in patients with a confirmed diagnosis of RRMS who switch from first-line disease modifying drugs (DMDs) to treatment with cladribine tablets in routine clinical practice. 242 adult patients will be recruited in 61 sites (6 countries) over 30 months and will be followed up for 2 years following prescription of cladribine tablets per the decision of the treating physicians. Research Design The primary endpoint is the change in annualized relapse rate (ARR) between the 12-month pre-baseline period and over the 12-month period before end of study. Secondary endpoints are the percentage of patients with 6-month disability progression or improvement at the end of the study, measured by the Expanded Disability Status Scale, Timed 25 Foot Walk and 9-Hole Peg Test scales and quality of life, treatment satisfaction, and healthcare resource utilization, measured through the MSIS-29, TSQM 1.4, and EQ-5D-3L scales, respectively. MRI lesions will be compared in the exploratory setting between the 12-month pre-baseline period, baseline, and at years 1 and 2. Adverse events will be monitored throughout the study. Interim analyses are pre-planned when 30% and 60% of patients will complete the 12-month follow-up visit. Conclusions CLAD CROSS will provide efficacy data on cladribine tablets, used as a follow-up treatment to first-line DMDs in the real-world setting, will further establish its safety profile and will collect information to support pharmacoeconomic studies.
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
口服克拉德滨治疗多发性硬化症患者:一项前瞻性有效性和安全性研究方案
背景近年来,治疗多发性硬化症(MS)的疾病改良疗法的数量有所增加。然而,接受这些药物治疗的患者中,有一部分继续经历复发和疾病进展。克拉屈滨片于2017年被批准用于高活性复发性多发性硬化症,包括一种稀疏的口服治疗,通过减少和随后补充淋巴细胞群来发挥其治疗效果。目的/研究样本在这里,我们描述了CLAD CROSS的设计,这是一项前瞻性、非介入性、多中心、IV期研究,针对确诊为RRMS的患者,这些患者在常规临床实践中从一线疾病改善药物(DMD)转为使用克拉屈滨片治疗。242名成年患者将在61个地点(6个国家)招募,为期30个月,并将根据治疗医生的决定,在服用克拉屈滨片后随访2年。研究设计主要终点是基线前12个月和研究结束前12个月中年化复发率(ARR)的变化。次要终点是研究结束时残疾进展或改善6个月的患者百分比,分别通过扩展残疾状态量表、定时25英尺步行和9孔钉测试量表测量,以及通过MSIS-29、TSQM 1.4和EQ-5D-3L量表测量的生活质量、治疗满意度和医疗资源利用率。将在探索性环境中比较基线前12个月、基线以及第1年和第2年的MRI病变。将在整个研究过程中监测不良事件。当30%和60%的患者将完成12个月的随访时,中期分析是预先计划的。结论CLAD CROSS将提供克拉屈滨片的疗效数据,该片在现实世界中用作一线DMD的后续治疗,将进一步建立其安全性,并将收集信息以支持药物经济学研究。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 去求助
来源期刊
CiteScore
6.90
自引率
0.00%
发文量
39
审稿时长
8 weeks
期刊最新文献
Letter re: Aseptic pleocytosis can only be classified as a phenotypic manifestation of MNGIE after exclusion of all differential causes. Decompressive craniectomy versus craniotomy for acute subdural hematoma: A systematic review and meta-analysis with an adjusted subgroup analysis. Hemorrhagic stroke in children. Measurement of cerebral venous oxygenation with quantitative susceptibility mapping after subarachnoid hemorrhage: A pilot study. Best supportive care for patients with primary progressive multiple sclerosis (PPMS) in Germany prior to ocrelizumab treatment: Final results from the RETRO PPMS study.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1