Treatment and Prevention of Progression of Interstitial Lung Disease in Systemic Sclerosis
NCT ID: NCT01858259
Last Updated: 2014-08-13
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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UNKNOWN
1372 participants
OBSERVATIONAL
2013-05-31
2016-06-30
Brief Summary
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This observational trial (OT) is part of the collaborative project "DeSScipher", one out of five OTs to decipher the optimal management of systemic sclerosis. Aim of this observational try is to identify:
* The state of clinical practice in Europe for prevention and treatment of interstitial lung disease and its impact on lung function and disease progression
* The potential predictors and confounders for response to therapy
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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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cyclophosphamide
Patients receiving cyclophosphamide
No interventions assigned to this group
azathioprine
Patients receiving azathioprine
No interventions assigned to this group
mycophenolate mofetil
Patients receiving mycophenolate mofetil
No interventions assigned to this group
methotrexate
Patients receiving methotrexate
No interventions assigned to this group
no therapy
Patients receiving no immunosuppressive therapy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* SSc patients with proven ILD (by X-ray or CT scan)
* Treatment with standard dosages according to current practice with (i) cyclophosphamide, (ii) azathioprine, (iii) mycophenolate mofetil, (iv) methotrexate, or (v) no therapy
Exclusion Criterion:
* Patients with previous exposure to silica or asbestos
ALL
No
Sponsors
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European Union
OTHER
University of Giessen
OTHER
University of Zurich
OTHER
University of Paris 5 - Rene Descartes
OTHER
University of Florence
OTHER
University of Campania Luigi Vanvitelli
OTHER
University of Basel
OTHER
University College, London
OTHER
Charite University, Berlin, Germany
OTHER
University of Pecs
OTHER
University of Leeds
OTHER
Schoen Klinik Hamburg Eilbek
OTHER
Gabriela Riemekasten
OTHER
Responsible Party
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Gabriela Riemekasten
Prof. Dr. med. Gabriela Riemekasten
Principal Investigators
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Gabriela Riemekasten, Prof.
Role: PRINCIPAL_INVESTIGATOR
Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie
Christopher Denton, Prof.
Role: PRINCIPAL_INVESTIGATOR
Royal Free Hospital, University College London London
Ulf Müller-Ladner, Prof.
Role: STUDY_CHAIR
Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
Locations
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Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016
Paris, , France
Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
Bad Nauheim, , Germany
Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie
Berlin, , Germany
Centre for Pediatric Rheumatology, Klinikum Eilbek
Hamburg, , Germany
Pecsi Tudomanyegyetem - University of Pecs
Pécs, , Hungary
University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine
Florence, , Italy
Policlinico, Via Pansini
Napoli-Italia, , Italy
Felix-Platter Spital, University of Basel
Basel, , Switzerland
University of Zurich, Department of Rheumatology
Zurich, , Switzerland
The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital
Leeds, , United Kingdom
Royal Free Hospital, University College London
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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HEALTH-F5-2012-305495-OT3
Identifier Type: -
Identifier Source: org_study_id
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