Digital Ulcers, Systemic Sclerosis
Conditions
Keywords
Scleroderma, Finger Ulcers, Digital Ulcers, Systemic Sclerosis
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.
Interventions
DRUGBosentan 62.5 mg
Oral tablets containing 62.5 mg of bosentan
DRUGBosentan 125 mg
Oral tablets containing 125 mg of bosentan
DRUGPlacebo
Oral tablets matching bosentan 62.5-mg tablets and bosentan 125-mg tablets
Sponsors
Actelion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to complete healing of the cardinal ulcer (CU) up to Week 24 in patients with CU healing maintained for 12 weeks | 24 weeks |
| Total number of new digital ulcers per patient up to Week 24 | 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to Week 24 in hand pain | Baseline and Week 24 | Pain assessed on visual analog scales |
| Change from baseline to Week 24 in hand disability | Baseline and Week 24 | Hand disability indexed assessed using the Health Assessment Questionaire (HAQ) |
| Proportion of subjects with treatment-emergent adverse events | up to 32 weeks (8 week post-treatment follow-up) | — |
| Proportion of subjects with liver function abnormalities | Every 4 weeks up to Week 24 | Increase in aminotransferases |
Outcome results
None listed