TRIAL OF REPEATED DOSES OF LJP 394 IN PATIENTS WITH SYSTEMIC LUPUS ERYTHMATOSUS

在系统性红斑狼疮患者中重复服用 LJP 394 的试验

• 批准号: 6304188
• 负责人: Rosalind Ramsey-Goldman
• 金额: $ 2.05万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6304188
• 关键词: clinical research; clinical trials; drug screening /evaluation; human subject; human therapy evaluation; immunopathology chemotherapy; longitudinal human study; nephritis; oligonucleotides; placebos; systemic lupus erythematosus

The purpose of this study is to determine whether LJP 394 is more effective than placebo in preventing renal flare in patients with a prior history of lupus renal disease. This multicenter, double-blind, randomized, placebo-controlled study will enroll approximately 400 patients and is composed of three periods: a screening/qualifying period, a double-blind, placebo-controlled treatment period, and a follow-up assessment period. This is an 18 month trial, with patients completing 61 visits.

本研究的目的是确定LJP 394是否比安慰剂更有效地预防既往有狼疮性肾病病史的患者的肾耀斑。 这项多中心、双盲、随机、安慰剂对照研究将入组约400例患者，包括3个阶段：筛选/资格鉴定期、双盲、安慰剂对照治疗期和随访评估期。 这是一项为期18个月的试验，患者完成了61次访视。