Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT01095393
Status:
COMPLETED
Last Update Posted:
2020-07-16
First Post:
2010-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
National Data Bank for Rheumatic Disease Registry Study of Safety in Patients With Rheumatoid Arthritis Treated With Cimzia® or Disease-modifying Antirheumatic Drugs (DMARDs)
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': 'ACTUAL', 'count': 12500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-15', 'studyFirstSubmitDate': '2010-03-26', 'studyFirstSubmitQcDate': '2010-03-29', 'lastUpdatePostDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with lymphoma', 'timeFrame': '6 years', 'description': 'Number of participants with lymphoma during the observational period (up to 6 years)'}], 'secondaryOutcomes': [{'measure': 'Number of participants with serious infections', 'timeFrame': '6 years', 'description': 'Number of participants with serious infections during the observational period (up to 6 years)'}, {'measure': 'Number of participants with non-lymphoma malignancies', 'timeFrame': '6 years', 'description': 'Number of participants with non-lymphoma malignancies during the observational period (up to 6 years)'}, {'measure': 'Number of participants with cardiovascular events', 'timeFrame': '6 years', 'description': 'Number of participants with cardiovascular events during the observational period (up to 6 years)'}, {'measure': 'Number of participants with thromboembolic events', 'timeFrame': '6 years', 'description': 'Number of participants with thromboembolic events during the observational period (up to 6 years)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Certolizumab Pegol', 'CZP', 'Cimzia®', 'NDB', 'registry'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'Observational registry to assess the longer-term risk of serious infections and malignancies reported with TNFα-blocker therapy, as well as the longer-term risk of cardiovascular and thromboembolic events in adult Rheumatoid Arthritis (RA) patients treated with Cimzia® as compared to non-biologic DMARD-treated controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Rheumatologist referral or patient direct enrollment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* RA and started treatment with certolizumab pegol (Cimzia®; CZP) or non-biologic DMARD within the last 6 months'}, 'identificationModule': {'nctId': 'NCT01095393', 'briefTitle': 'National Data Bank for Rheumatic Disease Registry Study of Safety in Patients With Rheumatoid Arthritis Treated With Cimzia® or Disease-modifying Antirheumatic Drugs (DMARDs)', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'National Data Bank for Rheumatic Disease (NDB) Registry Study of Safety in Rheumatoid Arthritis (RA) Patients Treated With Certolizumab Pegol (CZP; Cimzia®) and Non-biologic Disease-modifying Antirheumatic Drug (DMARD) Therapies', 'orgStudyIdInfo': {'id': 'RA0005'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Certolizumab pegol (CZP)', 'description': 'Patients with RA receiving treatment with certolizumab pegol (CZP; Cimzia®)'}, {'label': 'Non-biologic DMARD', 'description': 'Subjects with RA receiving treatment with non-biologic DMARD'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Frederick Wolfe, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Data Bank for Rheumatic Disease'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Pharma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Data Bank for Rheumatic Diseases (NDB)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}