Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma

Last updated: June 24, 2008
Sponsor: University of Medicine and Dentistry of New Jersey
Overall Status: Completed

Phase

3

Condition

Scleroderma

Collagen Vascular Diseases

Connective Tissue Diseases

Treatment

N/A

Clinical Study ID

NCT00704665
2773
  • Ages 18-70
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 231
Study Start date:
December 01, 1998
Estimated Completion Date:
December 31, 2001