Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2025-12-25 @ 5:49 PM
Study NCT ID:
NCT01384461
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2011-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (ACTIVATE)
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': 251}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2011-06-28', 'studyFirstSubmitQcDate': '2011-06-28', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety: Incidence of adverse events', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Efficacy: Disease Activity Score (DAS 28)', 'timeFrame': '12 months'}, {'measure': 'Pain: Visual Analogue Scale (VAS) pain scale', 'timeFrame': '12 months'}, {'measure': 'Physical Function: Health Assessments Questionnaire (HAQ)', 'timeFrame': '12 months'}, {'measure': 'Incidence of patients with all-cause discontinuation of tocilizumab', 'timeFrame': '12 months'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This observational study will evaluate the safety, tolerability and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with moderate to severe rheumatoid arthritis. Data will be collected for 12 months from patients initiated on treatment with RoActemra/Actemra (8 mg/kg intravenously every 4 weeks) and methotrexate (weekly dose at the discretion of the physician).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with moderate to severe rheumatoid arthritis initiated on treatment with RoActemra/Actemra in combination with methotrexate', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/= 18 years of age\n* Moderate to severe rheumatoid arthritis\n* RoActemra/Actemra treatment initiated by rheumatologist in an Arthritis Center for (up to 2 months prior to study entry)\n\nExclusion Criteria:\n\n* History of severe allergic or anaphylactic reactions or known hypersensitivity to any component of the drug\n* Active, severe infection or history of recurrent clinically significant infection\n* Pregnancy\n* Treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before baseline visit\n* Methotrexate intolerance'}, 'identificationModule': {'nctId': 'NCT01384461', 'briefTitle': 'An Observational Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (ACTIVATE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Open-label, Multicenter Non-interventional Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'ML25503'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1023', 'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1027', 'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1062', 'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '4043', 'city': 'Debrecen', 'country': 'Hungary', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '3300', 'city': 'Eger', 'country': 'Hungary', 'geoPoint': {'lat': 47.90265, 'lon': 20.37329}}, {'zip': '2500', 'city': 'Esztergom', 'country': 'Hungary', 'geoPoint': {'lat': 47.7928, 'lon': 18.74148}}, {'zip': '9023', 'city': 'Győr', 'country': 'Hungary', 'geoPoint': {'lat': 47.68333, 'lon': 17.63512}}, {'zip': '5700', 'city': 'Gyula', 'country': 'Hungary', 'geoPoint': {'lat': 46.65, 'lon': 21.28333}}, {'zip': '8380', 'city': 'Hévíz', 'country': 'Hungary', 'geoPoint': {'lat': 46.79031, 'lon': 17.18408}}, {'zip': '6000', 'city': 'Kecskemét', 'country': 'Hungary', 'geoPoint': {'lat': 46.90618, 'lon': 19.69128}}, {'zip': '2143', 'city': 'Kistarcsa', 'country': 'Hungary', 'geoPoint': {'lat': 47.54757, 'lon': 19.26247}}, {'zip': '3529', 'city': 'Miskolc', 'country': 'Hungary', 'geoPoint': {'lat': 48.10327, 'lon': 20.77806}}, {'zip': '4400', 'city': 'Nyíregyháza', 'country': 'Hungary', 'geoPoint': {'lat': 47.95539, 'lon': 21.71671}}, {'zip': '7632', 'city': 'Pécs', 'country': 'Hungary', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '6724', 'city': 'Szeged', 'country': 'Hungary', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '8000', 'city': 'Székesfehérvár', 'country': 'Hungary', 'geoPoint': {'lat': 47.18995, 'lon': 18.41034}}, {'zip': '5000', 'city': 'Szolnok', 'country': 'Hungary', 'geoPoint': {'lat': 47.18066, 'lon': 20.19835}}, {'zip': '9700', 'city': 'Szombathely', 'country': 'Hungary', 'geoPoint': {'lat': 47.23088, 'lon': 16.62155}}, {'zip': '8200', 'city': 'Veszprém', 'country': 'Hungary', 'geoPoint': {'lat': 47.09327, 'lon': 17.91149}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}