Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis

This study has been completed.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Stanford University
Information provided by:
Office of Rare Diseases (ORD) Identifier:
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: July 2004

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.

Condition Intervention Phase
Systemic Sclerosis
Drug: relaxin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 1
Study Start Date: December 1991
Estimated Study Completion Date: December 1997
Detailed 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.

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


--Disease Characteristics--

  • Progressive systemic sclerosis (scleroderma)
  • No pregnant or nursing women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00004380

Sponsors and Collaborators
National Center for Research Resources (NCRR)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Stanford University
Study Chair: G. Scott Herron Stanford University
  More Information Identifier: NCT00004380     History of Changes
Other Study ID Numbers: 199/12015  SUMC-37488 
Study First Received: October 18, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
arthritis & connective tissue diseases
rare disease
systemic sclerosis

Additional relevant MeSH terms:
Scleroderma, Diffuse
Scleroderma, Systemic
Connective Tissue Diseases
Pathologic Processes
Skin Diseases processed this record on May 26, 2016