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| Name | Class |
|---|---|
| European Union | OTHER |
| University of Giessen | OTHER |
| University of Zurich | OTHER |
| University of Paris 5 - Rene Descartes |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| methotrexate | methotrexate with or without low-dose corticosteroids | ||
| other DMARDs | other DMARDs (leflunomide, azathioprine, mycophenolate mofetil) with or without low-dose corticosteroids | ||
| low-dose corticosteroids | low-dose corticosteroids without DMARDs | ||
| No DMARD or corticosteroids | No DMARD or corticosteroid treatment | ||
| CPH/CSA - Exploratory cohort | cyclophosphamide or cyclosporine-A with or without other DMARDs or low-dose corticosteroids | ||
| Biologics - Exploratory cohort | Biologic therapy with or without other DMARDs or low-dose corticosteroids | ||
| Combinations - Exploratory cohort | Combination of two or more DMARDs with or without low-dose corticosteroids |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of the CHFS in one year | Improvement of the Cochin Hand Function Scale in one year | 12 months |
| Improvement of the CDAI in one year | Improvement of the Clinical Disease Activity Index in one year |
| Measure | Description | Time Frame |
|---|---|---|
| Validation of the CDAI in systemic sclerosis | Exploratory endpoint: Validation of the Clinical Disease Activity Index in systemic sclerosis | 12 months |
| Validation of the SDAI in systemic sclerosis | Exploratory endpoint: Validation of the Simplified Disease Activity Index in systemic sclerosis |
Inclusion Criteria:
Exclusion Criteria:
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The study population is adult and juvenile systemic sclerosis patients from the EUSTAR cohort (MEDSonline database) and the jSScWG cohort.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laszlo Czirjak, Prof. | Contact | laszlo.czirjak@aok.pte.hu |
| Name | Affiliation | Role |
|---|---|---|
| Ulf Müller-Ladner, Prof. | Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology | Study Chair |
| Laszlo Czirjak, Prof | PECSI TUDOMANYEGYETEM - UNIVERSITY OF PECS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ghent, Department of Rheumatology | Recruiting | Ghent | 9000 | Belgium |
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| 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 |
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| 12 months |
| Improvement of the SDAI in one year | Improvement of the Simplified Disease Activity Index in one year | 12 months |
| Improvement of the DAS28(We) in one year | Improvement of the Disease Activity Score 28 (using 4 variables, including erythrocyte sedimentation rate) in one year | 12 months |
| Improvement of the DAS28(CRP) in one year | Improvement of the Disease Activity Score 28 (using 4 variables, including C-reactive protein) in one year | 12 months |
| 12 months |
| Validation of the DAS28(ESR) in systemic sclerosis | Exploratory endpoint: Validation of the Disease Activity Score 28 (using 4 variables, including erythrocyte sedimentation rate) in systemic sclerosis | 12 months |
| Validation of the DAS28(CRP) in systemic sclerosis | Exploratory endpoint: Validation of the Disease Activity Score 28 (using 4 variables, including C-reactive protein) in systemic sclerosis | 12 months |
| Evaluation of the incidence and potential predictors of deterioration of hand dysfunction and progression of arthritis in systemic sclerosis | Evaluation of the incidence and potential predictors of deterioration of hand dysfunction and progression of arthritis in systemic sclerosis | 24 months |
| Incidence of drug-related adverse events | Evaluation of the incidence of drug-related adverse events | 24 months |
| Incidence of withdrawal from treatment due to drug-related adverse events | Evaluation of the incidence of withdrawal from treatment due to drug-related adverse events | 24 months |
| Dubrava University Hospital | Recruiting | Zagreb | Croatia |
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| Assiut and Sohage University Hospital Rheumatology Department Assiut University Hospital | Recruiting | Asyut | Egypt |
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| Department of Internal Medicine Hôpital Claude Huriez | Recruiting | Lille | 59035 | France |
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| Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016 | Recruiting | Paris | 75014 | France |
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| Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology | Recruiting | Bad Nauheim | 61231 | Germany |
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| Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie | Recruiting | Berlin | 10117 | Germany |
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| Universitätshautklinik Köln | Recruiting | Cologne | 50397 | Germany |
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| Universitätsklinikum Erlangen | Recruiting | Erlangen | 91054 | Germany |
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| Endokrinologikum Frankfurt | Recruiting | Frankfurt | 60596 | Germany |
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| Centre for Pediatric Rheumatology, Klinikum Eilbek | Recruiting | Hamburg | 22081 | Germany |
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| Medizinische Universitätsklinik Abt. II | Recruiting | Tübingen | 72076 | Germany |
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| Krankenhaus St. Josef | Recruiting | Wuppertal | 42105 | Germany |
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| Pecsi Tudomanyegyetem - University of Pecs | Recruiting | Pécs | H-7622 | Hungary |
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| Istituto di Clinica Medica Generale, Ematologia ed Immunologia Clinica, Università Politecnica delle Marche, Polo Didattico, University of Ancona | Recruiting | Ancona | 60020 | Italy |
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| University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine | Recruiting | Florence | 50139 | Italy |
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| Department of Rheumatology, University of Cagliari-Policlinico Universitario | Recruiting | Monserrato | 554 | Italy |
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| Policlinico, Via Pansini | Recruiting | Napoli-Italia | 5-80131 | Italy |
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| University of Padova | Recruiting | Padova | 35128 | Italy |
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| Divisione di Reumatologia, Università di Roma La Sapienza, Dipartimento di Clinica e Terapia medica applicata, Policlinico Umberto I | Recruiting | Roma | 00161 | Italy |
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| Department of Internal Medicine and Rheumatology Clinic, Ion Cantacuzino Clinical Hospital | Recruiting | Bucharest | 020475 | Romania |
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| Reumatologie, University of Medicine & Pharmacy,"Iuliu Hatieganu" Cluj | Recruiting | Cluj-Napoca | 40 0006 | Romania |
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| GR.T.Popa Center for Biomedical Research, European Center for Translational Research, "GR.T.Popa" University of Medicine and Pharmacy, Rehabilitation Hospital | Recruiting | Iași | 700661 | Romania |
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| Clinic of Nephrology, Internal and Occupational Diseases | Recruiting | Moscow | 119992 | Russia |
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| Institute of Rheumatology, Russian Academy of Medical Science | Recruiting | Moscow | 119992 | Russia |
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| Institute of Rheumatology Belgrade | Recruiting | Belgrade | 11000 | Serbia |
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| Hospital Universitario Madrid Norte Sanchinarro | Recruiting | Madrid | Spain |
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| Felix-Platter Spital | Recruiting | Basel | CH 4012 Basel | Switzerland |
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| University of Zurich, Department of Rheumatology | Recruiting | Zurich | 8006 | Switzerland |
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| University of Marmara, Department of Rheumatology | Recruiting | Istanbul | Turkey (Türkiye) |
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| The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital | Recruiting | Leeds | LS9 7TF | United Kingdom |
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| Royal Free Hospital, University College London | Recruiting | London | NW3 2QG | United Kingdom |
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| University of Manchester, Rheumatic Diseases Centre, Clinical Sciences | Recruiting | Manchester,Salford | United Kingdom |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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