Status:
COMPLETED
Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
University of California, Los Angeles
Boston University
Conditions:
Systemic Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2001
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT00704665
Start Date
December 1 1998
End Date
December 1 2001
Last Update
June 25 2008
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.