Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma
NCT ID: NCT00704665
Last Updated: 2008-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
231 participants
INTERVENTIONAL
1998-12-31
2001-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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2
Placebo
Relaxin
Placebo
A
10ug/kg/day or 25/ug/kg/day
Relaxin
10 ug/kg/day or 25 ug/kg/day
Interventions
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Relaxin
10 ug/kg/day or 25 ug/kg/day
Relaxin
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
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University of California, Los Angeles
OTHER
Boston University
OTHER
University of Chicago
OTHER
UConn Health
OTHER
Johns Hopkins University
OTHER
University of Pittsburgh
OTHER
Medical University of South Carolina
OTHER
Stanford University
OTHER
Georgetown University
OTHER
University of California, San Diego
OTHER
Wayne State University
OTHER
University of Colorado, Denver
OTHER
Medical College of Wisconsin
OTHER
University of Medicine and Dentistry of New Jersey
OTHER
Responsible Party
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UMDNJ
Other Identifiers
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2773
Identifier Type: -
Identifier Source: org_study_id