Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
630 participants
OBSERVATIONAL
2011-01-31
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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SSc DU-history subgroup
Systemic sclerosis patients with history of digital ulcers
No interventions assigned to this group
SSc with No-DU-history subgroup
Systemic sclerosis patients with no history of digital ulcers
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent prior to enrollment
* Male or female, ≥ 18 years of age
* Diagnosis of systemic sclerosis (SSc) according to the American College of Rheumatology and/or limited cutaneous SSc or diffuse cutaneous SSc according to LeRoy criteria
For patients with no history of digital ulcers (DU) and no DU at enrollment only:
\- Enrollment must be within 2 years of the first physician-documented non-Raynaud clinical feature
Exclusion Criteria
* Patients who underwent stem cell transplantation
* Participation in interventional clinical trials within 3 months prior to enrollment and/or during the study
* Inability to undergo Nailfold Videocapillaroscopy (NVC) assessment (e.g., inability to extend fingers sufficiently)
18 Years
ALL
No
Sponsors
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Actelion
INDUSTRY
Responsible Party
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Locations
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Medizinische Universität Graz
Graz, , Austria
Universitätsklinik für Innere Medizin Wien
Vienna, , Austria
Sozialmedizinisches Zentrum Süd-Kaiser-Franz-Josef-Spital
Vienna, , Austria
Hanusch Krankenhaus der Gebietskrankenkasse
Vienna, , Austria
Université Libre de Bruxelles Hopital Erasme
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Universitair Ziekenhuis Leuven
Leuven, , Belgium
Revmatologický ústav
Prague, , Czechia
Centre Hospitalier Universitaire Amiens
Amiens, , France
Centre Hospitalier Universitaire de Grenoble
La Tronche, , France
CHRU de Lille, hopital Claude Huriez, Service des maladies du sang
Lille, , France
CHU Dupuytren
Limoges, , France
Centre Hospitalier Universitaire de Nantes
Nantes, , France
Groupe Hospitalier Cochin Saint Vincent de Paul
Paris, , France
Hôpital Tenon
Paris, , France
Asklepios Klinikum Bad Abbach
Bad Abbach, , Germany
Kerckhoff-Klinik GmbH
Bad Nauheim, , Germany
Charité Universitätsmedizin Berlin
Berlin, , Germany
Sankt Josef-Hospital, Klinikum der Ruhr-Universität Bochum
Bochum-Gerthe, , Germany
Klinik und Poliklinik für Dermatologie und Venerologie der Universität zu Köln
Cologne, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Universitätsklinikum Halle (Saale)
Halle, , Germany
Asklepios Klinik Altona
Hamburg, , Germany
Universitätsklinikum Münster
Münster, , Germany
Laiko Hospital
Athens, , Greece
Rambam Medical Center
Haifa, , Israel
Bnai Zion Medical Center
Haifa, , Israel
Meir Medical Center
Kfar Saba, , Israel
Universita degli Studi di Brescia
Brescia, , Italy
Azienda Ospedaliera "Pugliese Ciaccio" di Catanzaro
Catanzaro, , Italy
Azienda Ospedale San Martino
Genova, , Italy
Ospedale Santa Ciara
Pisa, , Italy
Policlinico Umberto I
Roma, , Italy
Complesso Integrato Columbus
Roma, , Italy
Vrije Universiteit Medisch Centrum
Amsterdam, , Netherlands
Revmatismesykehuset
Lillehammer, , Norway
Hospital Geral de Santo Antonio
Porto, , Portugal
Hospital Sant Pau
Barcelona, , Spain
Hospital Vall D'Hebron
Barcelona, , Spain
Hospital de Mostoles
Madrid, , Spain
Hospital Doctor Peset
Valencia, , Spain
Centre Hospitalier Universitaire Vaudoise
Lausanne, , Switzerland
Kantonspital Sankt Gallen
Sankt Gallen, , Switzerland
UniversitätsSpital Zürich
Zurich, , Switzerland
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, , Turkey (Türkiye)
Bath Institute for Rheumatic Diseases
Bath, , United Kingdom
Chapel Allerton Hospital
Leeds, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Hope Hospital
Salford, , United Kingdom
Wrightington Hospital
Wigan, , United Kingdom
Countries
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Other Identifiers
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AC-052-521
Identifier Type: -
Identifier Source: org_study_id
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