Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-05 @ 9:41 AM
Study NCT ID:
NCT01770834
Status:
COMPLETED
Last Update Posted:
2018-03-02
First Post:
2013-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-28', 'studyFirstSubmitDate': '2013-01-16', 'studyFirstSubmitQcDate': '2013-01-16', 'lastUpdatePostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety: Incidence of adverse events', 'timeFrame': 'approximately 3 years'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients achieving a clinically meaningful improvement in disease activity: DAS28 reduction of at least 1.2 units, low disease activity (DAS28 </= 3.2) or remission (DAS28 <2.6)', 'timeFrame': 'approximately 3 years'}, {'measure': 'Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment', 'timeFrame': 'approximately 3 years'}, {'measure': 'Treatment regimens: Concomitant medications', 'timeFrame': 'approximately 3 years'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This prospective, observational study will evaluate the efficacy, safety and tolerability of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more conventional disease-modifying anti-rheumatic drugs. Data will be collected from patients initiated on RoActemra/Actemra treatment according to the local label at baseline, Weeks 4, 12 and 24, and at 3 and 6 months after the last dose of study drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with moderate to severe rheumatoid arthritis and an inadequate response or intolerant to previous therapy with conventional DMARDs', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/= 21 years of age\n* Moderate to severe active rheumatoid arthritis (DAS28 \\>/= 3.2)\n* Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs)\n* Initiated on RoActemra/Actemra treatment in accordance with the prescribing information\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Contra-indication to RoActemra/Actemra treatment according to the local labelling\n* Previous treatment with tocilizumab\n* Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra\n* Women of childbearing potential not using effective methods of contraception as defined by protocol'}, 'identificationModule': {'nctId': 'NCT01770834', 'briefTitle': 'A Prospective, Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Prospective, Non-interventional Multi-center Observational Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis in Routine Practice', 'orgStudyIdInfo': {'id': 'ML25533'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13041', 'city': 'Safat', 'country': 'Kuwait', 'geoPoint': {'lat': 29.37136, 'lon': 47.97298}}, {'zip': '11-236', 'city': 'Beirut', 'country': 'Lebanon', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'zip': '470 Hazmieh', 'city': 'Beirut', 'country': 'Lebanon', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'zip': '961', 'city': 'Beirut', 'country': 'Lebanon', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'zip': '99999', 'city': 'Beirut', 'country': 'Lebanon', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'city': 'Beirut', 'country': 'Lebanon', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'zip': '1401', 'city': 'Byblos', 'country': 'Lebanon', 'geoPoint': {'lat': 34.12111, 'lon': 35.64806}}, {'zip': '652', 'city': 'Saida', 'country': 'Lebanon', 'geoPoint': {'lat': 33.55751, 'lon': 35.37148}}, {'zip': '371 Tripoli', 'city': 'Tripoli', 'country': 'Lebanon', 'geoPoint': {'lat': 34.43352, 'lon': 35.84415}}, {'zip': '3050', 'city': 'Doha', 'country': 'Qatar', 'geoPoint': {'lat': 25.28545, 'lon': 51.53096}}, {'zip': 'P.O. Box 31500', 'city': 'Dubai', 'country': 'United Arab Emirates', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}, {'zip': 'P.O. Box 8179', 'city': 'Dubai', 'country': 'United Arab Emirates', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}