Multiple sclerosis (MS) is a chronic disease that requires lifelong treatment. A highly effective drug not only for relapsing but also for progressive forms of MS with a favorable safety profile is needed to further improve overall patient outcomes. Ocrelizumab, a recombinant humanized monoclonal antibody that selectively targets CD20-expressing B-cells, is the first drug indicated for the treatment of adult patients with relapsing forms of MS (RMS) and primary progressive MS (PPMS). Its safety and effectiveness profile has yet to be studied in a large, real-world setting. CONFIDENCE aims to further characterize the safety profile of ocrelizumab in routine clinical practice. In addition, real-world effectiveness data will be collected to complement the efficacy data documented in the pivotal clinical trials. CONFIDENCE is a non-interventional, prospective, multicenter, long-term study collecting primary data from 3000 RMS and PPMS patients newly treated with ocrelizumab and 1500 patients newly treated with other selected MS disease-modifying therapies (DMTs). Treatment must be in accordance with the local label and follow routine practice. Data will be collected at approximately 250 neurological centers and practices across Germany. The recruitment period of 30 months started in April 2018. The observation period per patient is planned 7.5 to 10 years, depending on the date of inclusion, regardless of whether patients discontinue treatment. Visits follow routine practice and will be documented approximately every 6 months. The primary endpoint is the incidence and type of uncommon adverse events and death. Statistical analyses will be mainly descriptive and exploratory. CONFIDENCE is a large, non-interventional, post-authorization safety study that assesses long-term safety and effectiveness of ocrelizumab and other DMTs in a real-world setting. Data collected in CONFIDENCE will also be integrated into studies that have been developed to fulfil international regulatory requirements.

中文翻译：

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一项非干预性上市后研究的设计，旨在评估ocrelizumab在德国真实世界多发性硬化症队列中的长期安全性和有效性-CONFIDENCE研究方案。

多发性硬化症（MS）是一种需要终生治疗的慢性疾病。需要一种不仅用于复发的高效药物，而且对于具有渐进性的MS并具有良好的安全性的药物，还需要进一步改善总体患者预后的方法。Ocrelizumab是一种选择性靶向表达CD20的B细胞的重组人源化单克隆抗体，是第一种用于治疗复发型MS（RMS）和原发进行性MS（PPMS）的成年患者的药物。它的安全性和有效性特征尚未在大型的实际环境中进行研究。信心旨在进一步表征奥克珠单抗在常规临床实践中的安全性。此外，将收集实际的有效性数据以补充关键临床试验中记录的有效性数据。机密是非介入性的，这是一项前瞻性，多中心，长期研究，收集了来自3000 RMS新近接受ocrelizumab治疗的RMS和PPMS患者以及1500接受其他选定的MS疾病缓解疗法（DMT）的患者的主要数据。治疗必须符合当地标签并遵循常规做法。数据将在德国大约250个神经病学中心和实践中收集。招募期为30个月，于2018年4月开始。根据纳入日期，每位患者的观察期计划为7.5至10年，无论患者是否终止治疗。随访遵循常规做法，大约每6个月记录一次。主要终点是罕见不良事件和死亡的发生率和类型。统计分析将主要是描述性和探索性的。CONFIDENCE是一项大型的非干预性授权后安全性研究，旨在评估在实际环境中ocrelizumab和其他DMT的长期安全性和有效性。在机密中收集的数据也将被整合到为满足国际法规要求而开发的研究中。