Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis
OBJECTIVES: I. Determine whether parenteral relaxin improves skin tightness, Raynaud's phenomenon, digital morbidity, and digital ulcers in a patient with progressive systemic sclerosis (scleroderma).
II. Determine whether relaxin decreases collagen production by fibroblasts in vivo and cultured from skin biopsies.
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Treatment
|Study Start Date:||December 1991|
|Estimated Study Completion Date:||December 1997|
PROTOCOL OUTLINE: This is a compassionate use study. The patient is treated with subcutaneous injections of recombinant relaxin for approximately 12 months. If clinically indicated, therapy may be extended.
|Study Chair:||G. Scott Herron||Stanford University|