Bosentan in Systemic Sclerosis (HOME)
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.
|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|
- 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.
- 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.
|Study Start Date:||March 2011|
|Study Completion Date:||December 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
2 tablets of 62.5 mg a day from baseline to week 4, then 2 tablets of 125 mg per day to week 12.
|Amsterdam, Netherlands, 10811HV|
|Groningen, Netherlands, 9700RB|
|Leeuwarden, Netherlands, 8934AD|
|Leiden, Netherlands, 2333ZA|
|Maastricht, Netherlands, 6229HX|
|UMC St Radboud|
|Nijmegen, Netherlands, 6525GA|
|Rotterdam, Netherlands, 3015CE|
|Rotterdam, Netherlands, 3078HT|
|Sint Franciscus Gasthuis|
|Rotterdam, Netherlands, 3045PM|
|Zwolle, Netherlands, 8011JW|