Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma (RAPIDS-2)
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ClinicalTrials.gov Identifier: NCT00077584 |
Recruitment Status :
Completed
First Posted : February 11, 2004
Last Update Posted : October 27, 2016
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Condition or disease | Intervention/treatment | Phase |
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Digital Ulcers Systemic Sclerosis | Drug: Bosentan 62.5 mg Drug: Bosentan 125 mg Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 188 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | October 2003 |
Actual Primary Completion Date : | March 2005 |
Actual Study Completion Date : | May 2005 |

Arm | Intervention/treatment |
---|---|
Experimental: Bosentan
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
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Drug: Bosentan 62.5 mg
Oral tablets containing 62.5 mg of bosentan
Other Name: Ro 47-0203 Drug: Bosentan 125 mg Oral tablets containing 125 mg of bosentan
Other Name: Ro 47-0203 |
Placebo Comparator: Placebo
The patients received the matching placebo for 24 weeks
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Drug: Placebo
Oral tablets matching bosentan 62.5-mg tablets and bosentan 125-mg tablets |
- 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 ]
- Total number of new digital ulcers per patient up to Week 24 [ Time Frame: 24 weeks ]
- Change from baseline to Week 24 in hand pain [ Time Frame: Baseline and Week 24 ]Pain assessed on visual analog scales
- 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)
- Proportion of subjects with treatment-emergent adverse events [ Time Frame: up to 32 weeks (8 week post-treatment follow-up) ]
- Proportion of subjects with liver function abnormalities [ Time Frame: Every 4 weeks up to Week 24 ]Increase in aminotransferases

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00077584

Principal Investigator: | James Seibold, MD | Robert Wood Johnson Medical School, New Brunswick, NJ, USA |
Responsible Party: | Actelion |
ClinicalTrials.gov Identifier: | NCT00077584 |
Obsolete Identifiers: | NCT02800993 |
Other Study ID Numbers: |
AC-052-331 |
First Posted: | February 11, 2004 Key Record Dates |
Last Update Posted: | October 27, 2016 |
Last Verified: | October 2016 |
Scleroderma Finger Ulcers Digital Ulcers Systemic Sclerosis |
Scleroderma, Systemic Scleroderma, Diffuse Skin Ulcer Sclerosis Ulcer Pathologic Processes |
Connective Tissue Diseases Skin Diseases Bosentan Antihypertensive Agents Endothelin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |