Status:
UNKNOWN
Treatment and Prevention of Progression of Interstitial Lung Disease in Systemic Sclerosis
Lead Sponsor:
Gabriela Riemekasten
Collaborating Sponsors:
European Union
University of Giessen
Conditions:
Systemic Sclerosis
Interstitial Lung Diseases
Eligibility:
All Genders
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 m...
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 p...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2016
Estimated Enrollment :
1372 Patients enrolled
Trial Details
Trial ID
NCT01858259
Start Date
May 1 2013
End Date
June 1 2016
Last Update
August 13 2014
Active Locations (11)
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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