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

Primary Purpose

Digital Ulcers, Systemic Sclerosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bosentan 62.5 mg
Bosentan 125 mg
Placebo
Sponsored by
Actelion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Digital Ulcers focused on measuring Scleroderma, Finger Ulcers, Digital Ulcers, Systemic Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Barri Fessler, MD
  • Daniel Furst, MD
  • David Collier, MD
  • Naomi Rothfield, MD
  • Michael Ellman, MD
  • Mittie Doyle, MD
  • Frederick Wigley, MD
  • Joseph Korn, MD
  • Richard Martin, MD
  • Thomas Osborn, MD
  • Vivien Hsu, MD
  • Lee Shapiro, MD
  • Avram Goldberg, MD
  • Bashar Kahaleh, MD
  • Chris Derk, MD
  • Thomas Medsger, MD
  • Edwin Smith, MD
  • Maureen Mayes, MD
  • Jerry Molitor, MD
  • Howard Kenney, MD
  • Mary Ellen Csuka, MD
  • Janet Pope, MD
  • Peter Lee, MD
  • Eric Rich, MD
  • Murray Baron, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bosentan

Placebo

Arm 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

The patients received the matching placebo for 24 weeks

Outcomes

Primary Outcome Measures

Time to complete healing of the cardinal ulcer (CU) up to Week 24 in patients with CU healing maintained for 12 weeks
Total number of new digital ulcers per patient up to Week 24

Secondary Outcome Measures

Change from baseline to Week 24 in hand pain
Pain assessed on visual analog scales
Change from baseline to Week 24 in hand disability
Hand disability indexed assessed using the Health Assessment Questionaire (HAQ)
Proportion of subjects with treatment-emergent adverse events
Proportion of subjects with liver function abnormalities
Increase in aminotransferases

Full Information

First Posted
February 10, 2004
Last Updated
October 26, 2016
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT00077584
Brief Title
Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
May 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digital Ulcers, Systemic Sclerosis
Keywords
Scleroderma, Finger Ulcers, Digital Ulcers, Systemic Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bosentan
Arm Type
Experimental
Arm 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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The patients received the matching placebo for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Bosentan 62.5 mg
Other Intervention Name(s)
Ro 47-0203
Intervention Description
Oral tablets containing 62.5 mg of bosentan
Intervention Type
Drug
Intervention Name(s)
Bosentan 125 mg
Other Intervention Name(s)
Ro 47-0203
Intervention Description
Oral tablets containing 125 mg of bosentan
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablets matching bosentan 62.5-mg tablets and bosentan 125-mg tablets
Primary Outcome Measure Information:
Title
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
Title
Total number of new digital ulcers per patient up to Week 24
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change from baseline to Week 24 in hand pain
Description
Pain assessed on visual analog scales
Time Frame
Baseline and Week 24
Title
Change from baseline to Week 24 in hand disability
Description
Hand disability indexed assessed using the Health Assessment Questionaire (HAQ)
Time Frame
Baseline and Week 24
Title
Proportion of subjects with treatment-emergent adverse events
Time Frame
up to 32 weeks (8 week post-treatment follow-up)
Title
Proportion of subjects with liver function abnormalities
Description
Increase in aminotransferases
Time Frame
Every 4 weeks up to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Seibold, MD
Organizational Affiliation
Robert Wood Johnson Medical School, New Brunswick, NJ, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barri Fessler, MD
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249-7201
Country
United States
Facility Name
Daniel Furst, MD
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1670
Country
United States
Facility Name
David Collier, MD
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Naomi Rothfield, MD
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-1310
Country
United States
Facility Name
Michael Ellman, MD
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Mittie Doyle, MD
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Frederick Wigley, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Joseph Korn, MD
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118-2394
Country
United States
Facility Name
Richard Martin, MD
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Thomas Osborn, MD
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Vivien Hsu, MD
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Lee Shapiro, MD
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Avram Goldberg, MD
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Bashar Kahaleh, MD
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Chris Derk, MD
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Thomas Medsger, MD
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Edwin Smith, MD
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Maureen Mayes, MD
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Jerry Molitor, MD
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Howard Kenney, MD
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Mary Ellen Csuka, MD
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States
Facility Name
Janet Pope, MD
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Peter Lee, MD
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Eric Rich, MD
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Murray Baron, MD
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T1E2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20805294
Citation
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 related to systemic sclerosis: results from the RAPIDS-2 randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2011 Jan;70(1):32-8. doi: 10.1136/ard.2010.130658. Epub 2010 Aug 30.
Results Reference
result
PubMed Identifier
33765691
Citation
Liu C, Chen J, Gao Y, Deng B, Liu K. Endothelin receptor antagonists for pulmonary arterial hypertension. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD004434. doi: 10.1002/14651858.CD004434.pub6.
Results Reference
derived

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

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