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Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma

Primary Purpose

Systemic Sclerosis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Relaxin
Relaxin
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Sclerosis focused on measuring Diffuse Scleroderma, Skin score

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    2

    A

    Arm Description

    Placebo

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

    Outcomes

    Primary Outcome Measures

    MRSS

    Secondary Outcome Measures

    HAQ-DI

    Full Information

    First Posted
    June 23, 2008
    Last Updated
    June 24, 2008
    Sponsor
    University of Medicine and Dentistry of New Jersey
    Collaborators
    University of California, Los Angeles, Boston University, University of Chicago, UConn Health, Johns Hopkins University, University of Pittsburgh, Medical University of South Carolina, Stanford University, Georgetown University, University of California, San Diego, Wayne State University, University of Colorado, Denver, Medical College of Wisconsin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00704665
    Brief Title
    Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma
    Official Title
    A Randomized, Double-Blind, Placebo-Controlled Trial of Recombinant Human Relaxin in the Treatment of Systemic Sclerosis With Diffuse Scleroderma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1998 (undefined)
    Primary Completion Date
    December 2001 (Actual)
    Study Completion Date
    December 2001 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Medicine and Dentistry of New Jersey
    Collaborators
    University of California, Los Angeles, Boston University, University of Chicago, UConn Health, Johns Hopkins University, University of Pittsburgh, Medical University of South Carolina, Stanford University, Georgetown University, University of California, San Diego, Wayne State University, University of Colorado, Denver, Medical College of Wisconsin

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Systemic Sclerosis
    Keywords
    Diffuse Scleroderma, Skin score

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    231 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    10ug/kg/day or 25/ug/kg/day
    Intervention Type
    Drug
    Intervention Name(s)
    Relaxin
    Intervention Description
    10 ug/kg/day or 25 ug/kg/day
    Intervention Type
    Drug
    Intervention Name(s)
    Relaxin
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    MRSS
    Time Frame
    baseline, weeks 4,12, and 24
    Secondary Outcome Measure Information:
    Title
    HAQ-DI
    Time Frame
    baseline, weeks 4, 12, and 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Learn more about this trial

    Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma

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