Treatment and Prevention of Progression of Interstitial Lung Disease in Systemic Sclerosis

NCT01858259 | Unknown DMC

• 1 other identifier: HEALTH-F5-2012-305495-OT3
• Study Type: observational
• Target: 1,372
• Locations: 6 countries
• Sites: 11

Brief Summary

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

Conditions

Systemic Sclerosis; Interstitial Lung Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Other Outcomes (3)

• 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

Study Arms (5)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• Patients with previous exposure to silica or asbestos

Sponsors & Collaborators

• Gabriela Riemekasten: lead
• European Union: collaborator
• University of Giessen: collaborator
• University of Zurich: collaborator
• University of Paris 5 - Rene Descartes: collaborator
• University of Florence: collaborator
• University of Campania Luigi Vanvitelli: collaborator
• University of Basel: collaborator
• University College, London: collaborator
• Charite University, Berlin, Germany: collaborator
• University of Pecs: collaborator
• University of Leeds: collaborator
• Schoen Klinik Hamburg Eilbek: collaborator

Study Sites (11)

Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016

Paris, 75014, France

RECRUITING

Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology

Bad Nauheim, 61231, Germany

RECRUITING

Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie

Berlin, 10117, Germany

RECRUITING

Centre for Pediatric Rheumatology, Klinikum Eilbek

Hamburg, 22081, Germany

RECRUITING

Pecsi Tudomanyegyetem - University of Pecs

Pécs, H-7622, Hungary

RECRUITING

University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine

Florence, 50139, Italy

RECRUITING

Policlinico, Via Pansini

Napoli-Italia, 5-80131, Italy

RECRUITING

Felix-Platter Spital, University of Basel

Basel, CH 4012 Basel, Switzerland

RECRUITING

University of Zurich, Department of Rheumatology

Zurich, 8006, Switzerland

RECRUITING

The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital

Leeds, LS9 7TF, United Kingdom

RECRUITING

Royal Free Hospital, University College London

London, NW3 2QG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Scleroderma, Systemic; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Ulf Müller-Ladner, Prof.

  Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology

  STUDY CHAIR

Central Study Contacts

Gabriela Riemekasten, Prof.

CONTACT

Gabriela.Riemekasten@charite.de

Christopher Denton, Prof.

CONTACT

c.denton@ucl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med. Gabriela Riemekasten

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: May 21, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 13, 2014

Record last verified: 2014-08

Locations

FR (1); HU (1); CH (2); GB (2); IT (2); DE (3)