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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 November 2016
• Main ID: NCT00077584
• Date of registration: 10/02/2004
• Prospective Registration: No
• Primary sponsor: Actelion
• Public title: Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma RAPIDS-2
• Scientific 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
• Date of first enrolment: October 2003
• Target sample size: 188
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00077584
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Canada, United States

Contacts

• Name: James Seibold, MD
• Affiliation: Robert Wood Johnson Medical School, New Brunswick, NJ, USA

Key inclusion & 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Systemic Sclerosis

Digital Ulcers

Intervention(s)

Drug: Bosentan 62.5 mg

Drug: Bosentan 125 mg

Drug: Placebo

Primary Outcome(s)

Total number of new digital ulcers per patient up to Week 24 [Time Frame: 24 weeks]

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]

Secondary Outcome(s)

Change from baseline to Week 24 in hand disability [Time Frame: Baseline and Week 24]

Change from baseline to Week 24 in hand pain [Time Frame: Baseline and Week 24]

Proportion of subjects with liver function abnormalities [Time Frame: Every 4 weeks up to Week 24]

Proportion of subjects with treatment-emergent adverse events [Time Frame: up to 32 weeks (8 week post-treatment follow-up)]

Secondary ID(s)

AC-052-331

Source(s) of Monetary Support

Please refer to primary and secondary sponsors