Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma (RAPIDS-2)

Actelion Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Systemic Sclerosis; Digital Ulcers

Treatments: Drug: Placebo; Drug: Bosentan 125 mg; Drug: Bosentan 62.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00077584

AC-052-331

Details and patient eligibility

About

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.

Enrollment: 188 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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188 participants in 2 patient groups, including a placebo group

Bosentan

Experimental group

Description:

The patients received bosentan 62.5 mg twice daily (b.i.d.) for 4 weeks and then 125 mg b.i.d. for 20 weeks

Treatment:

Drug: Bosentan 62.5 mg

Drug: Bosentan 125 mg

Placebo

Placebo Comparator group

Description:

The patients received the matching placebo for 24 weeks

Treatment:

Drug: Placebo