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OpenTrials
Completed

NCT Number: NCT00077584

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

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.

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Key information

Conditions

Digital Ulcers Connective Tissue Diseases Scleroderma, Diffuse Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases Systemic Sclerosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bosentan 62.5 mg

Drug

Oral tablets containing 62.5 mg of bosentan

Other names: Ro 47-0203

Bosentan 125 mg

Drug

Oral tablets containing 125 mg of bosentan

Other names: Ro 47-0203

Placebo

Drug

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

Primary outcomes

  1. 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

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

    Time frame: 24 weeks

Secondary outcomes

  1. Change from baseline to Week 24 in hand pain

    Time frame: Baseline and Week 24

    Pain assessed on visual analog scales

  2. Change from baseline to Week 24 in hand disability

    Time frame: Baseline and Week 24

    Hand disability indexed assessed using the Health Assessment Questionaire (HAQ)

  3. Proportion of subjects with treatment-emergent adverse events

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

  4. Proportion of subjects with liver function abnormalities

    Time frame: Every 4 weeks up to Week 24

    Increase in aminotransferases

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study 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

Acronym: RAPIDS-2

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Feb 11, 2004
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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