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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 all internal organs. Interstitial lung disease is a frequent morbidity and mortality-driving manifestation in systemic sclerosis.
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:
Patients are routinely evaluated every 3 months over a 12-months period by medical history, physical examination, pulmonary function tests, VAS lung score and SF-36, SHAQ. Also, their medication and possible medication changes will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cyclophosphamide | Patients receiving cyclophosphamide | ||
| azathioprine | Patients receiving azathioprine | ||
| mycophenolate mofetil | Patients receiving mycophenolate mofetil | ||
| methotrexate | Patients receiving methotrexate | ||
| no therapy | Patients receiving no immunosuppressive therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with 10% decline in FVC | The proportion of patients with ILD progression as defined by a 10% decline in FVC within 1 year of therapy | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The time to a 15% decline in DLCO or a drop <55% of predicted lung function | 1 year | |
| The mortality due to lung fibrosis | 1 year | |
| The need for oxygen support |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of confounders | Parameters with impact on ILD progression independent of therapies, such as SSc subgroups, presence of antibodies, presence of vasculopathy, time to therapy initiation, degree of lung fibrosis defined by FVC values, age at disease onset and at treatment initiation, gender, co-morbidities and other confounders. | 1 year |
Inclusion Criteria:
Exclusion Criterion:
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The study population are adult and juvenile SSc patients from the EUSTAR cohort (MEDSonline database) and the jSScWG cohort
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriela Riemekasten, Prof. | Contact | Gabriela.Riemekasten@charite.de | ||
| Christopher Denton, Prof. | Contact | c.denton@ucl.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Gabriela Riemekasten, Prof. | Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie | Principal Investigator |
| Christopher Denton, Prof. | Royal Free Hospital, University College London London |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016 | Recruiting | Paris | 75014 | France |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D008171 | Lung Diseases |
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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 Pecs | OTHER |
| University of Leeds | OTHER |
| Schoen Klinik Hamburg Eilbek | OTHER |
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| 1 year |
| Evaluation of the incidence of drug-related adverse events |
| 1 year |
| Evaluation of the incidence of withdrawal from treatment due to drug-related adverse events | 1 year |
| Principal Investigator |
| Ulf Müller-Ladner, Prof. | Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology | Study Chair |
| Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology | Recruiting | Bad Nauheim | 61231 | Germany |
|
| Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie | Recruiting | Berlin | 10117 | Germany |
|
| Centre for Pediatric Rheumatology, Klinikum Eilbek | Recruiting | Hamburg | 22081 | Germany |
|
| Pecsi Tudomanyegyetem - University of Pecs | Recruiting | Pécs | H-7622 | Hungary |
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| University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine | Recruiting | Florence | 50139 | Italy |
|
| Policlinico, Via Pansini | Recruiting | Napoli-Italia | 5-80131 | Italy |
|
| Felix-Platter Spital, University of Basel | Recruiting | Basel | CH 4012 Basel | Switzerland |
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| University of Zurich, Department of Rheumatology | Recruiting | Zurich | 8006 | Switzerland |
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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 |
|
| D012140 | Respiratory Tract Diseases |