Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma

University of Medicine and Dentistry of New Jersey231 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

231

Conditions

Systemic Sclerosis

Interventions

RelaxinDRUG

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

RelaxinDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

MRSS

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

Secondary Outcomes

HAQ-DI

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

Data from ClinicalTrials.gov

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