Bosentan in Systemic Sclerosis (HOME)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01395732
First received: July 6, 2011
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

The effect of bosentan on digital ulcers (DU) was studied in two randomized placebo-controlled trials (RAPIDS-1 and RAPIDS-2). A limitation of these studies was the heterogeneous study population. More importantly, there were no endpoints that assessed changes in vasculopathy and / or perfusion. Laser Doppler imaging has been shown to effectively demonstrate blood flow restrictions in the hands of patients with Systemic Sclerosis (SSc). The relation between blood flow restriction in the hands measured by laser Doppler imaging and the extent of DU disease has not been studied. The current study will attempt to demonstrate this relation. In addition, the impact of bosentan on the blood flow in the hands, in a defined cohort of SSc-DU patients with a history of DU within the past 2 years and a clinically relevant reduction of blood flow in the hands, will be assessed.


Condition Intervention Phase
Systemic Sclerosis
Digital Ulcers
Drug: Bosentan
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Bosentan in a Homogenous Population of Systemic Sclerosis Subjects With a Predefined Restriction of Blood Flow in the Hands

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Mean blood flow restriction in patients [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Relationship between blood flow in the hands, as measured by laser Doppler imaging, and extent of Digital Ulcer disease assessed by the mean blood flow restriction in four distinct groups of patients: patients without current Digital Ulcers (pitting scars allowed), patients with new Digital Ulcers (< 3 months), patients with persistent Digital Ulcers (> 3 months) and patients with significant tip-necrosis.


Secondary Outcome Measures:
  • Change in blood flow in the hands [ Time Frame: Baseline to 12 weeks of bosentan treatment ] [ Designated as safety issue: No ]
    Change in blood flow in the hands after 12 weeks of bosentan treatment compared to the baseline, as measured by laser Doppler imaging.


Enrollment: 18
Study Start Date: March 2011
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Bosentan
2 tablets of 62.5 mg a day from baseline to week 4, then 2 tablets of 125 mg per day to week 12.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects > 18 years diagnosed with SSc;
  • Reduction of blood flow measured by laser Doppler imaging, of at least 50%, distally to the proximal interphalangeal joint, compared to the healthy volunteers;
  • Women of childbearing potential must have a negative pregnancy test and use a reliable form of contraception;
  • A history of 1 or more DUs within 2 years prior to inclusion;
  • No use of bosentan in the past;
  • Subjects willing and able to sign informed consent.

Exclusion Criteria:

  • Parenteral prostanoid treatment for DU < 3 months ago;
  • Chronic treatment with PDE-5 inhibitor or ERA;
  • History of bosentan use
  • Irreversible significant limitation of the hand function, e.g. amputation of more than one finger;
  • Other types of system- or connective tissue diseases;
  • Significant peripheral (macro-) vascular disease due to e.g. diabetes, hyperlipidemia, uncontrolled systemic hypertension, coagulopathy;
  • Any serious medical co morbidity (eg, active malignancy) such that the subjects life expectancy is < 12 months;
  • Known AST and/or ALT elevations higher than 3 times Upper Limit Normal (ULN);
  • Moderate to severe liver function disorder;
  • Pregnancy or breastfeeding;
  • Treatment with Glibenclamide, Fluconazole, Cyclosporin A, Tacrolimus or other calcineurin inhibitors;
  • Hypersensitivity for bosentan or one of its components;
  • Subjects not able to follow the protocol.
  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 ClinicalTrials.gov identifier: NCT01395732

Locations
Netherlands
VUmc
Amsterdam, Netherlands, 10811HV
UMC Groningen
Groningen, Netherlands, 9700RB
MCL
Leeuwarden, Netherlands, 8934AD
LUMC
Leiden, Netherlands, 2333ZA
MUMC
Maastricht, Netherlands, 6229HX
UMC St Radboud
Nijmegen, Netherlands, 6525GA
Erasmus MC
Rotterdam, Netherlands, 3015CE
Maasstad Ziekenhuis
Rotterdam, Netherlands, 3078HT
Sint Franciscus Gasthuis
Rotterdam, Netherlands, 3045PM
Isala Klinieken
Zwolle, Netherlands, 8011JW
Sponsors and Collaborators
Actelion
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01395732     History of Changes
Other Study ID Numbers: AC-052-427
Study First Received: July 6, 2011
Last Updated: January 6, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Independent Ethics Committee

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Ulcer
Connective Tissue Diseases
Skin Diseases
Pathologic Processes
Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014