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Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients (DUAL-2)

Primary Purpose

Digital Ulcers

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Macitentan 3 mg
Macitentan 10 mg
Placebo
Sponsored by
Actelion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Digital Ulcers focused on measuring digital ulcers, systemic sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria :

  • Patients ≥ 18 years of age
  • Women of childbearing potential must use two reliable methods of contraception
  • Diagnosis of SSc according to the classification criteria of the American College of Rheumatology (ACR)
  • At least one visible, active ischemic DU at baseline
  • History of at least one additional recent active ischemic digital ulcer

Exclusion Criteria :

  • DUs due to condition other than SSc
  • Symptomatic pulmonary arterial hypertension (PAH)
  • Body mass index (BMI) < 18 kg/m^2
  • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 x upper limit of normal (ULN)
  • Hemoglobin < 75% of the lower limit of the normal range
  • Systolic blood pressure < 95 mmHg or diastolic blood pressure < 50 mmHg
  • Severe malabsorption; any severe organ failure (e.g., lung, kidney), or any life-threatening condition
  • Females who are pregnant or breastfeeding or plan to do so during the course of this study
  • Substance or alcohol abuse or dependence, or tobacco use at any level
  • Treatment with phosphodiesterase-5 (PDE5) inhibitors
  • Patients on statins, who have received treatment for less than 3 months prior to Screening or whose treatment has not been stable during this period
  • Patients on vasodilators, who have received treatment for less than 2 weeks prior to Screening or whose treatment has not been stable during this period
  • Treatment with prostanoids within 3 months
  • Treatment with disease modifying agents if present for less than 3 months prior to Screening or whose treatment has not been stable for at least 1 month prior to Screening
  • Treatment with oral corticosteroids (> 10 mg/day of prednisone or equivalent).
  • Treatment with endothelin receptor antagonists (ERAs) within 3 months
  • Systemic antibiotics to treat infected DU(s) within 4 weeks

Sites / Locations

  • Stanford Univ. School of Medicine - Palo Alto VA Health Care System
  • University of Connecticut Health Center - Division of Rheumatic Diseases
  • Georgetown University
  • Millennium Research
  • Cleveland Clinic Florida
  • Florida Medical Clinic-PA
  • Northwestern University - Feinberg School of Medicine Department of Rheumatology
  • Boston University School of Medicine
  • Washington University School of Medicine
  • North Shore Long Island Jewish Health System - Div. of Rheumatology & Allergy-Clinical Immunology
  • The Hospital for Special Surgery
  • Ruppert Health Center
  • The University of Pennsylvania
  • University of Texas - Houston Medical School
  • University of Utah
  • Arthritis Northwest PLLC
  • Medical College of Wisconsin
  • Centro de Educacion Medica e Investigaciones Clinicas - CEMIC
  • Hospital Britanico de Buenos Aires
  • Hospital Italiano de Buenos Aires
  • Sanatorio San Jose
  • Hospital Italiano de Cordoba
  • Hospital Privado Centro Medico de Cordoba S.A.
  • Clinique Universitaires Saint Luc
  • Cliniques universitaires UCL Mont-Godinne
  • Peking Union Medical College Hospital
  • Guangdong General Hospital
  • Renji Hospital, Shanghai Jiaotong University
  • First Affiliated Hospital of the Forth Military University
  • Hospital Pablo Tobon Uribe
  • Centro Integral de Reumatologia y Inmunologia CIREI SAS
  • Fundacion Instituto du Reumatologia Fernando Chalem
  • Kerckhoff-Klinik GmbH
  • Universitätsklinikum der Technischen Universität Dresden
  • Hautklinik Universitätsklinikum Erlangen
  • Department of Dermatology University Hospital Johannes Gutenberg
  • Ludwig-Maximilian-Universität München Abteilung Dermatologie
  • Klinik und Poliklinik für Dermatologie und Allergologie am Biderstein des Klinikums rechts der Isar der Technischen Universität München
  • General University Hospital LAIKO/A' Propaideftiki Pathology Clinic
  • EUROMEDICA - Kyanos Stavros
  • General University Hospital AHEPA
  • Cork University Hospital
  • Beaumont Hospital
  • St. Vincents University Hospital
  • Mid-Western Regional Hospital
  • Sheba Medical Center
  • Asaf Harofe Medical Center
  • Unidad de Investigacion en Enfermedades Cronico Degeneratives SC
  • Christus Muguerza del Parque Hospital
  • Clinica Diagnostico y Tratamiento de las Enfermedades Reumaticas
  • Hospital Civil de Guadalajara - Fray Antonio Alacade Hospital No. 278
  • Hospital Aranda de la Parra Leon
  • Hospital Angeles Lindavista
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubrian
  • VU University Medical Center
  • UMC St Radboud
  • Middlemore Hospital
  • Dunedin Hospital
  • Waikato Hospital
  • North Shore Hospital, STAR (Shore Trials and Research) Unit
  • Wellington Hospital
  • Prywatna Praktyka Lekarska Prof. UM dr hab. med. Paweł Hrycaj
  • SPSK Nr 1 PUM Szczecin
  • Reumatika - Centrum Reumatologii NZOZ
  • Wojskowy Instytut Medyczny CSK MON
  • SPSK Nr 1 Wrocław
  • Instituto Português de Reumatologia
  • University of Puerto Rico
  • State Institution, "Institute of Rheumatology of RAMS"
  • Municipal Treatment and Prevention Institution, "City Clinical Hospital #5"
  • State Educational Institution of High Professional Education "Voronezh State Medical Academy named after N.N.Burdenko of Roszdrav"
  • Groote Schuur Hospital, University of Cape Town
  • Louis Pasteur Medical Centre
  • Chris Hani Baragwanath Hospital
  • HOSPITAL Universitario VALL D'HEBRON - Servicio Medicina Interna
  • Hospital Universitari i Politecnic La Fe
  • Çukurova Üniversitesi Tıp Fakültesi ROMATOLOJİ BİLİM DALI
  • Dokuz Eylul Universitesi Tip Fakultesi Romatoloji Bilim Dali
  • Municipal Healthcare Institution "Donetsk Regional Clinical Hospital of Occupational Diseases"
  • National scientific centre "Institute of Cardiology named after M. Strazheska"
  • Crimean Republican Institution 'Clinical territorial medical union 'University Clinic
  • Vinnytsia Regional Clinical Hospital named after M. Pyrogov
  • Scientific and Research Institute of Handicapped Rehabilitation of Vinnitsa National Medical University named after M. Pirogova
  • Royal National Hospital
  • Addenbrooke's Hospital - University of Cambridge School of Clinical Medicine
  • University Hospital Aintree - Rheumatology Department
  • Royal Free & University College Medical School
  • University of Manchester School of Translational Medicine Musculoskeletal Research Group
  • Ninewells Hospital & Medical School
  • Torbay Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Macitentan 3 mg

Macitentan 10 mg

Placebo

Arm Description

Oral macitentan 3 mg, once daily

Oral macitentan 10 mg, once daily

Oral placebo, once daily

Outcomes

Primary Outcome Measures

Incidence Rate of New Digital Ulcers (DUs) up to Week 16
DUs were assessed at each visit starting with the screening visit. Only DUs from the proximal interphalangeal joint (PIP) distally (both on the dorsal and volar surface of the hand, including the digital tip) were recorded. The location of each DU was noted. At each subsequent visit the location of each new DU was noted. DUs that occurred and healed between visits and were reported by patients were not recorded as new DUs. The evaluation was performed by an experienced physician or a trained rater with expertise in the assessment of DUs in systemic sclerosis (SSc). For a given patient, DUs were assessed by the same rater at each visit, whenever possible. Any DU that developed over a previously healed ulcer was recorded as a new DU. Incidence rate is adjusted for 16 weeks of observation, hence is calculated as the number of new DUs/total number of observation days.

Secondary Outcome Measures

Percentage of Participants Without a New DU up to Week 16
DUs were assessed at each visit starting with the screening visit. Only DUs from the proximal interphalangeal joint (PIP) distally (both on the dorsal and volar surface of the hand, including the digital tip) were recorded. The location of each DU was noted. At each subsequent visit the location of each new DU was noted. DUs that occurred and healed between visits and were reported by patients were not recorded as new DUs. The evaluation was performed by an experienced physician or a trained rater with expertise in the assessment of DUs in systemic sclerosis (SSc). For a given patient, DUs were assessed by the same rater at each visit, whenever possible. Any DU that developed over a previously healed ulcer was recorded as a new DU. Numbers of patients with no new DU at Week 16 are imputed using the last observation carried forward method.
Percentage of Participants With at Least One DU Complication
DU complications were defined as any one of the following: resulting from DU worsening: critical ischemic crisis necessitating hospitalization; gangrene, (auto)amputation; failure of conservative management; surgical and chemical sympathectomy, vascular reconstructions, or any unplanned surgery in the management of hand SSc manifestations; use of parenteral prostanoids; use of endothelin-receptor antagonists; class II, III, or IV narcotics or a > 50% increase in the existing dose compared with baseline; initiation of systemic antibiotics for the treatment of infection attributed to DUs.
Change in Hand Functionality Health Assessment Questionnaire - Disability Index (HAQ-DI) Hand Component From Baseline to Week 16
HAQ-DI assesses functional ability regarding fine movements of the upper extremities, locomotor activities in the lower extremities, and movements of the upper and lower limbs. Responses were extracted from the Scleroderma Health Assessment Questionnaire covering 8 domains of functional disability (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities). A mean score ranging from 0-3 was calculated for each domain, and a composite score by dividing the summed domain scores by the number of domains. The composite score was interpreted as 0 (no impairment in function) to 3 (maximal impairment of function). Hand functionality was assessed using a composite of 4 domains (dressing and grooming, grip, hygiene, and eating).
Health Assessment Questionnaire - Disability Index (HAQ-DI) Overall Score From Baseline to Week 16
HAQ-DI assesses functional ability regarding fine movements of the upper extremities, locomotor activities in the lower extremities, and movements of the upper and lower limbs. Responses were extracted from the Scleroderma Health Assessment Questionnaire covering 8 domains of functional disability (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities). A mean score ranging from 0-3 was calculated for each domain, and a composite score by dividing the summed domain scores by the number of domains. The composite score was interpreted as 0 (no impairment in function) to 3 (maximal impairment of function).
Change in Hand Functionality - Hand Disability in Systemic Sclerosis - Digital Ulcers (HDISS-DU) Score From Baseline to Week 16
Patients were asked to answer 24 questions on the use of the hand(s) affected by DUs over the past 7 days on a 6-point scale from 0 (yes without difficulty) to 5 (impossible). The HDISS-DU score is the arithmetic mean of the valid non-missing items. The scores are interpreted as 1 (better ability in completing activities) to 6 (worst ability in completing activities)

Full Information

First Posted
October 31, 2011
Last Updated
November 22, 2016
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT01474122
Brief Title
Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients
Acronym
DUAL-2
Official Title
Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Patients With Ischemic Digital Ulcers Associated With Systemic Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
company decision
Study Start Date
December 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The DUAL-2 study is designed as a multicenter, double-blind two-period study with an initial fixed 16-week Period 1, followed by a Period 2 of variable duration. All patients completing Period 1 continue on their original randomized treatment into Period 2, until the last randomized patient has completed Period 1. Patients are randomized in a 1:1:1 ratio (macitentan 3mg: macitentan 10mg: placebo). The primary objective is to demonstrate the effect of macitentan on the reduction of the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcers (DU). Other objectives include: the evaluation of the efficacy of macitentan on hand functionality and DU burden at Week 16 in SSc patients with ongoing DU disease. the evaluation of the safety and tolerability of macitentan in these patients. the evaluation of the efficacy of macitentan on time to first DU complication during the entire treatment period.
Detailed Description
Recurrent digital ulcers (DU) are a manifestation of vascular disease in patients with systemic sclerosis (SSc), are an important source of morbidity and lead to impaired function in these patients. In this study, we are investigating whether treatment with the endothelin receptor antagonist, macitentan, decreases the development of new digital ulcers in patients with SSc. Macitentan is a highly potent, tissue-targeting dual endothelin receptor antagonist. Through complete blockade of endothelin action, macitentan is expected to protect tissue from the damaging effect of elevated endothelin. This therapy is not approved for the treatment of systemic sclerosis, but the use of an ERA is an attractive approach in combating the structural vascular damage observed in SSc leading to complications such as DUs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digital Ulcers
Keywords
digital ulcers, systemic sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
265 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Macitentan 3 mg
Arm Type
Active Comparator
Arm Description
Oral macitentan 3 mg, once daily
Arm Title
Macitentan 10 mg
Arm Type
Active Comparator
Arm Description
Oral macitentan 10 mg, once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral placebo, once daily
Intervention Type
Drug
Intervention Name(s)
Macitentan 3 mg
Other Intervention Name(s)
ACT-064992
Intervention Description
Macitentan 3-mg tablet once daily
Intervention Type
Drug
Intervention Name(s)
Macitentan 10 mg
Other Intervention Name(s)
ACT-064992
Intervention Description
Macitentan 10-mg tablet once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet matching macitentan tablet, once daily
Primary Outcome Measure Information:
Title
Incidence Rate of New Digital Ulcers (DUs) up to Week 16
Description
DUs were assessed at each visit starting with the screening visit. Only DUs from the proximal interphalangeal joint (PIP) distally (both on the dorsal and volar surface of the hand, including the digital tip) were recorded. The location of each DU was noted. At each subsequent visit the location of each new DU was noted. DUs that occurred and healed between visits and were reported by patients were not recorded as new DUs. The evaluation was performed by an experienced physician or a trained rater with expertise in the assessment of DUs in systemic sclerosis (SSc). For a given patient, DUs were assessed by the same rater at each visit, whenever possible. Any DU that developed over a previously healed ulcer was recorded as a new DU. Incidence rate is adjusted for 16 weeks of observation, hence is calculated as the number of new DUs/total number of observation days.
Time Frame
Baseline to Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants Without a New DU up to Week 16
Description
DUs were assessed at each visit starting with the screening visit. Only DUs from the proximal interphalangeal joint (PIP) distally (both on the dorsal and volar surface of the hand, including the digital tip) were recorded. The location of each DU was noted. At each subsequent visit the location of each new DU was noted. DUs that occurred and healed between visits and were reported by patients were not recorded as new DUs. The evaluation was performed by an experienced physician or a trained rater with expertise in the assessment of DUs in systemic sclerosis (SSc). For a given patient, DUs were assessed by the same rater at each visit, whenever possible. Any DU that developed over a previously healed ulcer was recorded as a new DU. Numbers of patients with no new DU at Week 16 are imputed using the last observation carried forward method.
Time Frame
Baseline to Week 16
Title
Percentage of Participants With at Least One DU Complication
Description
DU complications were defined as any one of the following: resulting from DU worsening: critical ischemic crisis necessitating hospitalization; gangrene, (auto)amputation; failure of conservative management; surgical and chemical sympathectomy, vascular reconstructions, or any unplanned surgery in the management of hand SSc manifestations; use of parenteral prostanoids; use of endothelin-receptor antagonists; class II, III, or IV narcotics or a > 50% increase in the existing dose compared with baseline; initiation of systemic antibiotics for the treatment of infection attributed to DUs.
Time Frame
Up to 95 weeks
Title
Change in Hand Functionality Health Assessment Questionnaire - Disability Index (HAQ-DI) Hand Component From Baseline to Week 16
Description
HAQ-DI assesses functional ability regarding fine movements of the upper extremities, locomotor activities in the lower extremities, and movements of the upper and lower limbs. Responses were extracted from the Scleroderma Health Assessment Questionnaire covering 8 domains of functional disability (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities). A mean score ranging from 0-3 was calculated for each domain, and a composite score by dividing the summed domain scores by the number of domains. The composite score was interpreted as 0 (no impairment in function) to 3 (maximal impairment of function). Hand functionality was assessed using a composite of 4 domains (dressing and grooming, grip, hygiene, and eating).
Time Frame
Baseline to Week 16
Title
Health Assessment Questionnaire - Disability Index (HAQ-DI) Overall Score From Baseline to Week 16
Description
HAQ-DI assesses functional ability regarding fine movements of the upper extremities, locomotor activities in the lower extremities, and movements of the upper and lower limbs. Responses were extracted from the Scleroderma Health Assessment Questionnaire covering 8 domains of functional disability (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities). A mean score ranging from 0-3 was calculated for each domain, and a composite score by dividing the summed domain scores by the number of domains. The composite score was interpreted as 0 (no impairment in function) to 3 (maximal impairment of function).
Time Frame
Baseline to Week 16
Title
Change in Hand Functionality - Hand Disability in Systemic Sclerosis - Digital Ulcers (HDISS-DU) Score From Baseline to Week 16
Description
Patients were asked to answer 24 questions on the use of the hand(s) affected by DUs over the past 7 days on a 6-point scale from 0 (yes without difficulty) to 5 (impossible). The HDISS-DU score is the arithmetic mean of the valid non-missing items. The scores are interpreted as 1 (better ability in completing activities) to 6 (worst ability in completing activities)
Time Frame
Baseline to Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria : Patients ≥ 18 years of age Women of childbearing potential must use two reliable methods of contraception Diagnosis of SSc according to the classification criteria of the American College of Rheumatology (ACR) At least one visible, active ischemic DU at baseline History of at least one additional recent active ischemic digital ulcer Exclusion Criteria : DUs due to condition other than SSc Symptomatic pulmonary arterial hypertension (PAH) Body mass index (BMI) < 18 kg/m^2 Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 x upper limit of normal (ULN) Hemoglobin < 75% of the lower limit of the normal range Systolic blood pressure < 95 mmHg or diastolic blood pressure < 50 mmHg Severe malabsorption; any severe organ failure (e.g., lung, kidney), or any life-threatening condition Females who are pregnant or breastfeeding or plan to do so during the course of this study Substance or alcohol abuse or dependence, or tobacco use at any level Treatment with phosphodiesterase-5 (PDE5) inhibitors Patients on statins, who have received treatment for less than 3 months prior to Screening or whose treatment has not been stable during this period Patients on vasodilators, who have received treatment for less than 2 weeks prior to Screening or whose treatment has not been stable during this period Treatment with prostanoids within 3 months Treatment with disease modifying agents if present for less than 3 months prior to Screening or whose treatment has not been stable for at least 1 month prior to Screening Treatment with oral corticosteroids (> 10 mg/day of prednisone or equivalent). Treatment with endothelin receptor antagonists (ERAs) within 3 months Systemic antibiotics to treat infected DU(s) within 4 weeks
Facility Information:
Facility Name
Stanford Univ. School of Medicine - Palo Alto VA Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of Connecticut Health Center - Division of Rheumatic Diseases
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-1310
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Millennium Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Florida Medical Clinic-PA
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Northwestern University - Feinberg School of Medicine Department of Rheumatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118-2394
Country
United States
Facility Name
Washington University School of Medicine
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
North Shore Long Island Jewish Health System - Div. of Rheumatology & Allergy-Clinical Immunology
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
The Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Ruppert Health Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
The University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Texas - Houston Medical School
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Arthritis Northwest PLLC
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Centro de Educacion Medica e Investigaciones Clinicas - CEMIC
City
Buenos Aires
ZIP/Postal Code
4102
Country
Argentina
Facility Name
Hospital Britanico de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
Country
Argentina
Facility Name
Sanatorio San Jose
City
Caba
ZIP/Postal Code
C1425DUH
Country
Argentina
Facility Name
Hospital Italiano de Cordoba
City
Cordoba
ZIP/Postal Code
X5004BAL
Country
Argentina
Facility Name
Hospital Privado Centro Medico de Cordoba S.A.
City
Cordoba
ZIP/Postal Code
x5016keh
Country
Argentina
Facility Name
Clinique Universitaires Saint Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Cliniques universitaires UCL Mont-Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
Guangdong General Hospital
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
Renji Hospital, Shanghai Jiaotong University
City
Shanghai
ZIP/Postal Code
200001
Country
China
Facility Name
First Affiliated Hospital of the Forth Military University
City
Xi'an
ZIP/Postal Code
710032
Country
China
Facility Name
Hospital Pablo Tobon Uribe
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
Centro Integral de Reumatologia y Inmunologia CIREI SAS
City
Bogota
Country
Colombia
Facility Name
Fundacion Instituto du Reumatologia Fernando Chalem
City
Bogota
Country
Colombia
Facility Name
Kerckhoff-Klinik GmbH
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Universitätsklinikum der Technischen Universität Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Hautklinik Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Department of Dermatology University Hospital Johannes Gutenberg
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Ludwig-Maximilian-Universität München Abteilung Dermatologie
City
Muchen
ZIP/Postal Code
80337
Country
Germany
Facility Name
Klinik und Poliklinik für Dermatologie und Allergologie am Biderstein des Klinikums rechts der Isar der Technischen Universität München
City
Muenchen
ZIP/Postal Code
80802
Country
Germany
Facility Name
General University Hospital LAIKO/A' Propaideftiki Pathology Clinic
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
EUROMEDICA - Kyanos Stavros
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
General University Hospital AHEPA
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
Cork University Hospital
City
Cork
ZIP/Postal Code
C1
Country
Ireland
Facility Name
Beaumont Hospital
City
Dublin
ZIP/Postal Code
2
Country
Ireland
Facility Name
St. Vincents University Hospital
City
Dublin
ZIP/Postal Code
4
Country
Ireland
Facility Name
Mid-Western Regional Hospital
City
Limerick
Country
Ireland
Facility Name
Sheba Medical Center
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Asaf Harofe Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Unidad de Investigacion en Enfermedades Cronico Degeneratives SC
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44620
Country
Mexico
Facility Name
Christus Muguerza del Parque Hospital
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Clinica Diagnostico y Tratamiento de las Enfermedades Reumaticas
City
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Hospital Civil de Guadalajara - Fray Antonio Alacade Hospital No. 278
City
Guadalajara
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Hospital Aranda de la Parra Leon
City
Leon
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Hospital Angeles Lindavista
City
Madero
ZIP/Postal Code
07760
Country
Mexico
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubrian
City
Mexico D.F.
ZIP/Postal Code
14000
Country
Mexico
Facility Name
VU University Medical Center
City
Amsterdam
ZIP/Postal Code
1081
Country
Netherlands
Facility Name
UMC St Radboud
City
GA Nijmegen
ZIP/Postal Code
6525
Country
Netherlands
Facility Name
Middlemore Hospital
City
Auckland
ZIP/Postal Code
1640
Country
New Zealand
Facility Name
Dunedin Hospital
City
Dunedin
ZIP/Postal Code
9054
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
North Shore Hospital, STAR (Shore Trials and Research) Unit
City
North Shore
ZIP/Postal Code
0620
Country
New Zealand
Facility Name
Wellington Hospital
City
Wellington South
ZIP/Postal Code
7902
Country
New Zealand
Facility Name
Prywatna Praktyka Lekarska Prof. UM dr hab. med. Paweł Hrycaj
City
Poznań
ZIP/Postal Code
61-397
Country
Poland
Facility Name
SPSK Nr 1 PUM Szczecin
City
Szczecin
ZIP/Postal Code
71-752
Country
Poland
Facility Name
Reumatika - Centrum Reumatologii NZOZ
City
Warszawa
ZIP/Postal Code
02-653
Country
Poland
Facility Name
Wojskowy Instytut Medyczny CSK MON
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
SPSK Nr 1 Wrocław
City
Wrocław
ZIP/Postal Code
50-368
Country
Poland
Facility Name
Instituto Português de Reumatologia
City
Lisboa
ZIP/Postal Code
1050-034
Country
Portugal
Facility Name
University of Puerto Rico
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
State Institution, "Institute of Rheumatology of RAMS"
City
Moscow
ZIP/Postal Code
115552
Country
Russian Federation
Facility Name
Municipal Treatment and Prevention Institution, "City Clinical Hospital #5"
City
Nizhniy Novgorod
ZIP/Postal Code
603005
Country
Russian Federation
Facility Name
State Educational Institution of High Professional Education "Voronezh State Medical Academy named after N.N.Burdenko of Roszdrav"
City
Voronezh
ZIP/Postal Code
394036
Country
Russian Federation
Facility Name
Groote Schuur Hospital, University of Cape Town
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Louis Pasteur Medical Centre
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Chris Hani Baragwanath Hospital
City
Soweto
ZIP/Postal Code
2013
Country
South Africa
Facility Name
HOSPITAL Universitario VALL D'HEBRON - Servicio Medicina Interna
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Çukurova Üniversitesi Tıp Fakültesi ROMATOLOJİ BİLİM DALI
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Dokuz Eylul Universitesi Tip Fakultesi Romatoloji Bilim Dali
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Municipal Healthcare Institution "Donetsk Regional Clinical Hospital of Occupational Diseases"
City
Donetsk
ZIP/Postal Code
83059
Country
Ukraine
Facility Name
National scientific centre "Institute of Cardiology named after M. Strazheska"
City
Kyiv
ZIP/Postal Code
03151
Country
Ukraine
Facility Name
Crimean Republican Institution 'Clinical territorial medical union 'University Clinic
City
Simferopol
ZIP/Postal Code
95017
Country
Ukraine
Facility Name
Vinnytsia Regional Clinical Hospital named after M. Pyrogov
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Scientific and Research Institute of Handicapped Rehabilitation of Vinnitsa National Medical University named after M. Pirogova
City
Vinnytsya
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Royal National Hospital
City
Bath
ZIP/Postal Code
BA1 1RL
Country
United Kingdom
Facility Name
Addenbrooke's Hospital - University of Cambridge School of Clinical Medicine
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
University Hospital Aintree - Rheumatology Department
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Royal Free & University College Medical School
City
London
ZIP/Postal Code
NW3 2PF
Country
United Kingdom
Facility Name
University of Manchester School of Translational Medicine Musculoskeletal Research Group
City
Manchester
ZIP/Postal Code
M13 9PT
Country
United Kingdom
Facility Name
Ninewells Hospital & Medical School
City
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Torbay Hospital
City
Torbay
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27163986
Citation
Khanna D, Denton CP, Merkel PA, Krieg T, Le Brun FO, Marr A, Papadakis K, Pope J, Matucci-Cerinic M, Furst DE; DUAL-1 Investigators; DUAL-2 Investigators. Effect of Macitentan on the Development of New Ischemic Digital Ulcers in Patients With Systemic Sclerosis: DUAL-1 and DUAL-2 Randomized Clinical Trials. JAMA. 2016 May 10;315(18):1975-88. doi: 10.1001/jama.2016.5258.
Results Reference
result

Learn more about this trial

Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients

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