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Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma

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ClinicalTrials.gov Identifier: NCT00704665
Recruitment Status : Completed
First Posted : June 25, 2008
Last Update Posted : June 25, 2008
Sponsor:
Collaborators:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Systemic Sclerosis Drug: Relaxin Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 231 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial of Recombinant Human Relaxin in the Treatment of Systemic Sclerosis With Diffuse Scleroderma
Study Start Date : December 1998
Primary Completion Date : December 2001
Study Completion Date : December 2001


Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. MRSS [ Time Frame: baseline, weeks 4,12, and 24 ]

Secondary Outcome Measures :
  1. HAQ-DI [ Time Frame: baseline, weeks 4, 12, and 24 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
More Information

Responsible Party: James R. Seibold, UMDNJ
ClinicalTrials.gov Identifier: NCT00704665     History of Changes
Other Study ID Numbers: 2773
First Posted: June 25, 2008    Key Record Dates
Last Update Posted: June 25, 2008
Last Verified: June 2008

Keywords provided by Rutgers, The State University of New Jersey:
Diffuse Scleroderma
Skin score

Additional relevant MeSH terms:
Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Methocarbamol
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents