Trial | NCT00704665  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    relaxin ...

  • Study Participants

    231
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.
Study Started
Dec 31
1998
Primary Completion
Dec 31
2001
Study Completion
Dec 31
2001
Last Update
Jun 25
2008
Estimate

Drug Relaxin

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

Drug Relaxin

Placebo

2 Placebo Comparator

Placebo

A Experimental

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

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.
No Results Posted