Skip to main content
OpenTrials
Completed

NCT Number: NCT00704665

Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Systemic Sclerosis Connective Tissue Diseases Scleroderma, Diffuse Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

relaxin

Drug

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

Primary outcomes

  1. MRSS

    Time frame: baseline, weeks 4,12, and 24

Secondary outcomes

  1. HAQ-DI

    Time frame: baseline, weeks 4, 12, and 24

Sponsors and collaborators

Lead sponsor

University of Medicine and Dentistry of New Jersey

Other

Collaborators

  • Boston University
  • Georgetown University
  • Johns Hopkins University
  • Medical College of Wisconsin
  • Medical University of South Carolina
  • Stanford University
  • UConn Health
  • University of California, Los Angeles
  • University of California, San Diego
  • University of Chicago
  • University of Colorado, Denver
  • University of Pittsburgh
  • Wayne State University

Registry information

Official study title

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

Important dates

Study start
1998
Primary completion
2001
Study completion
2001
First posted
Jun 25, 2008
Registry last updated
Jun 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.