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

Purpose

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	Intervention	Phase
Digital Ulcers Systemic Sclerosis	Drug: Bosentan 62.5 mg Drug: Bosentan 125 mg Drug: Placebo	Phase 3


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: systemic scleroderma

MedlinePlus related topics: Scleroderma

Drug Information available for: Bosentan

Genetic and Rare Diseases Information Center resources: Systemic Scleroderma

U.S. FDA Resources

Further study details as provided by Actelion:

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 [ Time Frame: 24 weeks ]
Total number of new digital ulcers per patient up to Week 24 [ Time Frame: 24 weeks ]

Secondary Outcome Measures:

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


Enrollment:	188
Study Start Date:	October 2003
Study Completion Date:	May 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077584

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

Publications:

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
Study First Received:	February 10, 2004
Last Updated:	October 26, 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

ClinicalTrials.gov processed this record on August 22, 2017

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