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The "DeSScipher" Project - to Decipher the Best Treatment for Systemic Sclerosis - Observational Trial 2: Improvement of Hand Dysfunction by Arthritis in Systemic Sclerosis
Sponsor study identifier
observational
160
14 countries
33
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Systemic sclerosis (SSc) is an orphan, multiorgan disease affecting the connective tissue of the skin and several internal organs. Beside skin involvement, digital ulcers, tendinitis, calcinosis and flexion contractures, the presence of hand arthritis is a major contributor to impairment of hand function in systemic sclerosis. Several immunomodulatory drugs used in other rheumatic diseases (including methotrexate, leflunomide, azathioprine, mycophenolate mofetil and low-dose corticosteroids) can potentially improve arthritis and consequently hand function in systemic sclerosis. For the assessment of arthritis, the CDAI (clinical disease activity index) is validated in rheumatoid arthritis, and may be useful for SSc-related arthritis, too. 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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
April 9, 2013
Actual (reported)April 17, 2013
Actual (reported)November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Improvement of HAQ-DI (CHAQ-DI in jSSc) by at least -0.21 in one year
Improvement from baseline in Health Assessment Questionnaire - Disability Index (Child Health Assessment Questionnaire - Disability Index in juvenile systemic sclerosis) by at least -0,21(moderate improvement) in one year
12 months
Improvement of the CHFS in one year
12 months
Improvement of the CDAI in one year
12 months
Improvement of the SDAI in one year
12 months
Improvement of the DAS28(We) in one year
12 months
Improvement of the DAS28(CRP) in one year
12 months
Validation of the CDAI in systemic sclerosis
12 months
Validation of the SDAI in systemic sclerosis
12 months
Validation of the DAS28(ESR) in systemic sclerosis
12 months
methotrexate with or without low-dose corticosteroids
other DMARDs (leflunomide, azathioprine, mycophenolate mofetil) with or without low-dose corticosteroids
low-dose corticosteroids without DMARDs
No DMARD or corticosteroid treatment
cyclophosphamide or cyclosporine-A with or without other DMARDs or low-dose corticosteroids
Biologic therapy with or without other DMARDs or low-dose corticosteroids
Combination of two or more DMARDs with or without low-dose corticosteroids
The study population is adult and juvenile systemic sclerosis patients from the EUSTAR cohort (MEDSonline database) and the jSScWG cohort.
University of Ghent, Department of Rheumatology
Ghent, 9000, Belgium
Dubrava University Hospital
Zagreb, Croatia
Assiut and Sohage University Hospital Rheumatology Department Assiut University Hospital
Asyut, Egypt
Ulf Müller-Ladner, Prof.
Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
Laszlo Czirjak, Prof
PECSI TUDOMANYEGYETEM - UNIVERSITY OF PECS
First Submitted
April 9, 2013
First Posted
April 17, 2013
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2017
Contact the study team to confirm eligibility.
Department of Internal Medicine Hôpital Claude Huriez
Lille, 59035, France
Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016
Paris, 75014, France
Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
Bad Nauheim, 61231, Germany
Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie
Berlin, 10117, Germany
Universitätshautklinik Köln
Cologne, 50397, Germany
Universitätsklinikum Erlangen
Erlangen, 91054, Germany
Endokrinologikum Frankfurt
Frankfurt, 60596, Germany
Centre for Pediatric Rheumatology, Klinikum Eilbek
Hamburg, 22081, Germany
Medizinische Universitätsklinik Abt. II
Tübingen, 72076, Germany
Krankenhaus St. Josef
Wuppertal, 42105, Germany
Pecsi Tudomanyegyetem - University of Pecs
Pécs, H-7622, Hungary
Istituto di Clinica Medica Generale, Ematologia ed Immunologia Clinica, Università Politecnica delle Marche, Polo Didattico, University of Ancona
Ancona, 60020, Italy
University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine
Florence, 50139, Italy
Department of Rheumatology, University of Cagliari-Policlinico Universitario
Monserrato, 554, Italy
Policlinico, Via Pansini
Napoli-Italia, 5-80131, Italy
University of Padova
Padova, 35128, Italy
Divisione di Reumatologia, Università di Roma La Sapienza, Dipartimento di Clinica e Terapia medica applicata, Policlinico Umberto I
Roma, 00161, Italy
Department of Internal Medicine and Rheumatology Clinic, Ion Cantacuzino Clinical Hospital
Bucharest, 020475, Romania
Reumatologie, University of Medicine & Pharmacy,"Iuliu Hatieganu" Cluj
Cluj-Napoca, 40 0006, Romania
GR.T.Popa Center for Biomedical Research, European Center for Translational Research, "GR.T.Popa" University of Medicine and Pharmacy, Rehabilitation Hospital
Iași, 700661, Romania
Clinic of Nephrology, Internal and Occupational Diseases
Moscow, 119992, Russia
Institute of Rheumatology, Russian Academy of Medical Science
Moscow, 119992, Russia
Institute of Rheumatology Belgrade
Belgrade, 11000, Serbia
Hospital Universitario Madrid Norte Sanchinarro
Madrid, Spain
Felix-Platter Spital
Basel, CH 4012 Basel, Switzerland
University of Zurich, Department of Rheumatology
Zurich, 8006, 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, LS9 7TF, United Kingdom
Royal Free Hospital, University College London
London, NW3 2QG, United Kingdom
University of Manchester, Rheumatic Diseases Centre, Clinical Sciences
Manchester,Salford, United Kingdom
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 22, 2015
Record last verified: 2015-12
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