Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma

This study has been completed.
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Information provided by:
Rutgers, The State University of New Jersey Identifier:
First received: June 23, 2008
Last updated: June 24, 2008
Last verified: June 2008
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 Intervention Phase
Systemic Sclerosis
Drug: Relaxin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • MRSS [ Time Frame: baseline, weeks 4,12, and 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HAQ-DI [ Time Frame: baseline, weeks 4, 12, and 24 ] [ Designated as safety issue: No ]

Enrollment: 231
Study Start Date: December 1998
Study Completion Date: December 2001
Primary Completion Date: December 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
Drug: Relaxin
Experimental: A
10ug/kg/day or 25/ug/kg/day
Drug: Relaxin
10 ug/kg/day or 25 ug/kg/day


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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  More Information

Responsible Party: James R. Seibold, UMDNJ Identifier: NCT00704665     History of Changes
Other Study ID Numbers: 2773 
Study First Received: June 23, 2008
Last Updated: June 24, 2008
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Scleroderma, Diffuse
Scleroderma, Systemic
Connective Tissue Diseases
Pathologic Processes
Skin Diseases
Central Nervous System Agents
Muscle Relaxants, Central
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on May 05, 2016