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

Systemic Sclerosis Clinical Trial

Official title:

Prevention and Treatment of Interstitial Lung Disease in Systemic Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01858259
• Other study ID #: HEALTH-F5-2012-305495-OT3
• Status: Recruiting
• Phase: N/A
• First received: May 14, 2013
• Last updated: August 12, 2014
• Start date: May 2013
• Est. completion date: June 2016

Study information

• Verified date: August 2014
• Source: Charite University, Berlin, Germany
• Contact: Gabriela Riemekasten, Prof.
• Email: Gabriela.Riemekasten[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionItaly: Ethics CommitteeHungary: Institutional Ethics CommitteeFrance: Institutional Ethical CommitteeSwitzerland: EthikkommissionUnited Kingdom: Research Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Interstitial Lung Diseases
• Lung Diseases
• Lung Diseases, Interstitial
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Locations

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

Sponsors (13)

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

Countries where clinical trial is conducted

France,  Germany,  Hungary,  Italy,  Switzerland,  United Kingdom, 

Outcome

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

External Links

•   Homepage of the DeSScipher project