Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2025-12-25 @ 11:59 AM
Study NCT ID:
NCT03975361
Status:
UNKNOWN
Last Update Posted:
2021-05-25
First Post:
2019-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Autoreactivity Threshold Analysis in Lupus and Immune Thrombocytopenia (Checkpoints ITP and SLE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2022-04-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-21', 'studyFirstSubmitDate': '2019-05-24', 'studyFirstSubmitQcDate': '2019-06-04', 'lastUpdatePostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of polyreactive and autoreactive cells in immature and naïve B cells subsets in the peripheral blood', 'timeFrame': '1 year', 'description': 'Number of polyreactive and autoreactive cells in immature (central tolerance) and naïve B cells (peripheral tolerance) subsets in the peripheral blood along the RITUX-PLUS and the BLISS BELIEVE studies after treatment (reconstitution time).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rituximab'], 'conditions': ['Immune Thrombocytopenia (ITP)', 'Systemic Lupus Erythematosus (SLE)']}, 'descriptionModule': {'briefSummary': "The aim of this proposal is to test if anti-BAFF antibody can restore a normal threshold of tolerance in patients in two auto-immune diseases along the RITUX-PLUS study in immune thrombocytopenia, and along the Believe study in SLE. This work would help to conclude whether or not the 'double hit' therapy may help to reset the immune system toward a more tolerogenic profile.\n\nThe aim is to compare the polyreactivity and autoreactivity, of immature (central tolerance) and naïve B cells (peripheral tolerance) in the peripheral blood along the RITUX-PLUS STUDY and the BLISS BELIEVE study after treatment (B-cell reconstitution time)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'There are no specific inclusion and exclusion criteria for this study.\n\nThe inclusion and exclusion criteria are those of patients enrolled in the RITUX-PLUS (NCT03154385) and BLISS BELIEVE studies (NCT03312907) including the following inclusion criteria:\n\n* individuals are affiliated to social security\n* individuals not be placed under judicial protection, guardianship or curatoship'}, 'identificationModule': {'nctId': 'NCT03975361', 'acronym': 'ITP&SLE', 'briefTitle': 'Autoreactivity Threshold Analysis in Lupus and Immune Thrombocytopenia (Checkpoints ITP and SLE)', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Tolerance Checkpoints Upon the B-cell Depletion Plus BAFF Blockade Strategy in Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE) (Checkpoints ITP and SLE)', 'orgStudyIdInfo': {'id': 'APHP180341'}, 'secondaryIdInfos': [{'id': '2019-A00103-54', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Bliss-Believe', 'description': 'Patients included in the BLISS-BELIEVE study (NCT03312907).', 'interventionNames': ['Other: Bliss-Believe']}], 'interventions': [{'name': 'Bliss-Believe', 'type': 'OTHER', 'description': 'The samples from the blood samples carried out within the framework of Bliss Believe will be collected for a biological collection. Only one sample of patients included in BLISS BELIEVE STUDY will be obtained during a standard of care visit. It will be 21ml of blood.', 'armGroupLabels': ['Bliss-Believe']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Matthieu MAHEVAS, PHD', 'role': 'CONTACT'}], 'facility': 'Henri Mondor Hospital', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Zahir AMOURA', 'role': 'CONTACT'}], 'facility': 'Pitie Salpetriere Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Mahevas Matthieu', 'role': 'CONTACT', 'email': 'matthieu.mahevas@aphp.fr', 'phone': '01 49 81 20 76'}], 'overallOfficials': [{'name': 'Mahevas Matthieu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}