IL-1 TRAP ADMINISTERED SUB-CUTANEOUSLY IN SUBJECTS W RELAPSING POLYMALGIA

IL-1 陷阱在复发性多发性痛症受试者中皮下给药

• 批准号: 7606282
• 负责人: Peter A Merkel
• 金额: $ 0.24万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-01-03 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606282
• 关键词: Antibodies; Clinical; Computer Retrieval of Information on Scientific Projects Database; Dose; Double-Blind Method; Funding; Grant; Institution; Interleukin-1; Label; Laboratories; Measurement; Pharmaceutical Preparations; Phase; Placebo Control; Placebos; Polymyalgia Rheumatica; Randomized; Relapse; Research; Research Personnel; Resources; Safety; Site; Source; Subcutaneous Injections; United States National Institutes of Health; Week; base; day

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This will be a two-week, multi-center, randomized, double-blind, placebo-controlled, parallel group study of IL-1 Trap in subjects with relapsing polymyalgia rheumatica. There will be an Open-Label extension phase allowing subjects to receive subcutaneous injections of 320 mg IL-1 Trap weekly for 24 weeks. The study will be conducted in approximately 12 sites in the US. Approximately 40 subjects willbe randomized in a 1:1 ratio to receieve 320 mg of IL-1 Trap or placebo administered subcutaneously. Subjects will receive a total of three doses of study drug on Days 0, 3, and 7 during the two-week Double-Blind phase. There will be no dose escalation within treatment groups. Subjects will be evaluated for efficacy and safety on a regular basis with clinical observations and laboratory measurements including anti-IL trap antibodies, hs-CRP and ESR. Following completion of the primary 2-week double-blind treatment phase, all subjects will be eligible to receive subcutaneous injections of IL-1 Trap 320 mg every week in an Open-Label safety extension phase for an additional 24 weeks.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这将是为期两周的多中心，随机，双盲的，安慰剂对照，平行组研究IL-1陷阱中的IL-1陷阱。将有一个开放标签的延伸阶段，允许受试者每周接受320 mg IL-1诱捕的皮下注射24周。该研究将在美国大约12个地点进行。 大约40名受试者将以1：1的比率随机分配，以皮下接收320 mg的IL-1陷阱或安慰剂。在为期两周的双盲阶段，受试者将在第0、3和7天接受三剂研究药物。治疗组内将没有剂量升级。将定期评估受试者的功效和安全性，并通过临床观察和实验室测量（包括抗IL TRAP抗体，HS-CRP和ESR）进行评估。 主要2周双盲治疗阶段完成后，所有受试者均有资格在开放标签的安全延伸阶段每周在皮下注射IL-1 TRAP 320毫克，额外24周。