Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis

National Center for Research Resources (NCRR)

Status and phase: Completed; Phase 2

Conditions: Systemic Sclerosis

Treatments: Drug: relaxin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004380

SUMC-37488

199/12015

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Progressive systemic sclerosis (scleroderma)
• No pregnant or nursing women