Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma

This study has been completed.

First Received: June 23, 2008 Last Updated: June 24, 2008 History of Changes

Sponsors and Collaborators:	University of Medicine and Dentistry New Jersey University of California, Los Angeles Boston University University of Chicago University of Connecticut Health Center, Farmington, CT Johns Hopkins University University of Pittsburgh, Pittsburgh, PA Medical University of South Carolina, Charleston, SC Stanford University, Stanford, CA Georgetown University University of California at San Diego, San Diego, CA Wayne State University University of Colorado at Denver and Health Sciences Center Medical College of Wisconsin, Milwaukee, WI
Information provided by:	University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:	NCT00704665

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 III

MedlinePlus related topics: Scleroderma

Drug Information available for: Methocarbamol Relaxin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Trial of Recombinant Human Relaxin in the Treatment of Systemic Sclerosis With Diffuse Scleroderma

Further study details as provided by University of Medicine and Dentistry 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
2: Placebo Comparator Placebo	Drug: Relaxin Placebo
A: Experimental 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

No Contacts or Locations Provided

More Information

No publications provided

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

Keywords provided by University of Medicine and Dentistry New Jersey:

Diffuse Scleroderma
Skin score

Study placed in the following topic categories:

Skin Diseases
Muscle Relaxants, Central
Methocarbamol
Connective Tissue Diseases
Scleroderma

Scleroderma, Diffuse
Sclerosis
Scleroderma, Systemic
Peripheral Nervous System Agents
Diffuse Systemic Sclerosis

Additional relevant MeSH terms:

Skin Diseases
Physiological Effects of Drugs
Sclerosis
Neuromuscular Agents
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses

Methocarbamol
Muscle Relaxants, Central
Connective Tissue Diseases
Scleroderma, Diffuse
Scleroderma, Systemic
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 06, 2009