Systemic Sclerosis
Conditions
Keywords
Diffuse Scleroderma, Skin score
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.
Interventions
DRUGRelaxin
10 ug/kg/day or 25 ug/kg/day
Sponsors
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
University of Medicine and Dentistry of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRSS | baseline, weeks 4,12, and 24 |
Secondary
| Measure | Time frame |
|---|---|
| HAQ-DI | baseline, weeks 4, 12, and 24 |
Outcome results
None listed