Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma

Actelion188 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

188

Conditions

Digital Ulcers Systemic Sclerosis

Interventions

Bosentan 62.5 mgDRUG

Oral tablets containing 62.5 mg of bosentan

Bosentan 125 mgDRUG

Oral tablets containing 125 mg of bosentan

PlaceboDRUG

Oral tablets matching bosentan 62.5-mg tablets and bosentan 125-mg tablets

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Time to complete healing of the cardinal ulcer (CU) up to Week 24 in patients with CU healing maintained for 12 weeks

Time frame: 24 weeks

Total number of new digital ulcers per patient up to Week 24

Time frame: 24 weeks

Secondary Outcomes

Change from baseline to Week 24 in hand pain

Pain assessed on visual analog scales

Time frame: Baseline and Week 24

Change from baseline to Week 24 in hand disability

Hand disability indexed assessed using the Health Assessment Questionaire (HAQ)

Time frame: Baseline and Week 24

Proportion of subjects with treatment-emergent adverse events

Time frame: up to 32 weeks (8 week post-treatment follow-up)

Proportion of subjects with liver function abnormalities

Increase in aminotransferases

Time frame: Every 4 weeks up to Week 24

Data from ClinicalTrials.gov

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