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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Digital Ulcers; Systemic Sclerosis	Drug: Bosentan 62.5 mg; Drug: Bosentan 125 mg; Drug: Placebo	Phase 3

Study Design

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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

Arms and Interventions

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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	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	Drug: Placebo; Oral tablets matching bosentan 62.5-mg tablets and bosentan 125-mg tablets

Outcome Measures

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Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

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

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.

Contacts and Locations

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  Show 25 Study Locations

Sponsors and Collaborators

Actelion

Investigators

Principal Investigator:	James Seibold, MD	Robert Wood Johnson Medical School, New Brunswick, NJ, USA

More Information

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Publications of Results:

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.

Responsible Party:	Actelion
ClinicalTrials.gov Identifier:	NCT00077584 History of Changes
Obsolete Identifiers:	NCT02800993
Other Study ID Numbers:	AC-052-331
First Posted:	February 11, 2004
Last Update Posted:	October 27, 2016
Last Verified:	October 2016

Keywords provided by Actelion:

Scleroderma; Finger Ulcers; Digital Ulcers; Systemic Sclerosis

Additional relevant MeSH terms:

Sclerosis; Ulcer; Scleroderma, Systemic; Scleroderma, Diffuse; Skin Ulcer; Pathologic Processes	Connective Tissue Diseases; Skin Diseases; Bosentan; Antihypertensive Agents; Endothelin Receptor Antagonists; Molecular Mechanisms of Pharmacological Action