Systemic Sclerosis Clinical Trial
— RAPIDS-2Official 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
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.
Status | Completed |
Enrollment | 188 |
Est. completion date | May 2005 |
Est. primary completion date | March 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Janet Pope, MD | London | Ontario |
Canada | Eric Rich, MD | Montreal | Quebec |
Canada | Murray Baron, MD | Montreal | Quebec |
Canada | Peter Lee, MD | Toronto | Ontario |
United States | Lee Shapiro, MD | Albany | New York |
United States | David Collier, MD | Aurora | Colorado |
United States | Frederick Wigley, MD | Baltimore | Maryland |
United States | Barri Fessler, MD | Birmingham | Alabama |
United States | Joseph Korn, MD | Boston | Massachusetts |
United States | Edwin Smith, MD | Charleston | South Carolina |
United States | Michael Ellman, MD | Chicago | Illinois |
United States | Naomi Rothfield, MD | Farmington | Connecticut |
United States | Richard Martin, MD | Grand Rapids | Michigan |
United States | Maureen Mayes, MD | Houston | Texas |
United States | Daniel Furst, MD | Los Angeles | California |
United States | Avram Goldberg, MD | Manhasset | New York |
United States | Mary Ellen Csuka, MD | Milwaukee | Wisconsin |
United States | Vivien Hsu, MD | New Brunswick | New Jersey |
United States | Mittie Doyle, MD | New Orleans | Louisiana |
United States | Chris Derk, MD | Philadelphia | Pennsylvania |
United States | Thomas Medsger, MD | Pittsburgh | Pennsylvania |
United States | Thomas Osborn, MD | Rochester | Minnesota |
United States | Jerry Molitor, MD | Seattle | Washington |
United States | Howard Kenney, MD | Spokane | Washington |
United States | Bashar Kahaleh, MD | Toledo | Ohio |
Lead Sponsor | Collaborator |
---|---|
Actelion |
United States, Canada,
Matucci-Cerinic M, Denton CP, Furst DE, Mayes MD, Hsu VM, Carpentier P, Wigley FM, Black CM, Fessler BJ, Merkel PA, Pope JE, Sweiss NJ, Doyle MK, Hellmich B, Medsger TA Jr, Morganti A, Kramer F, Korn JH, Seibold JR. Bosentan treatment of digital ulcers re — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to complete healing of the cardinal ulcer (CU) up to Week 24 in patients with CU healing maintained for 12 weeks | 24 weeks | No | |
Primary | Total number of new digital ulcers per patient up to Week 24 | 24 weeks | No | |
Secondary | Change from baseline to Week 24 in hand pain | Pain assessed on visual analog scales | Baseline and Week 24 | No |
Secondary | Change from baseline to Week 24 in hand disability | Hand disability indexed assessed using the Health Assessment Questionaire (HAQ) | Baseline and Week 24 | No |
Secondary | Proportion of subjects with treatment-emergent adverse events | up to 32 weeks (8 week post-treatment follow-up) | Yes | |
Secondary | Proportion of subjects with liver function abnormalities | Increase in aminotransferases | Every 4 weeks up to Week 24 | Yes |
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