CompletedNCT00704665Updated Jun 25, 2008

Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma

A Phase 3 interventional study of Relaxin and Relaxin in Systemic Sclerosis, sponsored by University of Medicine and Dentistry of New Jersey. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2008-06-25.

Sponsored by University of Medicine and Dentistry of New Jersey · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 231
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study 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.

Conditions studied

Systemic Sclerosis

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Keywords

Diffuse Scleroderma
Skin score

In context

Scleroderma, Systemic

688 studies on the registry are indexed under Scleroderma, Systemic; 223 are open to participants now.

This study's enrollment of 231 is above the median of 34 across 493 interventional studies indexed under Scleroderma, Systemic.

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Lead sponsor

University of Medicine and Dentistry of New Jersey is the lead sponsor of 103 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility 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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 231 participants (actual)

Study arms

Placebo comparator
2
Placebo
Drug: Relaxin
Experimental
A
10ug/kg/day or 25/ug/kg/day
Drug: Relaxin

Interventions

DrugRelaxin
10 ug/kg/day or 25 ug/kg/day
DrugRelaxin
Placebo

What researchers measure

Primary outcomes

MRSS
Time frame: baseline, weeks 4,12, and 24

Secondary outcomes

HAQ-DI
Time frame: baseline, weeks 4, 12, and 24

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 25, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00704665
Lead sponsor: University of Medicine and Dentistry of New Jersey
Collaborators: University of California, Los Angeles, Boston University, University of Chicago, UConn Health, 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
First posted: Jun 25, 2008
Start date: Dec 1998
Primary completion: Dec 2001
Completion: Dec 2001
Last update: Jun 25, 2008

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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