Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT06790420
Status:
COMPLETED
Last Update Posted:
2025-05-31
First Post:
2025-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer] Post-marketing Database Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-30', 'studyFirstSubmitDate': '2025-01-09', 'studyFirstSubmitQcDate': '2025-01-21', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of infections which requires procedures, medication or hospitalization', 'timeFrame': 'From index date up to 180 days after last dose', 'description': 'until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up or the end of study period'}], 'secondaryOutcomes': [{'measure': "Incidence of 'pancytopenia, leukocytopenia, Neutropenia, agranulocytosis, thrombocytopenia'", 'timeFrame': 'From index date up to 180 days after last dose', 'description': 'until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up or the end of study period'}, {'measure': 'Incidence of Infusion reactions', 'timeFrame': 'From index date up to next day after last dose', 'description': 'until the first incidence of an event, date of switch to another Rituximab product, the end of risk window which is until next day after last dose, death, or the end of study period.'}, {'measure': 'Incidence of hepatic function disorder, jaundice', 'timeFrame': 'From index date up to 180 days after last dose', 'description': 'until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up or the end of study period'}, {'measure': 'Incidence of cardiac disorder', 'timeFrame': 'From index date up to 180 days after last dose', 'description': 'until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up or the end of study period'}, {'measure': 'Incidence of gastrointestinal perforation/obstruction', 'timeFrame': 'From index date up to 180 days after last dose', 'description': 'until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up or the end of study period'}, {'measure': 'Incidence of hypotension', 'timeFrame': 'From index date up to next day after last dose', 'description': 'until the first incidence of an event, date of switch to another Rituximab product, the end of risk window which is until next day after last dose, death, or the end of study period.'}, {'measure': 'Incidence of development of malignant tumor', 'timeFrame': 'From index date up to maximum of 5 years (the end of the study period)', 'description': 'follow until the first incident event, death, end of the study period, or loss to follow up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lymphoma', 'Rituximab', 'Infection'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': "To evaluate the incidence of the outcomes for the safety specifications in patients of Medical Data Vision database in Japan diagnosed with CD20 positive B-cell non- Hodgkin's lymphoma who were treated with Rituximab Pfizer to compare it with outcomes in patients who were treated with Rituxan from 01 January 2020 through 31 December 2024"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "The study population includes individuals who have a diagnosis of CD20 positive B-cell non- Hodgkin's lymphoma and treated with Rituximab Pfizer and Rituxan", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Have prescription of Rituximab Pfizer or Rituxan within the enrollment period (Index Date: first prescription date within the enrollment period).\n2. Have diagnosis of CD20 positive B-cell non- Hodgkin's lymphoma on the index month or within 6 months before index date\n3. Have at least 6 months of Look back period and at least one medical record prior to 7 months before the Index date.\n4. Have not prescription of Rituximab product before index date(Comparative Analysis Set only).\n\nExclusion Criteria:\n\n1\\. Have any diagnosis of other indications of rituximab products other than CD20 positive B-cell non- Hodgkin's lymphoma before index date ."}, 'identificationModule': {'nctId': 'NCT06790420', 'briefTitle': 'RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer] Post-marketing Database Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer] Post-marketing Database Study', 'orgStudyIdInfo': {'id': 'B3281009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exposed group', 'description': 'patients treated with Rituximab Pfizer', 'interventionNames': ['Drug: Rituximab Pfizer']}, {'label': 'Comparative group', 'description': 'patients treated with Rituxan', 'interventionNames': ['Drug: Rituxan']}], 'interventions': [{'name': 'Rituximab Pfizer', 'type': 'DRUG', 'description': 'For the acute therapy, Rituximab is administrated once a week up to 8 times and for maintenance therapy, it is administrated every 8 weeks up to 12 times', 'armGroupLabels': ['Exposed group']}, {'name': 'Rituxan', 'type': 'DRUG', 'description': 'For the acute therapy, Rituximab is administrated once a week up to 8 times and for maintenance therapy, it is administrated every 8 weeks up to 12 times', 'armGroupLabels': ['Comparative group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Pfizer', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}