Improvement of Hand Dysfunction by Arthritis in Systemic Sclerosis
NCT ID: NCT01834157
Last Updated: 2015-12-22
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
160 participants
OBSERVATIONAL
2013-04-30
2017-11-30
Brief Summary
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This observational trial is part of the collaborative project "DeSScipher", one out of five observational trials to decipher the optimal management of systemic sclerosis. Aim of this observational trial is to:
* investigate the efficacy and safety of different treatments on hand dysfunction in systemic sclerosis patients with hand arthritis and
* to validate the CDAI for arthritis in systemic sclerosis.
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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methotrexate
methotrexate with or without low-dose corticosteroids
No interventions assigned to this group
other DMARDs
other DMARDs (leflunomide, azathioprine, mycophenolate mofetil) with or without low-dose corticosteroids
No interventions assigned to this group
low-dose corticosteroids
low-dose corticosteroids without DMARDs
No interventions assigned to this group
No DMARD or corticosteroids
No DMARD or corticosteroid treatment
No interventions assigned to this group
CPH/CSA - Exploratory cohort
cyclophosphamide or cyclosporine-A with or without other DMARDs or low-dose corticosteroids
No interventions assigned to this group
Biologics - Exploratory cohort
Biologic therapy with or without other DMARDs or low-dose corticosteroids
No interventions assigned to this group
Combinations - Exploratory cohort
Combination of two or more DMARDs with or without low-dose corticosteroids
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Clinical signs of arthritis (defined as ≥2 tender and swollen joints)
Exclusion Criteria
* Presence of hand disability caused by other, than autoimmune disease
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 Leeds
OTHER
Schoen Klinik Hamburg Eilbek
OTHER
Prof. Laszlo Czirjak
OTHER
Responsible Party
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Prof. Laszlo Czirjak
Prof. Laszlo Czirjak
Principal Investigators
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Ulf Müller-Ladner, Prof.
Role: STUDY_CHAIR
Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
Laszlo Czirjak, Prof
Role: PRINCIPAL_INVESTIGATOR
PECSI TUDOMANYEGYETEM - UNIVERSITY OF PECS
Locations
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University of Ghent, Department of Rheumatology
Ghent, , Belgium
Dubrava University Hospital
Zagreb, , Croatia
Assiut and Sohage University Hospital Rheumatology Department Assiut University Hospital
Asyut, , Egypt
Department of Internal Medicine Hôpital Claude Huriez
Lille, , France
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
Universitätshautklinik Köln
Cologne, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Endokrinologikum Frankfurt
Frankfurt, , Germany
Centre for Pediatric Rheumatology, Klinikum Eilbek
Hamburg, , Germany
Medizinische Universitätsklinik Abt. II
Tübingen, , Germany
Krankenhaus St. Josef
Wuppertal, , Germany
Pecsi Tudomanyegyetem - University of Pecs
Pécs, , Hungary
Istituto di Clinica Medica Generale, Ematologia ed Immunologia Clinica, Università Politecnica delle Marche, Polo Didattico, University of Ancona
Ancona, , Italy
University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine
Florence, , Italy
Department of Rheumatology, University of Cagliari-Policlinico Universitario
Monserrato, , Italy
Policlinico, Via Pansini
Napoli-Italia, , Italy
University of Padova
Padua, , Italy
Divisione di Reumatologia, Università di Roma La Sapienza, Dipartimento di Clinica e Terapia medica applicata, Policlinico Umberto I
Roma, , Italy
Department of Internal Medicine and Rheumatology Clinic, Ion Cantacuzino Clinical Hospital
Bucharest, , Romania
Reumatologie, University of Medicine & Pharmacy,"Iuliu Hatieganu" Cluj
Cluj-Napoca, , Romania
GR.T.Popa Center for Biomedical Research, European Center for Translational Research, "GR.T.Popa" University of Medicine and Pharmacy, Rehabilitation Hospital
Iași, , Romania
Clinic of Nephrology, Internal and Occupational Diseases
Moscow, , Russia
Institute of Rheumatology, Russian Academy of Medical Science
Moscow, , Russia
Institute of Rheumatology Belgrade
Belgrade, , Serbia
Hospital Universitario Madrid Norte Sanchinarro
Madrid, , Spain
Felix-Platter Spital
Basel, , Switzerland
University of Zurich, Department of Rheumatology
Zurich, , Switzerland
University of Marmara, Department of Rheumatology
Istanbul, , Turkey (Türkiye)
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
University of Manchester, Rheumatic Diseases Centre, Clinical Sciences
Manchester,Salford, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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HEALTH-F5-2012-305495-OT2
Identifier Type: -
Identifier Source: org_study_id