Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-30 @ 3:37 PM
Study NCT ID:
NCT01214733
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2010-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of RoActemra/Actemra (Tocilizumab) Plus DMARDs in Patients 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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-01', 'studyFirstSubmitDate': '2010-10-04', 'studyFirstSubmitQcDate': '2010-10-04', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety (incidence of adverse events)', 'timeFrame': '104 weeks'}, {'measure': 'Safety (laboratory assessments e.g. hematology)', 'timeFrame': '104 weeks'}], 'secondaryOutcomes': [{'measure': 'Efficacy: Change in Disease Activity Score (DAS28)', 'timeFrame': '104 weeks'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This open-label study will evaluate the long-term safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with disease modifying anti-rheumatic drugs (DMARDs) in patients with moderate to severe rheumatoid arthritis. Patients who successfully completed studies WA17823 and WA18696 in South Africa are eligible to participate in this study. Patients will be allowed DMARDs according to the treatment they received in the previous studies. Patients will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks. The anticipated time on study treatment is 104 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/=18 years of age\n* Moderate to severe rheumatoid arthritis of more than 6 months duration upon entering the study\n* Patients successfully completed studies WA17823 and WA18696 in South Africa\n* Body weight \\<150 kg\n\nExclusion Criteria:\n\n* Patients who have withdrawn from studies WA17823 and WA18696 are not eligible to participate in this study Treatment with any investigational agent since last administration of study drug in studies WA17823 and WA18696\n* Previous treatment with any cell depleting therapies\n* Treatment with intravenous gamma globulin, plasmapheresis or Prosorba(TM) column since the last administration of study drug in studies WA17823 and WA18696'}, 'identificationModule': {'nctId': 'NCT01214733', 'briefTitle': 'A Study of RoActemra/Actemra (Tocilizumab) Plus DMARDs in Patients With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Open Label Study of the Safety During Treatment With Tocilizumab (TCZ), in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'ML25321'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: tocilizumab [RoActemra/Actemra]']}], 'interventions': [{'name': 'tocilizumab [RoActemra/Actemra]', 'type': 'DRUG', 'description': '8 mg/kg intravenously every 4 weeks in combination with allowed DMARDs', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7405', 'city': 'Cape Town', 'country': 'South Africa', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '7500', 'city': 'Cape Town', 'country': 'South Africa', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '8001', 'city': 'Cape Town', 'country': 'South Africa', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '1862', 'city': 'Diepkloof', 'country': 'South Africa', 'geoPoint': {'lat': -26.24358, 'lon': 27.9505}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}