search
Back to results

Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients (DUAL-1)

Primary Purpose

Systemic Sclerosis, Ulcers

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
macitentan 3mg
macitentan 10mg
placebo
Sponsored by
Actelion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Sclerosis focused on measuring systemic sclerosis, digital ulcers

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 digital ulcers (DU) at baseline
  • History of at least one additional recent active ischemic DU

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 the normal range (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 type-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 ERAs within 3 months.
  • Systemic antibiotics to treat infected DU(s) within 4 weeks.

Sites / Locations

  • University of Arizona Arthritis Center
  • UCLA Medical School - Rheumatology Division Rehabilitation Center
  • Arthritis & Rheumatic Disease Specialties
  • Sarasota Arthritis Research Center
  • Ochsner Medical Center
  • The Johns Hopkins University School of Medicine
  • University of Michigan - Scleroderma Program
  • Michigan State University
  • University of Medicine & Dentistry of New Jersey, UMDNJ Scleroderma Program
  • The Center for Rheumatology
  • Shanahan Rheumatology and Immunotherapy, PLLC
  • The Cleveland Clinic Foundation
  • Altoona Center for Clinical Research
  • University of Pittsburgh Department of Rheumatology
  • Medical University of South Carolina
  • Royal Adelaide Hospital
  • Wesley Hospital, Thoracic Department
  • Royal Prince Alfred Hospital
  • St Vincent's Hospital
  • Menzies Research Institute
  • Gomel Regional Clinical Hospital
  • Healthcare Institution "Minsk City Hospital #1"
  • Healthcare Institution "Minsk Clinical Hospital #9"
  • Multiprofile Hospital for Active Treatment "Sveti Pantaleymon"
  • MHAT "Kaspela" EOOD Plovdiv - Rheumatology Ward
  • MHAT "Sv. Ivan Rilski" EAD Sofia - Clinic of Rheumatology
  • Rheumatology Research Associates
  • St. Paul's Hospital
  • St. Joseph's Health Care
  • Mount Sinai Hospital
  • CHUS Hopital Fleurimont
  • Prosalud
  • Private Office Marta Aliste
  • Hospital San Juan de Dios
  • Centro de Estudios Clinicos V
  • Medicity S.A.S.
  • Servimed E.U.
  • Klinicki Bolnicki Centar Osijek
  • University Hospital Centre Rijeka
  • Klinički bolnički centar Split
  • Klinicka Bolnica "Svety Duh"
  • Klinička bolnica Dubrava
  • University Hospital Centre Zagreb
  • Lekarna FN Brno
  • Faculty Hospital Hradec Králové
  • Revmatologický ústav Praha
  • Bispebjerg Hospital København
  • Odense Universitetshospital
  • Helsingin yliopistollinen keskussairaala (HYKS), Meilahden kolmiosairaala, Reumatologian klinikka
  • Universitätsmedizin Berlin Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie
  • Klinik für Dermatologie und Allergologie der Ruhr-Universität Bochum
  • Medizinische Universitätsklinik Freiburg, Abt. Rheumatologie und klinische Forschung
  • Asklepios Westklinikum Hamburg Abteilung für Gefäßmedizin, Angiologie und Diabetologie
  • Rheumatologie, klinische Immunologie, Nephrologie Asklepios Rheumazentrum Hamburg Asklepios Klinik Altona
  • Akademie für Gefäßkrankheiten eV.
  • Klinik und Poliklinik für Dermatologie und Venerologie der Universität zu Köln
  • Universitäts-Hautklinik Tübingen
  • Budai Irgalmasrendi Kórház
  • Debreceni Egyetem Orvos- és Egészségtudományi Centrum
  • Pécsi Tudományegyetem Klinikai Központ, Reumatológiai és Immunológiai Klinika
  • Advance Rheumatology Clinic
  • Krishna Institute of Medical Sciences
  • Christian Medical College
  • Azienda Ospedaliera Careggi
  • Azienda Ospedaliera Policlinico di Modena
  • Complesso Integrato Columbus
  • Uniwersyteckie Centrum Kliniczne
  • NZOZ Reumed
  • Centralny Szpital Kliniczny MSWiA
  • Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
  • State Healthcare Institution "Sverdlovsk Regional Clinical Hospital #1"
  • State Healthcare Institution "Penza Regional Clinical Hospital named after N.N. Burdenko"
  • Vladimir Regional State Institution of Healthcare, "Regional Clinical Hospital"
  • Dinpropetrovsk Regional Clinical Hospital named after I. Mechnykova
  • Municipal Institution of Kyiv Regional Council, Kyiv Regional Clinical Hospital
  • Lviv Regional Clinical Hospital
  • Internal disease chair of Ukrainian medical dentist academy based on therapy department of Poltava Poltava City Clinical Hospital #1

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

macitentan 3mg

macitentan 10mg

placebo

Arm Description

macitentan 3mg tablet once daily

macitentan 10mg tablet once daily

matching 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
January 2, 2015
Sponsor
Actelion
search

1. Study Identification

Unique Protocol Identification Number
NCT01474109
Brief Title
Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients
Acronym
DUAL-1
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
January 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (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-1 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 will continue on their original randomized treatment into Period 2, until the last randomized patient has completed Period 1. Patients will be 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. 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
Systemic Sclerosis, Ulcers
Keywords
systemic sclerosis, digital ulcers

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
macitentan 3mg
Arm Type
Active Comparator
Arm Description
macitentan 3mg tablet once daily
Arm Title
macitentan 10mg
Arm Type
Active Comparator
Arm Description
macitentan 10mg tablet once daily
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
matching placebo once daily
Intervention Type
Drug
Intervention Name(s)
macitentan 3mg
Other Intervention Name(s)
ACT-064992
Intervention Description
macitentan 3mg tablet once daily
Intervention Type
Drug
Intervention Name(s)
macitentan 10mg
Other Intervention Name(s)
ACT-064992
Intervention Description
macitentan 10mg tablet once daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
matching placebo 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 approximately 90 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 digital ulcers (DU) at baseline History of at least one additional recent active ischemic DU 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 the normal range (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 type-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 ERAs within 3 months. Systemic antibiotics to treat infected DU(s) within 4 weeks.
Facility Information:
Facility Name
University of Arizona Arthritis Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
UCLA Medical School - Rheumatology Division Rehabilitation Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Arthritis & Rheumatic Disease Specialties
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Sarasota Arthritis Research Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
The Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224-6801
Country
United States
Facility Name
University of Michigan - Scleroderma Program
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Michigan State University
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
University of Medicine & Dentistry of New Jersey, UMDNJ Scleroderma Program
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903-0010
Country
United States
Facility Name
The Center for Rheumatology
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Shanahan Rheumatology and Immunotherapy, PLLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27617-7884
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
University of Pittsburgh Department of Rheumatology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-8905
Country
United States
Facility Name
Royal Adelaide Hospital
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
Wesley Hospital, Thoracic Department
City
Auchenflower
ZIP/Postal Code
4066
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Facility Name
St Vincent's Hospital
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Facility Name
Menzies Research Institute
City
Hobart
ZIP/Postal Code
7000
Country
Australia
Facility Name
Gomel Regional Clinical Hospital
City
Gomel
ZIP/Postal Code
246029
Country
Belarus
Facility Name
Healthcare Institution "Minsk City Hospital #1"
City
Minsk
ZIP/Postal Code
220013
Country
Belarus
Facility Name
Healthcare Institution "Minsk Clinical Hospital #9"
City
Minsk
ZIP/Postal Code
220116
Country
Belarus
Facility Name
Multiprofile Hospital for Active Treatment "Sveti Pantaleymon"
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
MHAT "Kaspela" EOOD Plovdiv - Rheumatology Ward
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
MHAT "Sv. Ivan Rilski" EAD Sofia - Clinic of Rheumatology
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
Rheumatology Research Associates
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5M 0H4
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
St. Joseph's Health Care
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
CHUS Hopital Fleurimont
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Prosalud
City
Santiago
ZIP/Postal Code
7510047
Country
Chile
Facility Name
Private Office Marta Aliste
City
Santiago
ZIP/Postal Code
7510186
Country
Chile
Facility Name
Hospital San Juan de Dios
City
Santiago
ZIP/Postal Code
8500000
Country
Chile
Facility Name
Centro de Estudios Clinicos V
City
Vina del Mar
ZIP/Postal Code
2570017
Country
Chile
Facility Name
Medicity S.A.S.
City
Bucaramanga
Country
Colombia
Facility Name
Servimed E.U.
City
Bucaramanga
Country
Colombia
Facility Name
Klinicki Bolnicki Centar Osijek
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
University Hospital Centre Rijeka
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Facility Name
Klinički bolnički centar Split
City
Split
ZIP/Postal Code
21000
Country
Croatia
Facility Name
Klinicka Bolnica "Svety Duh"
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinička bolnica Dubrava
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
University Hospital Centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Lekarna FN Brno
City
Brno
ZIP/Postal Code
62500
Country
Czech Republic
Facility Name
Faculty Hospital Hradec Králové
City
Hradec Králové
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Revmatologický ústav Praha
City
Praha
ZIP/Postal Code
12000
Country
Czech Republic
Facility Name
Bispebjerg Hospital København
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Odense Universitetshospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Helsingin yliopistollinen keskussairaala (HYKS), Meilahden kolmiosairaala, Reumatologian klinikka
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Universitätsmedizin Berlin Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Klinik für Dermatologie und Allergologie der Ruhr-Universität Bochum
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Medizinische Universitätsklinik Freiburg, Abt. Rheumatologie und klinische Forschung
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Asklepios Westklinikum Hamburg Abteilung für Gefäßmedizin, Angiologie und Diabetologie
City
Hamburg
ZIP/Postal Code
22559
Country
Germany
Facility Name
Rheumatologie, klinische Immunologie, Nephrologie Asklepios Rheumazentrum Hamburg Asklepios Klinik Altona
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
Akademie für Gefäßkrankheiten eV.
City
Karlsbad
ZIP/Postal Code
76307
Country
Germany
Facility Name
Klinik und Poliklinik für Dermatologie und Venerologie der Universität zu Köln
City
Koln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitäts-Hautklinik Tübingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Budai Irgalmasrendi Kórház
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Debreceni Egyetem Orvos- és Egészségtudományi Centrum
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Pécsi Tudományegyetem Klinikai Központ, Reumatológiai és Immunológiai Klinika
City
Pécs
ZIP/Postal Code
7632
Country
Hungary
Facility Name
Advance Rheumatology Clinic
City
Hyderabad
ZIP/Postal Code
500082
Country
India
Facility Name
Krishna Institute of Medical Sciences
City
Secunderabad
ZIP/Postal Code
500 003
Country
India
Facility Name
Christian Medical College
City
Vellore
ZIP/Postal Code
632004
Country
India
Facility Name
Azienda Ospedaliera Careggi
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Azienda Ospedaliera Policlinico di Modena
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Complesso Integrato Columbus
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdańsk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
NZOZ Reumed
City
Lublin
ZIP/Postal Code
20-607
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSWiA
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
City
Wrocław
ZIP/Postal Code
50-566
Country
Poland
Facility Name
State Healthcare Institution "Sverdlovsk Regional Clinical Hospital #1"
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
State Healthcare Institution "Penza Regional Clinical Hospital named after N.N. Burdenko"
City
Penza
ZIP/Postal Code
440026
Country
Russian Federation
Facility Name
Vladimir Regional State Institution of Healthcare, "Regional Clinical Hospital"
City
Vladimir
ZIP/Postal Code
600023
Country
Russian Federation
Facility Name
Dinpropetrovsk Regional Clinical Hospital named after I. Mechnykova
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Municipal Institution of Kyiv Regional Council, Kyiv Regional Clinical Hospital
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Lviv Regional Clinical Hospital
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Internal disease chair of Ukrainian medical dentist academy based on therapy department of Poltava Poltava City Clinical Hospital #1
City
Poltava
ZIP/Postal Code
36039
Country
Ukraine

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
derived

Learn more about this trial

Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients

We'll reach out to this number within 24 hrs