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Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis

Primary Purpose

Systemic Sclerosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
relaxin
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Sclerosis focused on measuring arthritis & connective tissue diseases, rare disease, systemic sclerosis

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Progressive systemic sclerosis (scleroderma) No pregnant or nursing women

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 18, 1999
    Last Updated
    June 23, 2005
    Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004380
    Brief Title
    Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2004
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1991 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 1997 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Stanford University

    4. Oversight

    5. Study Description

    Brief Summary
    OBJECTIVES: I. Determine whether parenteral relaxin improves skin tightness, Raynaud's phenomenon, digital morbidity, and digital ulcers in a patient with progressive systemic sclerosis (scleroderma). II. Determine whether relaxin decreases collagen production by fibroblasts in vivo and cultured from skin biopsies.
    Detailed Description
    PROTOCOL OUTLINE: This is a compassionate use study. The patient is treated with subcutaneous injections of recombinant relaxin for approximately 12 months. If clinically indicated, therapy may be extended.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Systemic Sclerosis
    Keywords
    arthritis & connective tissue diseases, rare disease, systemic sclerosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Allocation
    Non-Randomized
    Enrollment
    1 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    relaxin

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    0 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Progressive systemic sclerosis (scleroderma) No pregnant or nursing women
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    G. Scott Herron
    Organizational Affiliation
    Stanford University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis

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