Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma

• Status: Completed
• Trial end date: 2001-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Medicine and Dentistry of New Jersey
• 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
• Treatments: Methocarbamol

Criteria

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.