Clinical trial NCT00848107: Open-Label Study of Oral Treprostinil in Digital Ulcers
Official title: Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: An Open-label Multicenter Extension Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Systemic Sclerosis
Keywords: systemic sclerosis
scleroderma
digital ulcers
vasculopathy
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
First posted: 2009-02-20
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open label extension trial will allow ongoing treatment of subjects who participated in the randomized controlled trials, and will provide long term information about the safety of treprostinil diethanolamine SR in subjects with SSc and digital ulcers.


Eligibility criteria: Inclusion Criteria:

* Eligible subjects who completed assessments for the final visit of the previous TDE-DU-201 controlled trial and who signed appropriate informed consent were eligible to enroll in this extension study.
* If a female of childbearing potential, the subject must have agreed to continue practicing an acceptable method of birth control (i.e., surgical sterilization, approved hormonal contraceptives, barrier methods \[such as a condom or diaphragm\] used with a spermicide, or an intrauterine device).

Exclusion Criteria:

* Have had any change in clinical status that, in the opinion of the Investigator, would pose a safety risk for participation in this extension study;
* Have been found to be unable to complete study assessments in the previous controlled trial;
* Have prematurely discontinued study drug during the previous study due to clinical worsening or treatment related adverse events.

Primary outcomes:
measure: Net Ulcer Burden- Mean Change From Time of Study Entry for Each Scheduled Visit Assessment
timeFrame: Baseline and Months 1, 3, 6, 9, 12, and 18
measure: Total Ulcer Number- Mean Change From Time of Study Entry for Each Scheduled Visit Assessment
timeFrame: Baseline and Months 1, 3, 6, 9, 12, and 18
measure: Formation of New Ulcers
timeFrame: 18 months (or last study visit)
Secondary outcomes:
measure: Patient Function and QOL Measure: Scleroderma Health Assessments Questionnaire (SHAQ)- Mean Change From Study Entry in SHAQ Component Scores at Each Scheduled Assessment
timeFrame: Baseline and Months 1, 3, 6, and 12
measure: Patient Function and Quality of Life Measure: Cochin Hand Function Scale (CHFS)-Mean Change From Study Entry in CHFS Score at Each Scheduled Assessment
timeFrame: Baseline and Months 1, 3, 6, and 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama - Birmingham - Arthritis Clinical Intervention Program
state: Alabama
city: Scottsdale
country: United States
facility: Mayo Clinic Scottsdale
state: Arizona
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Aurora
country: United States
facility: Barbara Davis Centre
state: Colorado
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Washington
country: United States
facility: Georgetown University - Dept. of Medicine/Rheumatology
state: District of Columbia
city: Chicago
country: United States
facility: Northwestern University - Feinberg School of Medicine
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University - Division of Rheumatology
state: Maryland
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan - Scleroderma Program
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: New Brunswick
country: United States
facility: UMDNJ Clinical Research Center
state: New Jersey
city: Lake Success
country: United States
facility: North Shore - LIJ Health System
state: New York
city: New York
country: United States
facility: The Hospital for Special Surgery
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Toledo
country: United States
facility: University of Toledo
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: University of Texas - Houston
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Seattle
country: United States
facility: Virginia Mason Medical
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: London
country: Canada
facility: St Joseph's Health Care
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: London
country: United Kingdom
facility: Royal Free Hospital - Center for Rheumatology
city: Manchester
country: United Kingdom
facility: Salford Royal Hospital
Study officials:
affiliation: Scleroderma Research Consultants LLC
name: James Seibold, MD
role: PRINCIPAL_INVESTIGATOR
References: