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

Systemic Sclerosis Clinical Trial

— RAPIDS-2  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02800993
• Other study ID #: AC-052-331
• Status: Completed
• Phase: Phase 3
• First received: June 13, 2016
• Last updated: June 13, 2016
• Start date: October 2003
• Est. completion date: May 2005

Study information

• Verified date: June 2016
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: SwissmedicUnited States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Italy: The Italian Medicines AgencySpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digital Ulcers
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Skin Ulcer
• Systemic Sclerosis
• Ulcer

Intervention

Drug:
• Bosentan 62.5 mg
Oral tablets containg 62.5 mg of bosentan
• Bosentan 125 mg
Oral tablets containing 125 mg of bosentan
• Placebo
Oral tablets matching bosentan 62.5-mg tablets and bosentan 125-mg tablets

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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

Outcome

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