Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-01-01 @ 2:14 PM
Study NCT ID:
NCT01834157
Status:
UNKNOWN
Last Update Posted:
2015-12-22
First Post:
2013-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improvement of Hand Dysfunction by Arthritis in Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-21', 'studyFirstSubmitDate': '2013-04-09', 'studyFirstSubmitQcDate': '2013-04-13', 'lastUpdatePostDateStruct': {'date': '2015-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Validation of the CDAI in systemic sclerosis', 'timeFrame': '12 months', 'description': 'Exploratory endpoint: Validation of the Clinical Disease Activity Index in systemic sclerosis'}, {'measure': 'Validation of the SDAI in systemic sclerosis', 'timeFrame': '12 months', 'description': 'Exploratory endpoint: Validation of the Simplified Disease Activity Index in systemic sclerosis'}, {'measure': 'Validation of the DAS28(ESR) in systemic sclerosis', 'timeFrame': '12 months', 'description': 'Exploratory endpoint: Validation of the Disease Activity Score 28 (using 4 variables, including erythrocyte sedimentation rate) in systemic sclerosis'}, {'measure': 'Validation of the DAS28(CRP) in systemic sclerosis', 'timeFrame': '12 months', 'description': 'Exploratory endpoint: Validation of the Disease Activity Score 28 (using 4 variables, including C-reactive protein) in systemic sclerosis'}, {'measure': 'Evaluation of the incidence and potential predictors of deterioration of hand dysfunction and progression of arthritis in systemic sclerosis', 'timeFrame': '24 months', 'description': 'Evaluation of the incidence and potential predictors of deterioration of hand dysfunction and progression of arthritis in systemic sclerosis'}, {'measure': 'Incidence of drug-related adverse events', 'timeFrame': '24 months', 'description': 'Evaluation of the incidence of drug-related adverse events'}, {'measure': 'Incidence of withdrawal from treatment due to drug-related adverse events', 'timeFrame': '24 months', 'description': 'Evaluation of the incidence of withdrawal from treatment due to drug-related adverse events'}], 'primaryOutcomes': [{'measure': 'Improvement of HAQ-DI (CHAQ-DI in jSSc) by at least -0.21 in one year', 'timeFrame': '12 months', 'description': 'Improvement from baseline in Health Assessment Questionnaire - Disability Index (Child Health Assessment Questionnaire - Disability Index in juvenile systemic sclerosis) by at least -0,21(moderate improvement) in one year'}], 'secondaryOutcomes': [{'measure': 'Improvement of the CHFS in one year', 'timeFrame': '12 months', 'description': 'Improvement of the Cochin Hand Function Scale in one year'}, {'measure': 'Improvement of the CDAI in one year', 'timeFrame': '12 months', 'description': 'Improvement of the Clinical Disease Activity Index in one year'}, {'measure': 'Improvement of the SDAI in one year', 'timeFrame': '12 months', 'description': 'Improvement of the Simplified Disease Activity Index in one year'}, {'measure': 'Improvement of the DAS28(We) in one year', 'timeFrame': '12 months', 'description': 'Improvement of the Disease Activity Score 28 (using 4 variables, including erythrocyte sedimentation rate) in one year'}, {'measure': 'Improvement of the DAS28(CRP) in one year', 'timeFrame': '12 months', 'description': 'Improvement of the Disease Activity Score 28 (using 4 variables, including C-reactive protein) in one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Systemic Sclerosis', 'Arthritis']}, 'descriptionModule': {'briefSummary': 'Systemic sclerosis (SSc) is an orphan, multiorgan disease affecting the connective tissue of the skin and several internal organs. Beside skin involvement, digital ulcers, tendinitis, calcinosis and flexion contractures, the presence of hand arthritis is a major contributor to impairment of hand function in systemic sclerosis. Several immunomodulatory drugs used in other rheumatic diseases (including methotrexate, leflunomide, azathioprine, mycophenolate mofetil and low-dose corticosteroids) can potentially improve arthritis and consequently hand function in systemic sclerosis. For the assessment of arthritis, the CDAI (clinical disease activity index) is validated in rheumatoid arthritis, and may be useful for SSc-related arthritis, too.\n\nThis observational trial is part of the collaborative project "DeSScipher", one out of five observational trials to decipher the optimal management of systemic sclerosis. Aim of this observational trial is to:\n\n* investigate the efficacy and safety of different treatments on hand dysfunction in systemic sclerosis patients with hand arthritis and\n* to validate the CDAI for arthritis in systemic sclerosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is adult and juvenile systemic sclerosis patients from the EUSTAR cohort (MEDSonline database) and the jSScWG cohort.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Juvenile and adult Systemic sclerosis patients, with diagnosis according to the ACR/EULAR adult SSc criteria and PRES/ACR/EULAR juvenile SSc criteria respectively\n* Clinical signs of arthritis (defined as ≥2 tender and swollen joints)\n\nExclusion Criteria:\n\n* Presence of significant, long standing articular pain due to other cause than autoimmune disease\n* Presence of hand disability caused by other, than autoimmune disease'}, 'identificationModule': {'nctId': 'NCT01834157', 'briefTitle': 'Improvement of Hand Dysfunction by Arthritis in Systemic Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Pecs'}, 'officialTitle': 'The "DeSScipher" Project - to Decipher the Best Treatment for Systemic Sclerosis - Observational Trial 2: Improvement of Hand Dysfunction by Arthritis in Systemic Sclerosis', 'orgStudyIdInfo': {'id': 'HEALTH-F5-2012-305495-OT2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'methotrexate', 'description': 'methotrexate with or without low-dose corticosteroids'}, {'label': 'other DMARDs', 'description': 'other DMARDs (leflunomide, azathioprine, mycophenolate mofetil) with or without low-dose corticosteroids'}, {'label': 'low-dose corticosteroids', 'description': 'low-dose corticosteroids without DMARDs'}, {'label': 'No DMARD or corticosteroids', 'description': 'No DMARD or corticosteroid treatment'}, {'label': 'CPH/CSA - Exploratory cohort', 'description': 'cyclophosphamide or cyclosporine-A with or without other DMARDs or low-dose corticosteroids'}, {'label': 'Biologics - Exploratory cohort', 'description': 'Biologic therapy with or without other DMARDs or low-dose corticosteroids'}, {'label': 'Combinations - Exploratory cohort', 'description': 'Combination of two or more DMARDs with or without low-dose corticosteroids'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Vanessa Smith, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Ghent, Department of Rheumatology', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Zagreb', 'status': 'RECRUITING', 'country': 'Croatia', 'contacts': [{'name': 'Jadranka Morovic-Vergles', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dubrava University Hospital', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Manal Hassanien', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Assiut and Sohage University Hospital Rheumatology Department Assiut University Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}, {'zip': '59035', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eric Hachulla, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Internal Medicine Hôpital Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'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'}], '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': '50397', 'city': 'Cologne', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Nicolas Hunzelmann, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätshautklinik Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '91054', 'city': 'Erlangen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jörg Distler, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '60596', 'city': 'Frankfurt', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Brigitte Krummel-Lorenz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Endokrinologikum Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'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': '72076', 'city': 'Tübingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jörg Henes, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medizinische Universitätsklinik Abt. II', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '42105', 'city': 'Wuppertal', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Tim Schmeiser, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Krankenhaus St. Josef', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}, {'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': '60020', 'city': 'Ancona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Armando Gabrielli, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituto di Clinica Medica Generale, Ematologia ed Immunologia Clinica, Università Politecnica delle Marche, Polo Didattico, University of Ancona', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'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': '554', 'city': 'Monserrato', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandra Vacca', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Rheumatology, University of Cagliari-Policlinico Universitario', 'geoPoint': {'lat': 39.25642, 'lon': 9.1444}}, {'zip': '5-80131', 'city': 'Napoli-Italia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gabriele Valentini, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Policlinico, Via Pansini'}, {'zip': '35128', 'city': 'Padua', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Franco Cozzi, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '00161', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Guido Valesini, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Divisione di Reumatologia, Università di Roma La Sapienza, Dipartimento di Clinica e Terapia medica applicata, Policlinico Umberto I', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '020475', 'city': 'Bucharest', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Carina Mihai', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Internal Medicine and Rheumatology Clinic, Ion Cantacuzino Clinical Hospital', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '40 0006', 'city': 'Cluj-Napoca', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Simona Rednic', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Reumatologie, University of Medicine & Pharmacy,"Iuliu Hatieganu" Cluj', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'zip': '700661', 'city': 'Iași', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Cordina Ancuta', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'GR.T.Popa Center for Biomedical Research, European Center for Translational Research, "GR.T.Popa" University of Medicine and Pharmacy, Rehabilitation Hospital', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'zip': '119992', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Sergey Moiseev, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Antonina Sosnovskaya', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Clinic of Nephrology, Internal and Occupational Diseases', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119992', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Lidia Ananieva, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute of Rheumatology, Russian Academy of Medical Science', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '11000', 'city': 'Belgrade', 'status': 'RECRUITING', 'country': 'Serbia', 'contacts': [{'name': 'Nemanja Damjanov, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute of Rheumatology Belgrade', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Paloma García de la Peña Lefebvre de la Peña Lefebvre, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Madrid Norte Sanchinarro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'CH 4012 Basel', 'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Ulrich Walker, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Felix-Platter Spital', '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}}, {'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Sule Kurhan Yavuz, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Marmara, Department of Rheumatology', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'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}}, {'city': 'Manchester,Salford', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Ariane Herrick', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Manchester, Rheumatic Diseases Centre, Clinical Sciences'}], 'centralContacts': [{'name': 'Laszlo Czirjak, Prof.', 'role': 'CONTACT', 'email': 'laszlo.czirjak@aok.pte.hu'}], 'overallOfficials': [{'name': 'Ulf Müller-Ladner, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology'}, {'name': 'Laszlo Czirjak, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PECSI TUDOMANYEGYETEM - UNIVERSITY OF PECS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Laszlo Czirjak', '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 Leeds', 'class': 'OTHER'}, {'name': 'Schoen Klinik Hamburg Eilbek', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Laszlo Czirjak', 'investigatorFullName': 'Prof. Laszlo Czirjak', 'investigatorAffiliation': 'University of Pecs'}}}}