Ignite Creation Date:
2025-12-24 @ 2:48 PM
Ignite Modification Date:
2025-12-26 @ 11:55 AM
Study NCT ID:
NCT01858259
Status:
UNKNOWN
Last Update Posted:
2014-08-13
First Post:
2013-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment and Prevention of Progression of Interstitial Lung Disease in Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1372}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-08-12', 'studyFirstSubmitDate': '2013-05-14', 'studyFirstSubmitQcDate': '2013-05-16', 'lastUpdatePostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Identification of confounders', 'timeFrame': '1 year', 'description': '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.'}, {'measure': 'Evaluation of the incidence of drug-related adverse events', 'timeFrame': '1 year'}, {'measure': 'Evaluation of the incidence of withdrawal from treatment due to drug-related adverse events', 'timeFrame': '1 year'}], 'primaryOutcomes': [{'measure': 'Proportion of patients with 10% decline in FVC', 'timeFrame': '1 year', 'description': 'The proportion of patients with ILD progression as defined by a 10% decline in FVC within 1 year of therapy'}], 'secondaryOutcomes': [{'measure': 'The time to a 15% decline in DLCO or a drop <55% of predicted lung function', 'timeFrame': '1 year'}, {'measure': 'The mortality due to lung fibrosis', 'timeFrame': '1 year'}, {'measure': 'The need for oxygen support', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Systemic Sclerosis', 'Interstitial Lung Diseases']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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:\n\n* The state of clinical practice in Europe for prevention and treatment of interstitial lung disease and its impact on lung function and disease progression\n* The potential predictors and confounders for response to therapy', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population are adult and juvenile SSc patients from the EUSTAR cohort (MEDSonline database) and the jSScWG cohort', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis fo SSc according to the ACR/EULAR criteria for adult or the PRES/ACR/EULAR criteria for juvenile SSc patients\n* SSc patients with proven ILD (by X-ray or CT scan)\n* Treatment with standard dosages according to current practice with (i) cyclophosphamide, (ii) azathioprine, (iii) mycophenolate mofetil, (iv) methotrexate, or (v) no therapy\n\nExclusion Criterion:\n\n* Patients with previous exposure to silica or asbestos'}, 'identificationModule': {'nctId': 'NCT01858259', 'briefTitle': 'Treatment and Prevention of Progression of Interstitial Lung Disease in Systemic Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Prevention and Treatment of Interstitial Lung Disease in Systemic Sclerosis', 'orgStudyIdInfo': {'id': 'HEALTH-F5-2012-305495-OT3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cyclophosphamide', 'description': 'Patients receiving cyclophosphamide'}, {'label': 'azathioprine', 'description': 'Patients receiving azathioprine'}, {'label': 'mycophenolate mofetil', 'description': 'Patients receiving mycophenolate mofetil'}, {'label': 'methotrexate', 'description': 'Patients receiving methotrexate'}, {'label': 'no therapy', 'description': 'Patients receiving no immunosuppressive therapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yannick Allanore, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '61231', 'city': 'Bad Nauheim', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ulf Müller-Ladner, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ingo H. Tarner, Dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marc Frerix, Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'zip': '10117', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Gabriela Riemekasten, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '22081', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ivan Foeldvari, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre for Pediatric Rheumatology, Klinikum Eilbek', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': 'H-7622', 'city': 'Pécs', 'status': 'RECRUITING', 'country': 'Hungary', 'contacts': [{'name': 'Laszlo Czirjak, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pecsi Tudomanyegyetem - University of Pecs', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '50139', 'city': 'Florence', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marco Matucci-Cerinic, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '5-80131', 'city': 'Napoli-Italia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gabriele Valentini, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Policlinico, Via Pansini'}, {'zip': 'CH 4012 Basel', 'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Ulrich Walker, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Felix-Platter Spital, University of Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '8006', 'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Oliver Distler, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Zurich, Department of Rheumatology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Francesco Del Galdo, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'NW3 2QG', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Christopher Denton, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Free Hospital, University College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Gabriela Riemekasten, Prof.', 'role': 'CONTACT', 'email': 'Gabriela.Riemekasten@charite.de'}, {'name': 'Christopher Denton, Prof.', 'role': 'CONTACT', 'email': 'c.denton@ucl.ac.uk'}], 'overallOfficials': [{'name': 'Gabriela Riemekasten, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie'}, {'name': 'Christopher Denton, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Free Hospital, University College London London'}, {'name': 'Ulf Müller-Ladner, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gabriela Riemekasten', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Union', 'class': 'OTHER'}, {'name': 'University of Giessen', 'class': 'OTHER'}, {'name': 'University of Zurich', 'class': 'OTHER'}, {'name': 'University of Paris 5 - Rene Descartes', 'class': 'OTHER'}, {'name': 'University of Florence', 'class': 'OTHER'}, {'name': 'University of Campania Luigi Vanvitelli', 'class': 'OTHER'}, {'name': 'University of Basel', 'class': 'OTHER'}, {'name': 'University College, London', 'class': 'OTHER'}, {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, {'name': 'University of Pecs', 'class': 'OTHER'}, {'name': 'University of Leeds', 'class': 'OTHER'}, {'name': 'Schoen Klinik Hamburg Eilbek', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Gabriela Riemekasten', 'investigatorFullName': 'Gabriela Riemekasten', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}