Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma

Systemic Sclerosis Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Trial of Recombinant Human Relaxin in the Treatment of Systemic Sclerosis With Diffuse Scleroderma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00704665
• Other study ID #: 2773
• Status: Completed
• Phase: Phase 3
• First received: June 23, 2008
• Last updated: June 24, 2008
• Start date: December 1998
• Est. completion date: December 2001

Study information

• Verified date: June 2008
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: December 2001
• Est. primary completion date: December 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Drug:
• Relaxin
10 ug/kg/day or 25 ug/kg/day
• Relaxin
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (14)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	Boston University, Georgetown University, Johns Hopkins University, Medical College of Wisconsin, Medical University of South Carolina, Stanford University, University of California, Los Angeles, University of California, San Diego, University of Chicago, University of Colorado, Denver, University of Connecticut Health Center, University of Pittsburgh, Wayne State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRSS		baseline, weeks 4,12, and 24	No
Secondary	HAQ-DI		baseline, weeks 4, 12, and 24	No