Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma

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.

Conditions

• Systemic Sclerosis

Interventions

DRUG

Relaxin

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

DRUG

Relaxin

Placebo

Sponsors & Collaborators

• University of California, Los Angeles

  collaborator OTHER

• Boston University

  collaborator OTHER

• University of Chicago

  collaborator OTHER

• UConn Health

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• Stanford University

  collaborator OTHER

• Georgetown University

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• Wayne State University

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• Medical College of Wisconsin

  collaborator OTHER

• University of Medicine and Dentistry of New Jersey

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1998-12-31

Primary Completion

2001-12-31

Completion

2001-12-31