Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-02-24 @ 8:26 AM
Study NCT ID:
NCT02648035
Status:
COMPLETED
Last Update Posted:
2019-03-25
First Post:
2016-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EMBRACE-SC: Observational Study of Subcutaneous (SC) Tocilizumab Alone or in Combination With Conventional Disease-Modifying Antirheumatic Drugs (cDMARDs) in 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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-22', 'studyFirstSubmitDate': '2016-01-05', 'studyFirstSubmitQcDate': '2016-01-05', 'lastUpdatePostDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Still Receiving Subcutaneous Tocilizumab Therapy at 52 Weeks of Observation', 'timeFrame': 'At 52 weeks'}], 'secondaryOutcomes': [{'measure': 'Health Assessment Questionnaire (HAQ) Score', 'timeFrame': 'At baseline, 24 and 52 weeks'}, {'measure': 'Visual Analog Scale (VAS) Pain Score in a 100 mm Scale', 'timeFrame': 'At baseline, 24 and 52 weeks'}, {'measure': 'Patient Global Assessment of Disease Activity (PtGA) Score in a 100 mm VAS Scale', 'timeFrame': 'At baseline, 24 and 52 weeks'}, {'measure': 'Percentage of Participants with Clinically Significant Changes in Laboratory Values', 'timeFrame': 'At baseline, 24 and 52 weeks'}, {'measure': 'Percentage of Participants on Subcutaneous Tocilizumab Alone Versus Combination Therapy', 'timeFrame': 'At baseline, 24 and 52 weeks'}, {'measure': 'Percentage of Participants Involved in Subcutaneous Tocilizumab Patient Support Programs (PSPs)', 'timeFrame': 'At baseline, 24 and 52 weeks'}, {'measure': 'Percentage of Participants with Adverse Events (AEs), including Serious Adverse Events (SAEs), Non-Serious Adverse Drug Reactions (nsADRs), Injection Site Reactions (ISRs), and Adverse Events of Special Interest (AESIs)', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Percentage of Participants with Infections Events (IEs), Including Serious and Non-Serious IEs', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Percentage of Participants with IEs with Laboratory Abnormalities', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Percentage of Participants with Dose Modification of Methotrexate (MTX) or Other Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) Due to AEs or IEs', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Percentage of Participants with Dose Modification of Subcutaneous Tocilizumab Due to AEs or IEs', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Percentage of Participants on Glucocorticoids (GCs) with AEs', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Disease Activity Score 28 (DAS28)', 'timeFrame': 'At baseline, 24 and 52 weeks'}, {'measure': 'Percentage of Participants with Good/Moderate Response According to the Classification of the European League Against Rheumatism (EULAR)', 'timeFrame': 'At baseline, 24 and 52 weeks'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the percentage of participants treated with subcutaneous (SC) Tocilizumab who are still on treatment after 52 weeks and the factors that play a major role in continuation of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with rheumatoid arthritis for whom the physician has made the decision to start subcutaneous Tocilizumab treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Aged \\>/= 18 years of age with rheumatoid arthritis (RA) for whom the treating physician has made the decision to start subcutaneous (SC) Tocilizumab (TCZ) treatment according to approved label within 4 weeks prior to enrolment.\n\nExclusion Criteria:\n\n* Participants who have been receiving Tocilizumab (TCZ) for more than 4 weeks prior to enrolment.\n* Participants who have received TCZ in past treatments.\n* Participants who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) of starting treatment TCZ SC.\n* Participants with a history of autoimmune disease or of any joint inflammatory disease other than rheumatoid arthritis (RA).'}, 'identificationModule': {'nctId': 'NCT02648035', 'briefTitle': 'EMBRACE-SC: Observational Study of Subcutaneous (SC) Tocilizumab Alone or in Combination With Conventional Disease-Modifying Antirheumatic Drugs (cDMARDs) in Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Multicenter, Post-Marketing, Non-Interventional, Observational Study to Evaluate Persistence to Tocilizumab SC as Monotherapy or in Combination With cDMARD Treatment in RA Patients in Greece: the EMBRACE-SC Study.', 'orgStudyIdInfo': {'id': 'ML29855'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subcutaneous Tocilizumab', 'description': 'Participants receiving treatment for rheumatoid arthritis (RA) with subcutaneous Tocilizumab alone or in combination with conventional disease-modifying antirheumatic drugs (DMARDs) according to approved label.', 'interventionNames': ['Biological: Tocilizumab']}], 'interventions': [{'name': 'Tocilizumab', 'type': 'BIOLOGICAL', 'otherNames': ['ACTEMRA'], 'description': 'Subcutaneous Tocilizumab according to approved label.', 'armGroupLabels': ['Subcutaneous Tocilizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '301 00', 'city': 'Agrinio', 'country': 'Greece', 'facility': 'Private Practice Rheumatology, Merantzis', 'geoPoint': {'lat': 38.62139, 'lon': 21.40778}}, {'zip': '11521', 'city': 'Athens', 'country': 'Greece', 'facility': 'Rheumatology Private Practice', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '14527', 'city': 'Athens', 'country': 'Greece', 'facility': 'General Hospital of Athens KAT, Rheumatology', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Rheumatology Private Practice', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Áno Patísia', 'country': 'Greece', 'facility': 'Private Practice Rheumatology, Stavropoulos', 'geoPoint': {'lat': 38.01811, 'lon': 23.73951}}, {'zip': '731 00', 'city': 'Chania', 'country': 'Greece', 'facility': 'Rheumatology Private Practice', 'geoPoint': {'lat': 35.51124, 'lon': 24.02921}}, {'zip': '66132', 'city': 'Drama', 'country': 'Greece', 'facility': 'Private Practice Rheumatology, Papadimitriou', 'geoPoint': {'lat': 41.15283, 'lon': 24.1473}}, {'zip': '19200', 'city': 'Eleusina', 'country': 'Greece', 'facility': 'Rheumatology Private Practice'}, {'zip': '124 62', 'city': 'Haidari', 'country': 'Greece', 'facility': 'ATTIKO Hospital_4th University Internal Medicine Clinic'}, {'zip': '453 33', 'city': 'Ioannina', 'country': 'Greece', 'facility': 'Private Practice Rheumatology, Georgiadis', 'geoPoint': {'lat': 39.66341, 'lon': 20.85187}}, {'zip': '17673', 'city': 'Kalithea, Athens', 'country': 'Greece', 'facility': 'Rheumatology Private Practice'}, {'zip': '431 00', 'city': 'Karditsa', 'country': 'Greece', 'facility': 'Private Practice Rheumatology, Kotrotsios', 'geoPoint': {'lat': 39.36485, 'lon': 21.92191}}, {'zip': '65500', 'city': 'Kavala', 'country': 'Greece', 'facility': 'General Hospital of Kavala; Rheumatology', 'geoPoint': {'lat': 40.93959, 'lon': 24.40687}}, {'city': 'Kifissia', 'country': 'Greece', 'facility': 'Rheumatology Private Practice', 'geoPoint': {'lat': 38.07438, 'lon': 23.81106}}, {'zip': '412 21', 'city': 'Larissa', 'country': 'Greece', 'facility': 'Private Practice Rehumatology, Ziogas', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'zip': '811 00', 'city': 'Mytilene', 'country': 'Greece', 'facility': 'General Hospital of Mytilini, Rheumatology', 'geoPoint': {'lat': 39.10772, 'lon': 26.55529}}, {'zip': '171 21', 'city': 'Néa Smýrni', 'country': 'Greece', 'facility': 'Private Practice Rheumatology, Trontzas', 'geoPoint': {'lat': 37.94504, 'lon': 23.71416}}, {'zip': '26221', 'city': 'Pátrai', 'country': 'Greece', 'facility': 'Rheumatology Private Practice', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}, {'zip': '26443', 'city': 'Pátrai', 'country': 'Greece', 'facility': 'Olympion Medical Center of Patras, Internal Medicine Clinic', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}, {'zip': '621 22', 'city': 'Serres', 'country': 'Greece', 'facility': 'Private Practice Rheumatology, Psaltis', 'geoPoint': {'lat': 41.08499, 'lon': 23.54757}}, {'zip': '62122', 'city': 'Serres', 'country': 'Greece', 'facility': 'Rheumatology Private Practice', 'geoPoint': {'lat': 41.08499, 'lon': 23.54757}}, {'zip': '54621', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Rheumatology Private Practice', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'General Hospital Agios Pavlos', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Rheumatology Private Practice', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '59100', 'city': 'Véroia', 'country': 'Greece', 'facility': 'Rheumatology Private Practice', 'geoPoint': {'lat': 40.52437, 'lon': 22.20242}}, {'zip': '38221', 'city': 'Volos', 'country': 'Greece', 'facility': 'Rheumatology Private Practice', 'geoPoint': {'lat': 39.36923, 'lon': 22.94769}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}