Does therapy with bosentan tablets have positive effects on the stiffness of the vessels in patients with scleroderma who have ulcers of the fingers of toes?

• Conditions: Systemic sclerosis (SSc) is characterized by skin fibrosis and visceral disease, mainly of the lungs, kidneys and the heart, accompanied by microvascular damage ultimately leading to digital ischemia. Digital ischaemia, digital ulceration (DU) or amputation are well-known manifestations of SSc. Still over 50% of the SSc patients suffer from DU. Despite effort and treatment modalities that have emerged, DU remain an important complication in SSc, even in those with mild disease.; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-002796-28-NL
• Lead Sponsor: niversity Medical Center Groningen (UMCG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-23
• Last Update Posted: 18 April 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 18 years or older
• Systemic sclerosis based on the 2013 ACR/EULAR criteria
• Raynaud’s phenomenon (RP)
• A history of digital ulcer disease
• Assessable Pulse Wave Velocity (PWV) measurement at baseline
• Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Hypersensitivity to the active substance or to any of the excipients
• Moderate to severe hepatic impairment, i.e., Child-Pugh class B or C
• Baseline values of liver aminotransferases, i.e., aspartate
aminotransferases (AST) and/or alanine aminotransferases (ALT), greater
than 3 times the upper limit of normal
• Concomitant use of cyclosporine A
• Pregnancy
• Women of child-bearing potential who are not using reliable methods of
contraception
• Significant peripheral vascular disease as the sole consequence of
atherosclerotic disease due to for example diabetes, dyslipidemia,
systemic hypertension, coagulopathy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified