Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis

This study has been completed.

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Collaborators:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Stanford University
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004380

Purpose

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized

Resource links provided by NLM:

MedlinePlus related topics: Scleroderma

Drug Information available for: Methocarbamol Relaxin

U.S. FDA Resources

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Progressive systemic sclerosis (scleroderma)
No pregnant or nursing women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004380

Sponsors and Collaborators

National Center for Research Resources (NCRR)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Stanford University

Investigators

Study Chair:

G. Scott Herron

Stanford University

More Information

No publications provided

Study ID Numbers:	199/12015, SUMC-37488
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004380 History of Changes
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:

Pathologic Processes
Skin Diseases
Connective Tissue Diseases

Scleroderma, Diffuse
Sclerosis
Scleroderma, Systemic

ClinicalTrials.gov processed this record on November 27, 2009