Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma

June 24, 2008 updated by: University of Medicine and Dentistry of New Jersey

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

231

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: Relaxin
10 ug/kg/day or 25 ug/kg/day
Drug: Relaxin
Placebo
Experimental: A
10ug/kg/day or 25/ug/kg/day
Drug: Relaxin
10 ug/kg/day or 25 ug/kg/day
Drug: Relaxin
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MRSS
Time Frame: baseline, weeks 4,12, and 24
baseline, weeks 4,12, and 24

Secondary Outcome Measures

Outcome Measure
Time Frame
HAQ-DI
Time Frame: baseline, weeks 4, 12, and 24
baseline, weeks 4, 12, and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Dentistry of New Jersey

Collaborators

Boston University
Medical University of South Carolina
Johns Hopkins University
University of Colorado, Denver
University of California, San Diego
University of California, Los Angeles
Georgetown University
University of Chicago
Wayne State University
University of Pittsburgh
Medical College of Wisconsin
Stanford University
UConn Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1998

Primary Completion (Actual)

December 1, 2001

Study Completion (Actual)

December 1, 2001

Study Registration Dates

First Submitted

June 23, 2008

First Submitted That Met QC Criteria

June 24, 2008

First Posted (Estimate)

June 25, 2008

Study Record Updates

Last Update Posted (Estimate)

June 25, 2008

Last Update Submitted That Met QC Criteria

June 24, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2773

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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