Effects of bosentan in a homogeneous population of SSc subjects with a predefined restriction of blood flow in the hands
- Conditions
- Systemic Connective Tissue DiseaseSystemic Scleroderma100107611004704310003216
- Registration Number
- NL-OMON36236
- Lead Sponsor
- Actelion Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 106
1. Male and female subjects > 18 years diagnosed with systemic sclerosis;
2. Reduction of blood flow measured by laser Doppler imaging, of at least 50%, distally to the proximal interphalangeal joint, compared to historical healthy controls;
3. Women of childbearing potential must have a negative pregnancy test and use a reliable form of contraception;
4. A history of 1 or more DUs within 2 years prior to inclusion;
5. No use of bosentan in the past;
6. Subjects willing and able to sign informed consent.
1. Parenteral Prostanoid treatment for DU < 3 months ago;
2. Chronic treatment with PDE-5 inhibitor or ERA;
3. History of bosentan use;
4. Irreversible significant limitation of the hand function, e.g. amputation of more than one finger;
5. Other types of system- or connective tissue diseases;
6. Significant peripheral (macro-) vascular disease due to e.g. diabetes, hyperlipidemia, uncontrolled systemic hypertension, coagulopathy;
7. Any serious medical co morbidity (eg, active malignancy) such that the subjects life expectancy is < 12 months;
8. Known AST and/or ALT elevations higher than 3 times Upper Limit Normal (ULN);
9. Moderate to severe liver function disorder;
10. Pregnancy or breastfeeding;
11. Treatment with Glibenclamide, Fluconazole, Cyclosporin A, Tacrolimus or other calcineurin inhibitors;
12. Hypersensitivity for bosentan or one of its components;
13. Subjects not able to follow the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Relationship between blood flow in the hands, as measured by laser Doppler<br /><br>imaging, and extent of digital ulcera assessed by the mean blood flow<br /><br>restriction in four distinct groups of patients: patients without current<br /><br>digital ulcera (pitting scars allowed), patients with new digital ulcera (less<br /><br>than 3 months old), patients with persistent digital ulcera (more than 3 months<br /><br>old) and patients with significant tip-necrosis;<br /><br><br /><br>- Change in blood flow in the hands after 12 weeks of bosentan treatment<br /><br>compared to the blood flow at 0 weeks, as measured by laser Doppler imaging.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Change in blood flow in different regions of the hands after 4 and 12 weeks<br /><br>of bosentan treatment compared to the blood flow after 0 weeks, as measured by<br /><br>laser Doppler imaging;<br /><br><br /><br>- Change in modified Rodnan Skin Score (mRSS) from 0 weeks to 12 weeks, 26<br /><br>weeks and 52 weeks of bosentan treatment;<br /><br><br /><br>- Change in selected components of the Scleroderma Health Assessment<br /><br>Questionnaire from 0 weeks to 12 weeks, 26 weeks and 52 weeks of bosentan<br /><br>treatment;<br /><br><br /><br>- Changes in EQ 5D from 0 weeks to 12 weeks, 26 weeks and 52 weeks of bosentan<br /><br>treatment;<br /><br><br /><br>- Total number of new DU and pitting scars developed from 0 weeks to 12 weeks,<br /><br>26 weeks and 52 weeks of bosentan treatment.</p><br>