Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma

This study has been completed.
Sponsor:
Collaborators:
University of California, Los Angeles
Boston University
University of Chicago
University of Connecticut Health Center
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
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00704665
First received: June 23, 2008
Last updated: June 24, 2008
Last verified: June 2008
  Purpose

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
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: James R. Seibold, UMDNJ
ClinicalTrials.gov 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, Systemic
Scleroderma, Diffuse
Sclerosis
Connective Tissue Diseases
Skin Diseases
Pathologic Processes
Methocarbamol
Muscle Relaxants, Central
Physiological Effects of Drugs
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014