NCT01858259|UnknownDMC
Treatment and Prevention of Progression of Interstitial Lung Disease in Systemic Sclerosis
Prevention and Treatment of Interstitial Lung Disease in Systemic Sclerosis
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Prevention and Treatment of Interstitial Lung Disease in Systemic Sclerosis
Sponsor study identifier
observational
1,372
6 countries
11
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2016
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 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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2016
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.
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
May 14, 2013
Actual (reported)May 21, 2013
Actual (reported)June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
1 year
Identification of confounders
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
Patients receiving cyclophosphamide
Patients receiving azathioprine
Patients receiving mycophenolate mofetil
Patients receiving methotrexate
Patients receiving no immunosuppressive therapy
The study population are adult and juvenile SSc patients from the EUSTAR cohort (MEDSonline database) and the jSScWG cohort
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
Gabriela Riemekasten, Prof.
Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie
Christopher Denton, Prof.
Royal Free Hospital, University College London London
Ulf Müller-Ladner, Prof.
Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
First Submitted
May 14, 2013
First Posted
May 21, 2013
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2016
Scleroderma Lung Study III - Combining Pirfenidone With Mycophenolate
Contact the study team to confirm eligibility.
Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie
Berlin, 10117, Germany
Centre for Pediatric Rheumatology, Klinikum Eilbek
Hamburg, 22081, Germany
Pecsi Tudomanyegyetem - University of Pecs
Pécs, H-7622, Hungary
University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine
Florence, 50139, Italy
Policlinico, Via Pansini
Napoli-Italia, 5-80131, Italy
Felix-Platter Spital, University of Basel
Basel, CH 4012 Basel, Switzerland
University of Zurich, Department of Rheumatology
Zurich, 8006, Switzerland
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
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 13, 2014
Record last verified: 2014-08
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