Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis

This study has been completed.

First Received on October 18, 1999. Last Updated on 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:	Allocation: Non-Randomized Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: systemic scleroderma

MedlinePlus related topics: Connective Tissue Disorders 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

ClinicalTrials.gov 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, Systemic
Scleroderma, Diffuse
Sclerosis
Connective Tissue Diseases
Skin Diseases
Pathologic Processes
Methocarbamol

Muscle Relaxants, Central
Physiological Effects of Drugs
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012