Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-02-12 @ 4:22 PM
Study NCT ID:
NCT02721004
Status:
COMPLETED
Last Update Posted:
2016-07-04
First Post:
2016-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of RoActemra (Tocilizumab) in Participants With 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C502936', 'term': 'tocilizumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 592}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-01', 'studyFirstSubmitDate': '2016-03-02', 'studyFirstSubmitQcDate': '2016-03-22', 'lastUpdatePostDateStruct': {'date': '2016-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease Activity Score Based on 28-joints Count (DAS28)', 'timeFrame': 'Month 12'}, {'measure': 'Simplified Disease Activity Index (SDAI) Score', 'timeFrame': 'Month 12'}, {'measure': 'Clinical Disease Activity Index (CDAI) Score', 'timeFrame': 'Month 12'}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology (ACR) Response', 'timeFrame': 'Month 12'}, {'measure': 'Tender Joint Count (TJC)', 'timeFrame': 'Month 12'}, {'measure': 'Swollen Joint Count (SJC)', 'timeFrame': 'Month 12'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants with any Adverse Event (AE)', 'timeFrame': 'Up to 36 months'}]}, 'conditionsModule': {'keywords': ['Rheumatoid arthritis', 'RoActemra', 'Tocilizumab'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This is an open-label, non-interventional study to evaluate efficacy and safety in rheumatoid arthritis participants receiving tocilizumab as per the product label.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with rheumatoid arthritis will be enrolled in this trial.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Participants with rheumatoid arthritis receiving tocilizumab as per product label\n\nExclusion Criteria:\n\n\\- No specific exclusion criteria were specified for this non-interventional trial'}, 'identificationModule': {'nctId': 'NCT02721004', 'briefTitle': 'Efficacy and Safety Study of RoActemra (Tocilizumab) in Participants With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Documentation of the Efficacy and Safety of RoActemra in the Treatment of Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'ML22551'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rheumatoid arthritis participants', 'description': 'Rheumatoid arthritis participants receiving tocilizumab intravenous infusion every 4 weeks according to product label/per standard practice for a maximum of 12 months will be observed in this study.', 'interventionNames': ['Drug: Tocilizumab']}], 'interventions': [{'name': 'Tocilizumab', 'type': 'DRUG', 'otherNames': ['RoActemra'], 'description': 'Tocilizumab administered as an intravenous infusion every 4 weeks according to product label/per standard practice for a maximum of 12 months will be observed in this study.', 'armGroupLabels': ['Rheumatoid arthritis participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6700', 'city': 'Bludenz', 'country': 'Austria', 'geoPoint': {'lat': 47.15476, 'lon': 9.82255}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}