Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis - Tabular View

Tracking Information

First Received Date ^ICMJE

October 18, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

December 1991

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004380 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis

Official Title ^ICMJE

Brief Summary

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.

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized

Condition ^ICMJE

Systemic Sclerosis

Intervention ^ICMJE

Drug: relaxin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 1997

Primary Completion Date

Eligibility Criteria ^ICMJE

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Progressive systemic sclerosis (scleroderma)
No pregnant or nursing women

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00004380

Responsible Party

Study ID Numbers ^ICMJE

199/12015, SUMC-37488

Study Sponsor ^ICMJE

National Center for Research Resources (NCRR)

Collaborators ^ICMJE

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

Investigators ^ICMJE

Study Chair:

G. Scott Herron

Stanford University

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

July 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP