Roche Pharma AG, Emil-Barell-Straße 1, 79639, Grenzach-Wyhlen, Germany.
F. Hoffmann-La Roche Ltd, Grenzacherstraße 124, 4070, Basel, Switzerland.
BMC Neurol. 2020 Mar 14;20(1):95. doi: 10.1186/s12883-020-01667-7.
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.
多发性硬化症（MS）是一种需要终身治疗的慢性疾病。需要一种高效的药物，不仅对复发形式有效，而且对具有良好安全性特征的进行性 MS 形式也有效，以进一步改善整体患者预后。奥瑞珠单抗是一种针对表达 CD20 的 B 细胞的人源化单克隆抗体，是第一种用于治疗成人复发型多发性硬化症（RMS）和原发性进展型多发性硬化症（PPMS）的药物。其安全性和有效性尚未在大型真实环境中进行研究。CONFIDENCE 旨在进一步描述奥瑞珠单抗在常规临床实践中的安全性概况。此外，将收集真实世界的有效性数据，以补充关键临床试验中记录的疗效数据。
CONFIDENCE 是一项非干预性、前瞻性、多中心、长期研究，从 3000 名新接受奥瑞珠单抗治疗的 RMS 和 PPMS 患者和 1500 名新接受其他选定的多发性硬化症疾病修正治疗（DMT）的患者中收集主要数据。治疗必须符合当地标签并遵循常规实践。数据将在德国约 250 个神经科中心和诊所收集。从 2018 年 4 月开始，招募期为 30 个月。每位患者的观察期计划为 7.5 至 10 年，具体取决于纳入日期，无论患者是否停止治疗。就诊遵循常规实践，并将每 6 个月左右记录一次。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、非干预性、上市后安全性研究，评估奥瑞珠单抗和其他 DMT 在真实环境中的长期安全性和有效性。CONFIDENCE 收集的数据也将纳入为满足国际监管要求而开发的研究中。
