Systemic Sclerosis Clinical Trial
Official title:
Prevention and Treatment of Interstitial Lung Disease in Systemic Sclerosis
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:
- 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
Status | Recruiting |
Enrollment | 1372 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Diagnosis fo SSc according to the ACR/EULAR criteria for adult or the PRES/ACR/EULAR criteria for juvenile SSc patients - 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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016 | Paris | |
Germany | 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 | |
Hungary | Pecsi Tudomanyegyetem - University of Pecs | Pecs | |
Italy | University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine | Firenze | |
Italy | Policlinico, Via Pansini | Napoli-Italia | |
Switzerland | Felix-Platter Spital, University of Basel | Basel | |
Switzerland | University of Zurich, Department of Rheumatology | Zurich | |
United Kingdom | 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 |
Lead Sponsor | Collaborator |
---|---|
Gabriela Riemekasten | Charite University, Berlin, Germany, European Union, Schoen Klinik Hamburg Eilbek, Second University of Naples, University College, London, University of Basel, University of Florence, University of Giessen, University of Leeds, University of Paris 5 - Rene Descartes, University of Pecs, University of Zurich |
France, Germany, Hungary, Italy, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | No |
Other | Evaluation of the incidence of drug-related adverse events | 1 year | Yes | |
Other | Evaluation of the incidence of withdrawal from treatment due to drug-related adverse events | 1 year | Yes | |
Primary | 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 | No |
Secondary | The time to a 15% decline in DLCO or a drop <55% of predicted lung function | 1 year | No | |
Secondary | The mortality due to lung fibrosis | 1 year | No | |
Secondary | The need for oxygen support | 1 year | No |
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