临床试验/NCT00704665

NCT00704665已完成3 期

A Randomized, Double-Blind, Placebo-Controlled Trial of Recombinant Human Relaxin in the Treatment of Systemic Sclerosis With Diffuse Scleroderma

University of Medicine and Dentistry of New Jersey0 个研究点目标入组 231 人开始时间: 1998年12月最近更新: 2008年6月25日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: University of Medicine and Dentistry of New Jersey
入组人数: 231
主要终点: MRSS

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

Relaxin is a naturally occurring protein prduced by the ovary or placenta in pregnancy. It has ani-fibrotic properties. Previous studies have shown that relaxin is safe at concentrations upto 60 times higher than achieved in pregnancy. Study is designed to see if skin improvement and improvement in functional ability can be achieved.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Men and women 18 to 70 years of age with diffuse SSc
•Disease duration 5 years since the onset of the first non-Raynaud sign or symptom
•A baseline modified Rodnan skin score (MRSS) of 20 or greater, or at least 16 if truncal involvement was present.
•Recombinant human relaxin (10 or 25 ug/kg/day), or placebo was administered for 24 weeks as a continuous subcutaneous infusion and there was a follow-up safety visit at week 28.

排除标准

未提供

研究组 & 干预措施

2

Placebo Comparator

Placebo

干预措施: Relaxin (Drug)

A

Experimental

10ug/kg/day or 25/ug/kg/day

干预措施: Relaxin (Drug)

结局指标

主要结局

MRSS

时间窗: baseline, weeks 4,12, and 24

次要结局

HAQ-DI(baseline, weeks 4, 12, and 24)

研究者

发起方

University of Medicine and Dentistry of New Jersey

申办方类型

Other

相似试验

已完成

2 期

Efficacy and Safety of Relaxin for the Treatment of Acute Heart FailureHeart Failure, Congestive

NCT00520806Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies1,161

已完成

1 期

A Study to Evaluate the Efficacy of ELAPR in Women With Striae Distensae AlbaStriae Distensae

NCT02510768Elastagen Pty Ltd26

已完成

不适用

A Study to Evaluate the Efficacy of ELAPR002f in Females and Males With Atrophic Acne ScarsAtrophic Acne Scar

NCT03056235Elastagen Pty Ltd30

已完成

2 期

Phase II Study of Recombinant Relaxin for Progressive Systemic SclerosisSystemic Sclerosis

NCT00004380National Center for Research Resources (NCRR)1

终止

3 期

A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4)Recurrent C. Difficile Infection

NCT05153499Finch Research and Development LLC.19