Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma

Phase 3

Completed

• Conditions: Systemic Sclerosis
• Interventions: Drug: Relaxin

• Registration Number: NCT00704665
• Lead Sponsor: University of Medicine and Dentistry of New Jersey

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-12
• Primary Completion: 2001-12
• Study Completion: 2001-12
• Status Verified: 2008-06
• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-06-24
• Last Update Submitted: 2008-06-24
• Study First Posted: 2008-06-25
• Last Update Posted: 2008-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

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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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Relaxin	Placebo
A	Relaxin	10ug/kg/day or 25/ug/kg/day

Primary Outcome Measures

Name	Time	Method
MRSS	baseline, weeks 4,12, and 24

Secondary Outcome Measures

Name	Time	Method
HAQ-DI	baseline, weeks 4, 12, and 24