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

Sponsor
Gabriela Riemekasten (Other)
Overall Status
Unknown status
CT.gov ID
NCT01858259
Collaborator
European Union (Other), University of Giessen (Other), University of Zurich (Other), University of Paris 5 - Rene Descartes (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)
1,372
Enrollment
11
Locations
37
Duration (Months)
124.7
Patients Per Site
3.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1372 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prevention and Treatment of Interstitial Lung Disease in Systemic Sclerosis
    Study Start Date :
    May 1, 2013
    Anticipated Primary Completion Date :
    Jun 1, 2016
    Anticipated Study Completion Date :
    Jun 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients with 10% decline in FVC [1 year]

      The proportion of patients with ILD progression as defined by a 10% decline in FVC within 1 year of therapy

    Secondary Outcome Measures

    1. The time to a 15% decline in DLCO or a drop <55% of predicted lung function [1 year]

    2. The mortality due to lung fibrosis [1 year]

    3. The need for oxygen support [1 year]

    Other Outcome Measures

    1. Identification of confounders [1 year]

      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.

    2. Evaluation of the incidence of drug-related adverse events [1 year]

    3. Evaluation of the incidence of withdrawal from treatment due to drug-related adverse events [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016 Paris France 75014
    2 Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology Bad Nauheim Germany 61231
    3 Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie Berlin Germany 10117
    4 Centre for Pediatric Rheumatology, Klinikum Eilbek Hamburg Germany 22081
    5 Pecsi Tudomanyegyetem - University of Pecs Pecs Hungary H-7622
    6 University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine Firenze Italy 50139
    7 Policlinico, Via Pansini Napoli-Italia Italy 5-80131
    8 Felix-Platter Spital, University of Basel Basel Switzerland CH 4012 Basel
    9 University of Zurich, Department of Rheumatology Zurich Switzerland 8006
    10 The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital Leeds United Kingdom LS9 7TF
    11 Royal Free Hospital, University College London London United Kingdom NW3 2QG

    Sponsors and Collaborators

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

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gabriela Riemekasten, Prof. Dr. med. Gabriela Riemekasten, Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT01858259
    Other Study ID Numbers:
    • HEALTH-F5-2012-305495-OT3
    First Posted:
    May 21, 2013
    Last Update Posted:
    Aug 13, 2014
    Last Verified:
    Aug 1, 2014
    Additional relevant MeSH terms:
    Lung Diseases
    Lung Diseases, Interstitial
    Scleroderma, Systemic
    Scleroderma, Diffuse
    Sclerosis

    Study Results

    No Results Posted as of Aug 13, 2014