Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-01-26 @ 2:21 AM
Study NCT ID:
NCT02963402
Status:
COMPLETED
Last Update Posted:
2018-11-14
First Post:
2016-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunoregulatory Mechanisms of Treg Cells Induced by Tocilizumab
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C502936', 'term': 'tocilizumab'}, {'id': 'D000068879', 'term': 'Adalimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-12', 'studyFirstSubmitDate': '2016-11-10', 'studyFirstSubmitQcDate': '2016-11-10', 'lastUpdatePostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treg phenotype', 'timeFrame': 'Baseline to 6 months change'}, {'measure': 'ATP (adenosine triphosphate)', 'timeFrame': 'Baseline to 6 months change'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arthritis,Rheumatoid']}, 'descriptionModule': {'briefSummary': 'We can speculate that the best responders to tocilizumab should have multiple related elements (Treg CD39, adenosine, IL-35) successfully induced and expressed in order to play its beneficial role. The study of these elements and its pathways could help identify the best responders to tocilizumab treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'AR patients treated with tocilizumab in monotherapy or treated with adalimumab as control.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of all sexes, aged ≥ 18 years.\n* RA Patients (according to ACR / EULAR criteria 2010) of moderate to severe activity (DAS 28\\> 3.2 or SDAI\\> 11), and 6 months or more of evolution, starting treatment with ACTEMRA (tocilizumab) or with an anti-TNF, according to the product data.\n* Patients with body weight ≤ 150 kg.\n* Patients who have received written information about the study and gave their informed consent to participate in the study\n\nExclusion Criteria:\n\n* Patients with a history of autoimmune disease or inflammatory joint disease other than RA.\n* Patients treated with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is greater) before starting treatment with tocilizumab'}, 'identificationModule': {'nctId': 'NCT02963402', 'briefTitle': 'Immunoregulatory Mechanisms of Treg Cells Induced by Tocilizumab', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Analysis of Immunoregulatory Mechanisms of Treg Cells Induced by Tocilizumab', 'orgStudyIdInfo': {'id': 'IIBSP-TOC-2016-09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tocilizumab treated', 'interventionNames': ['Drug: Tocilizumab']}, {'label': 'Anti-TNF treated', 'interventionNames': ['Drug: Adalimumab']}], 'interventions': [{'name': 'Tocilizumab', 'type': 'DRUG', 'armGroupLabels': ['Tocilizumab treated']}, {'name': 'Adalimumab', 'type': 'DRUG', 'armGroupLabels': ['Anti-TNF treated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Insitut de Recerca Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}