Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-31 @ 2:15 PM
Study NCT ID:
NCT01543594
Status:
RECRUITING
Last Update Posted:
2020-09-29
First Post:
2012-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Italian Registry of Arthritis on Biologic Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-27', 'studyFirstSubmitDate': '2012-02-28', 'studyFirstSubmitQcDate': '2012-03-02', 'lastUpdatePostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rheumatoid arthritis', 'Seronegative polyarthritis', 'Biologic drugs', 'Safety efficacy biologics polyarthritis'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '32933920', 'type': 'DERIVED', 'citation': "Cacciapaglia F, Manfredi A, Erre G, Piga M, Sakellariou G, Viapiana O, Gremese E, Spinelli FR, Atzeni F, Bartoloni E. Correspondence on 'Characteristics associated with hospitalisation for COVID-19 in people with rheumatic disease: data from the COVID-19 global rheumatology alliance physician-reported registry' by Gianfrancesco M et al. The impact of cardiovascular comorbidity on COVID-19 infection in a large cohort of rheumatoid arthritis patients. Ann Rheum Dis. 2023 Jul;82(7):e159. doi: 10.1136/annrheumdis-2020-218813. Epub 2020 Sep 15. No abstract available."}, {'pmid': '24429167', 'type': 'DERIVED', 'citation': 'Iannone F, La Montagna G, Bagnato G, Gremese E, Giardina A, Lapadula G. Safety of etanercept and methotrexate in patients with rheumatoid arthritis and hepatitis C virus infection: a multicenter randomized clinical trial. J Rheumatol. 2014 Feb;41(2):286-92. doi: 10.3899/jrheum.130658. Epub 2014 Jan 15.'}]}, 'descriptionModule': {'briefSummary': 'The biologic drugs targeting TNFa, IL-6, IL-1, T cells, B cells have represented a fundamental discovery to treat rheumatic patients whose disease appears to be refractory to conventional therapy. These biologic drugs have been registered for human therapy from a few years, thereby the investigators miss long-term data for safety and efficacy. Aim of this study is to register all the clinical data of patients with rheumatoid arthritis and spondyloarthritis beginning a treatment with biologic drugs in order to assess the long-term safety and efficacy in the real life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients affected by active polyarthritis beginning conventional biologic drugs', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Rheumatoid arthritis, Ankylosing spondylitis, Psoriatic arthritis\n* Patients with active disease refractory to traditional disease modifying drugs (methotrexate, leflunomide, sulphasalazine, cyclosporine, hydrossiclorochine)\n* Patients eligible to begin conventional biologic therapy\n\nExclusion Criteria:\n\n* Any criteria excluding treatment with biologic drugs according to international guidelines'}, 'identificationModule': {'nctId': 'NCT01543594', 'acronym': 'GISEA', 'briefTitle': 'Italian Registry of Arthritis on Biologic Therapy', 'organization': {'class': 'NETWORK', 'fullName': 'Gruppo Italiano Studio Early Arthritis'}, 'officialTitle': 'Study of Efficacy and Safety of Biologic Drugs in the Therapy of Rheumatoid Arthritis and Spondyloarthritis', 'orgStudyIdInfo': {'id': 'DG-624'}, 'secondaryIdInfos': [{'id': '2012', 'type': 'OTHER', 'domain': 'ANMAR'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70124', 'city': 'Bari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Lapadula, MD', 'role': 'CONTACT', 'email': 'g.lapadula@reumabari.uniba.it', 'phone': '+390805478866'}, {'name': 'Giovanni Lapadula, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'GISEA', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}], 'centralContacts': [{'name': 'Giovanni Lapadula, MD', 'role': 'CONTACT', 'email': 'g.lapadula@reumbari.uniba.it', 'phone': '+390805478867'}], 'overallOfficials': [{'name': 'Florenzo Iannone, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Bari'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gruppo Italiano Studio Early Arthritis', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Rheumatology, University of Bari', 'investigatorFullName': 'Prof. Florenzo Iannone', 'investigatorAffiliation': 'Gruppo Italiano Studio Early Arthritis'}}}}