NCT00077584

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2004

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

1.4 years

First QC Date

February 10, 2004

Last Update Submit

January 31, 2025

Conditions

Digital UlcersSystemic Sclerosis

Keywords

SclerodermaFinger UlcersDigital UlcersSystemic Sclerosis

Outcome Measures

Primary Outcomes (2)

  • Time to complete healing of the cardinal ulcer (CU) up to Week 24 in patients with CU healing maintained for 12 weeks

    24 weeks

  • Total number of new digital ulcers per patient up to Week 24

    24 weeks

Secondary Outcomes (4)

  • Change from baseline to Week 24 in hand pain

    Baseline and Week 24

  • Change from baseline to Week 24 in hand disability

    Baseline and Week 24

  • Proportion of subjects with treatment-emergent adverse events

    up to 32 weeks (8 week post-treatment follow-up)

  • Proportion of subjects with liver function abnormalities

    Every 4 weeks up to Week 24

Study Arms (2)

Bosentan

EXPERIMENTAL

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

Drug: Bosentan 62.5 mgDrug: Bosentan 125 mg

Placebo

PLACEBO COMPARATOR

The patients received the matching placebo for 24 weeks

Drug: Placebo

Interventions

Bosentan 62.5 mgDRUG

Oral tablets containing 62.5 mg of bosentan

Also known as: Ro 47-0203
Bosentan
Bosentan 125 mgDRUG

Oral tablets containing 125 mg of bosentan

Also known as: Ro 47-0203
Bosentan
PlaceboDRUG

Oral tablets matching bosentan 62.5-mg tablets and bosentan 125-mg tablets

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Systemic Sclerosis (SSc), diffuse or limited.
  • SSc patients with at least one digital ulcer at baseline qualifying as a cardinal ulcer.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 20805294RESULT

  • 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.

    PMID: 33765691DERIVED

MeSH Terms

Conditions

digital ulcersScleroderma, SystemicScleroderma, Diffuse

Interventions

Bosentan

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • James Seibold, MD

    Robert Wood Johnson Medical School, New Brunswick, NJ, USA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2004

First Posted

February 11, 2004

Study Start

October 1, 2003

Primary Completion

March 1, 2005

Study Completion

May 1, 2005

Last Updated

February 3, 2025

Record last verified: 2025-01