Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma
- Conditions
- Systemic SclerosisDigital Ulcers
- Interventions
- Registration Number
- NCT00077584
- Lead Sponsor
- Actelion
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 188
- Systemic Sclerosis (SSc), diffuse or limited.
- SSc patients with at least one digital ulcer at baseline qualifying as a cardinal ulcer.
Main
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bosentan Bosentan 125 mg 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 Bosentan Bosentan 62.5 mg 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 Placebo Placebo The patients received the matching placebo for 24 weeks
- Primary Outcome Measures
Name Time Method Total number of new digital ulcers per patient up to Week 24 24 weeks Time to complete healing of the cardinal ulcer (CU) up to Week 24 in patients with CU healing maintained for 12 weeks 24 weeks
- Secondary Outcome Measures
Name Time Method 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 liver function abnormalities Every 4 weeks up to Week 24 Increase in aminotransferases
Proportion of subjects with treatment-emergent adverse events up to 32 weeks (8 week post-treatment follow-up) Change from baseline to Week 24 in hand pain Baseline and Week 24 Pain assessed on visual analog scales
Trial Locations
- Locations (25)
Naomi Rothfield, MD
🇺🇸Farmington, Connecticut, United States
Vivien Hsu, MD
🇺🇸New Brunswick, New Jersey, United States
Frederick Wigley, MD
🇺🇸Baltimore, Maryland, United States
Barri Fessler, MD
🇺🇸Birmingham, Alabama, United States
Daniel Furst, MD
🇺🇸Los Angeles, California, United States
David Collier, MD
🇺🇸Aurora, Colorado, United States
Michael Ellman, MD
🇺🇸Chicago, Illinois, United States
Mittie Doyle, MD
🇺🇸New Orleans, Louisiana, United States
Joseph Korn, MD
🇺🇸Boston, Massachusetts, United States
Thomas Osborn, MD
🇺🇸Rochester, Minnesota, United States
Richard Martin, MD
🇺🇸Grand Rapids, Michigan, United States
Thomas Medsger, MD
🇺🇸Pittsburgh, Pennsylvania, United States
Chris Derk, MD
🇺🇸Philadelphia, Pennsylvania, United States
Avram Goldberg, MD
🇺🇸Manhasset, New York, United States
Lee Shapiro, MD
🇺🇸Albany, New York, United States
Bashar Kahaleh, MD
🇺🇸Toledo, Ohio, United States
Edwin Smith, MD
🇺🇸Charleston, South Carolina, United States
Jerry Molitor, MD
🇺🇸Seattle, Washington, United States
Howard Kenney, MD
🇺🇸Spokane, Washington, United States
Eric Rich, MD
🇨🇦Montreal, Quebec, Canada
Janet Pope, MD
🇨🇦London, Ontario, Canada
Peter Lee, MD
🇨🇦Toronto, Ontario, Canada
Murray Baron, MD
🇨🇦Montreal, Quebec, Canada
Mary Ellen Csuka, MD
🇺🇸Milwaukee, Wisconsin, United States
Maureen Mayes, MD
🇺🇸Houston, Texas, United States