Extension of Combination Therapy for Multiple Sclerosis

多发性硬化症联合治疗的延伸

• 批准号: 8042557
• 负责人: FRED D LUBLIN
• 金额: $ 850万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8042557
• 关键词: Biological Markers; Blinded; Clinical Trials; Collection; Combined Modality Therapy; Consultations; Data Analyses; Double-Blind Method; Enrollment; Funding; Goals; Grant; Interferon-beta; Methods; Multiple Sclerosis; National Institute of Neurological Disorders and Stroke; North America; Outcome Measure; Patients; Placebo Control; Placebos; Protocols documentation; Randomized; Relapse; Research Design; Research Personnel; Schedule; Site; Testing; Therapeutic Agents; arm; base; clinical research site; copolymer 1; follow-up; improved; primary outcome; programs

The CombiRx clinical trial is a randomized, double blind, placebo controlled, multi-center randomized study of the efficacy of combining interferon beta-la (IFN) and glatiramer acetate (GA) compared to either agent alone as primary therapy for relapsing-remitting MS (RR MS). The original funding of this NINDS sponsored project was in November 2003. Initially funding was requested for 40 clinical sites across North America. After funding, and based on consultation with NINDS program staff, the number of planned sites was increased to a target of 80 to improve recruitment. The recruitment goal is 1000 subjects, randomized 50% to combination therapy and 25% to each single therapeutic agent with a matched placebo. This application is for renewal of this grant to complete the follow up of all patients through three years on study protocol. The primary outcome and other outcome measures are unchanged from the original protocol. The extension plan, which is to follow all subjects in their original study arm until the last subject has completed all three years of the study, has been approved by the study DSMB as well as the investigators.

CombiRx临床试验是将干扰素β-la（IFN）和醋酸格拉替雷（GA）组合作为复发-缓解型MS（RR MS）的主要疗法与任一单独药剂相比的功效的随机化、双盲、安慰剂对照、多中心随机化研究。2003年11月，国家土著发展战略赞助的这一项目获得了最初的资金。最初的资金要求在北美的40个临床站点。在获得资金后，并根据与NINDS方案工作人员的协商，计划地点的数量增加到80个，以改善招募工作。招募目标为1000例受试者，随机化50% 25%的患者接受联合治疗，25%的患者接受每种单一治疗药物和匹配的安慰剂。本申请用于更新该补助金，以完成对所有患者的随访，随访时间为研究方案的3年。主要结局和其他结局指标与原始方案相同。研究DSMB和研究者已经批准了扩展计划，即对原始研究组中的所有受试者进行随访，直至最后一例受试者完成所有3年的研究。