Clinical trial NCT00077584: Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Digital Ulcers
Systemic Sclerosis
Keywords: Scleroderma
Finger Ulcers
Digital Ulcers
Systemic Sclerosis
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2004-02-11
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In an earlier clinical trial, RAPIDS-1, conducted in scleroderma patients with or without digital ulcers at baseline, bosentan significantly reduced the number of new digital ulcers versus placebo. The purpose of the present trial (RAPIDS-2) is to evaluate the prevention and healing effects of bosentan versus placebo on digital ulcers over a 24-week treatment period.


Eligibility criteria: Main Inclusion Criteria:

* Systemic Sclerosis (SSc), diffuse or limited.
* SSc patients with at least one digital ulcer at baseline qualifying as a cardinal ulcer.

Main Exclusion Criteria:

* Digital ulcers due to conditions other than SSc.
* Severe pulmonary arterial hypertension (PAH) (Who class III and IV).
* Malabsorption or any severe organ failure (e.g., lung, kidney, liver) or any life-threatening condition.
* Treatment with parenteral prostanoids (prostaglandin E, epoprostenol, or prostacyclin analogs) during the past 3 months prior to randomization.
* Treatment with inhaled or oral prostanoids one month prior to randomization.
* Previous treatment with bosentan.

Primary outcomes:
measure: Time to complete healing of the cardinal ulcer (CU) up to Week 24 in patients with CU healing maintained for 12 weeks
timeFrame: 24 weeks
measure: Total number of new digital ulcers per patient up to Week 24
timeFrame: 24 weeks
Secondary outcomes:
measure: Change from baseline to Week 24 in hand pain
timeFrame: Baseline and Week 24
measure: Change from baseline to Week 24 in hand disability
timeFrame: Baseline and Week 24
measure: Proportion of subjects with treatment-emergent adverse events
timeFrame: up to 32 weeks (8 week post-treatment follow-up)
measure: Proportion of subjects with liver function abnormalities
timeFrame: Every 4 weeks up to Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Robert Wood Johnson Medical School, New Brunswick, NJ, USA
name: James Seibold, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matucci-Cerinic M, Denton CP, Furst DE, Mayes MD, Hsu VM, Carpentier P, Wigley FM, Black CM, Fessler BJ, Merkel PA, Pope JE, Sweiss NJ, Doyle MK, Hellmich B, Medsger TA Jr, Morganti A, Kramer F, Korn JH, Seibold JR. Bosentan treatment of digital ulcers related to systemic sclerosis: results from the RAPIDS-2 randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2011 Jan;70(1):32-8. doi: 10.1136/ard.2010.130658. Epub 2010 Aug 30.
citation: Liu C, Chen J, Gao Y, Deng B, Liu K. Endothelin receptor antagonists for pulmonary arterial hypertension. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD004434. doi: 10.1002/14651858.CD004434.pub6.