Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT02903212
Status:
UNKNOWN
Last Update Posted:
2022-04-06
First Post:
2016-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis
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': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-05', 'studyFirstSubmitDate': '2016-09-01', 'studyFirstSubmitQcDate': '2016-09-12', 'lastUpdatePostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tolerance of apoptotic cells injection', 'timeFrame': '12 weeks', 'description': 'Side effects are taken into account to assess tolerance.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Apoptotic cells'], 'conditions': ['Arthritis, Rheumatoid']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to determine the tolerance of apoptotic autologous cells injection in subjects with active rheumatoid arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a diagnosis of Rheumatoid arthritis\n* Therapy failure with at least one biological agent from anti-TNF-alpha (etanercept, infliximab, adalimumab, certolizumab and golimumab; 3 months at optimal dose), anti-IL6 (tocilizumab; 3 months); T-cell costimulatory pathway inhibitor (abatacept; 3 months); anti-CD20 (rituximab; 6 months at optimal dose); Anti IL-1 (anakinra; 3 months)\n* Disease Activity Score (DAS) DAS28 ≥ 3.2\n* Subject has provided written informed consent\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Inflammatory arthritis other than rheumatoid arthritis\n* History of invasive cancer\n* Immunodeficiency (HIV infection, Immunosuppressive therapy)\n* Active bacterial or viral infections, in particular HCV or HBV.\n* Surgery not older than 4 weeks.\n* Unstable comorbidities: uncontrolled diabetes, heart disease, advanced renal or hepatic impairment.\n* Contraindication to an apheresis'}, 'identificationModule': {'nctId': 'NCT02903212', 'acronym': 'APO-RA', 'briefTitle': 'Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'P/2013/196'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rheumatoid arthritis', 'description': 'Patients with rheumatoid arthritis. An injection of autologous apoptotic cells is performed on the D0.', 'interventionNames': ['Biological: Autologous apoptotic cells injection']}], 'interventions': [{'name': 'Autologous apoptotic cells injection', 'type': 'BIOLOGICAL', 'description': 'cells injection', 'armGroupLabels': ['Rheumatoid arthritis']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Charline Vauchy, PhD', 'role': 'CONTACT', 'email': 'cvauchy@chu-besancon.fr', 'phone': '+33381218875'}, {'name': 'Elise Robert', 'role': 'CONTACT', 'email': 'e1robert@chu-besancon.fr', 'phone': '0381219086'}], 'overallOfficials': [{'name': 'Eric Toussirot, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rhumatology - CHU Besançon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}