Prevention and Treatment of Interstitial Lung Disease in Systemic Sclerosis

This study is currently recruiting participants.
Verified May 2013 by Charite University, Berlin, Germany
Sponsor:
Collaborators:
European Union
University of Giessen
University of Zurich
University of Paris 5 - Rene Descartes
University of Florence
Second University of Naples
University of Basel
University College, London
Charite University, Berlin, Germany
University of Pecs
University of Leeds
Hamburg Centre for Pediatric Rheumatology, Klinikum Eilbek, Germany
Information provided by (Responsible Party):
Gabriela Riemekasten, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01858259
First received: May 14, 2013
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

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

Condition
Systemic Sclerosis
Interstitial Lung Diseases

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Prevention and Treatment of Interstitial Lung Disease in Systemic Sclerosis

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Proportion of patients with 10% decline in FVC [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The proportion of patients with ILD progression as defined by a 10% decline in FVC within 1 year of therapy


Secondary Outcome Measures:
  • The time to a 15% decline in DLCO or a drop <55% of predicted lung function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The mortality due to lung fibrosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The need for oxygen support [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1372
Study Start Date: May 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients receiving cyclophosphamide
Patients receiving azathioprine
Patients receiving mycophenolate mofetil
Patients receiving methotrexate
Patients receiving no therapy

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study population are adult and juvenile SSc patients from the EUSTAR cohort (MEDSonline database) and the jSScWG cohort

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01858259

Contacts
Contact: Gabriela Riemekasten, Prof. Gabriela.Riemekasten@charite.de
Contact: Christopher Denton, Prof. c.denton@ucl.ac.uk

Locations
France
Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016 Recruiting
Paris, France, 75014
Principal Investigator: Yannick Allanore, Prof.         
Germany
Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology Recruiting
Bad Nauheim, Germany, 61231
Principal Investigator: Ulf Müller-Ladner, Prof.         
Sub-Investigator: Ingo H. Tarner, Dr.         
Sub-Investigator: Marc Frerix, Dr.         
Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie Recruiting
Berlin, Germany, 10117
Principal Investigator: Gabriela Riemekasten, Prof.         
Centre for Pediatric Rheumatology, Klinikum Eilbek Recruiting
Hamburg, Germany, 22081
Principal Investigator: Ivan Foeldvari, Dr.         
Hungary
Pecsi Tudomanyegyetem - University of Pecs Recruiting
Pecs, Hungary, H-7622
Principal Investigator: Laszlo Czirjak, Prof.         
Italy
University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine Recruiting
Firenze, Italy, 50139
Principal Investigator: Marco Matucci-Cerinic, Prof.         
Policlinico, Via Pansini Recruiting
Napoli-Italia, Italy, 5-80131
Principal Investigator: Gabriele Valentini, Prof         
Switzerland
Felix-Platter Spital, University of Basel Recruiting
Basel, Switzerland, CH 4012 Basel
Principal Investigator: Ulrich Walker, Prof.         
University of Zurich, Department of Rheumatology Recruiting
Zurich, Switzerland, 8006
Principal Investigator: Oliver Distler, Prof.         
United Kingdom
The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital Recruiting
Leeds, United Kingdom, LS9 7TF
Principal Investigator: Francesco Del Galdo, Dr.         
Royal Free Hospital, University College London Recruiting
London, United Kingdom, NW3 2QG
Principal Investigator: Christopher Denton, Prof.         
Sponsors and Collaborators
Gabriela Riemekasten
European Union
University of Giessen
University of Zurich
University of Paris 5 - Rene Descartes
University of Florence
Second University of Naples
University of Basel
University College, London
Charite University, Berlin, Germany
University of Pecs
University of Leeds
Hamburg Centre for Pediatric Rheumatology, Klinikum Eilbek, Germany
Investigators
Principal Investigator: 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
Study Chair: Ulf Müller-Ladner, Prof. Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
  More Information

Additional Information:
No publications provided

Responsible Party: Gabriela Riemekasten, Prof. Dr. med. Gabriela Riemekasten, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01858259     History of Changes
Other Study ID Numbers: HEALTH-F5-2012-305495-OT3
Study First Received: May 14, 2013
Last Updated: May 16, 2013
Health Authority: Germany: Ethics Commission
Italy: Ethics Committee
Hungary: Institutional Ethics Committee
France: Institutional Ethical Committee
Switzerland: Ethikkommission
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Lung Diseases
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Lung Diseases, Interstitial
Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2014