Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-03-02 @ 7:43 AM
Study NCT ID:
NCT03100734
Status:
COMPLETED
Last Update Posted:
2021-02-05
First Post:
2017-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study to Evaluate the Real-Life Effectiveness of Benepali Following Transition From Enbrel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}], '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'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068800', 'term': 'Etanercept'}], 'ancestors': [{'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 585}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-03', 'studyFirstSubmitDate': '2017-03-29', 'studyFirstSubmitQcDate': '2017-03-29', 'lastUpdatePostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from transition point in Disease Activity Score (DAS-28 score)', 'timeFrame': 'Approximately 3 months after the transition', 'description': 'Score of 28 joints examined'}, {'measure': 'Change from transition point in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score', 'timeFrame': 'Approximately 3 months after the transition', 'description': 'Mean BASDAI score'}], 'secondaryOutcomes': [{'measure': 'Change in the DAS-28 score over time from the value obtained at the Transition Point', 'timeFrame': 'Approximately 3 and 6 months after the transition', 'description': 'Score of 28 joints examined'}, {'measure': 'Proportion of participants with low disease activity or remission over time following Transition Point', 'timeFrame': 'Approximately 3 and 6 months after the transition', 'description': 'Defined as DAS-28 score ≤ 3.2 or ≤ 2.6'}, {'measure': 'Proportion of participants with worsening disease over time following Transition Point', 'timeFrame': 'Approximately 3 and 6 months after the transition', 'description': 'Defined by an increase in DAS-28 of ≥ 1.2, and a minimum DAS score of 3.2'}, {'measure': 'Proportion of participants with an improvement of ≥ 1.2 points in DAS-28 score from Transition Point', 'timeFrame': 'Approximately 3 and 6 months after the transition', 'description': 'Improvement of ≥ 1.2 points in DAS-28 score data collected'}, {'measure': 'Change in the General Health Score (assessed using VAS) over time following transition point', 'timeFrame': 'Approximately 3 and 6 months after the transition', 'description': 'Assessed using Visual Analogue Scale (VAS) over time'}, {'measure': 'Change in the BASDAI score over time from the value obtained at the Transition Point', 'timeFrame': 'Approximately 3 and 6 months after the transition', 'description': 'BASDAI score'}, {'measure': 'Change in Ankylosing Spondylitis Disease Activity Score-Erythrocyte Sedimentation Rate (ASDAS-ESR ) or C-Reactive Protein (CRP) score over time from the value obtained at the Transition Point', 'timeFrame': 'Approximately 3 and 6 months after the transition', 'description': '(ASDAS-ESR ) or (CRP) score'}, {'measure': 'Proportion of participants with worsening disease over time following Transition Point', 'timeFrame': 'Approximately 3 and 6 months after the transition', 'description': 'Defined by an increase in ASDAS score of ≥1.1, and a minimum ASDAS score of 2.1'}, {'measure': 'Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity', 'timeFrame': 'Approximately 3 and 6 months after the transition', 'description': 'Safety surveillance'}, {'measure': 'Change in Patient Global Assessment (PtGA)-Disease activity-VAS score over time from the value obtained at the Transition Point', 'timeFrame': 'Approximately 3 and 6 months after the transition', 'description': 'Assessed using Disease activity-VAS score'}, {'measure': 'Change in Patient Global Assessment - Visual Analogue Scale (PGA PAIN-VAS) score over time from the value obtained at the Transition Point', 'timeFrame': 'Approximately 3 and 6 months after the transition', 'description': 'Assessed using PAIN-VAS score'}, {'measure': 'Change in Patient PGA FATIGUE -VAS score over time from the value obtained at the Transition Point', 'timeFrame': 'Approximately 3 and 6 months after the transition', 'description': 'Assessed using FATIGUE - VAS score'}, {'measure': 'Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score over time from the value obtained at the Transition Point', 'timeFrame': 'Approximately 3 and 6 months after the transition', 'description': 'Assessed using the HAQ-DI score'}, {'measure': 'Change in PAIN-VAS score over time from the value obtained at the Transition Point', 'timeFrame': 'Approximately 3 and 6 months after the transition', 'description': 'Assessed using Pain - VAS score'}, {'measure': 'Change in FATIGUE -VAS score over time from the value obtained at the Transition Point', 'timeFrame': 'Approximately 3 and 6 months after the transition', 'description': 'Assessed using FATIGUE - VAS score'}, {'measure': 'Change in HAQ-DI score over time from the value obtained at the Transition Point', 'timeFrame': 'Approximately 3 and 6 months after the transition', 'description': 'Assessed using the HAQ-DI score'}, {'measure': 'Number of Participants by Demographic Category', 'timeFrame': 'At baseline and approximately 3 and 6 months after the transition'}, {'measure': 'Number of Participants by Relevant Medical History', 'timeFrame': 'At baseline and approximately 3 and 6 months after the transition'}, {'measure': 'Number of Participants by Disease Status', 'timeFrame': 'At baseline and approximately 3 and 6 months after the transition'}, {'measure': 'Number of Participants by Relevant Medication Use', 'timeFrame': 'At baseline and approximately 3 and 6 months after the transition'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Observational', 'Biosimilar', 'Etanercept', 'Benepali', 'Enbrel'], 'conditions': ['Rheumatoid Arthritis', 'Axial Spondyloarthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.clinexprheumatol.org/abstract.asp?a=14829', 'label': 'Manuscript description'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate the effectiveness of Benepali in participants with Rheumatoid Arthritis (RA) and axial spondyloarthritis (axSpA), including participants with Ankylosing Spondylitis (AS) and non-radiographic axSpA, following their transition from treatment with Enbrel.\n\nThe secondary objectives of this study are to describe clinical characteristics of patients transitioned from Enbrel® to Benepali® in routine practice, to evaluate safety during and following the transition from Enbrel to Benepali and to evaluate patient-reported outcomes during and following the transition from Enbrel to Benepali.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants With Rheumatoid Arthritis or Axial Spondyloarthritis to be identified from Primary Care Practice / Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Must have been diagnosed with either rheumatoid arthritis or axial spondyloarthritis, according to local practice\n* Transition from Enbrel to Benepali at the physician's (Investigator's) discretion prior to enrolment into the study\n* Must have been treated with the same dose of Enbrel for at least 6 months prior to transition to Benepali and have at least 1 efficacy data value including but not restricted to DAS-28 or BASDAI during that period\n* Must have a stable disease throughout the 2 month prior to enrolment based on the Investigator's judgement\n* Women of childbearing potential should be advised to use appropriate contraception to avoid becoming pregnant during Benepali therapy and for three weeks after discontinuation of therapy\n\nKey Exclusion Criteria:\n\n* Have any medical conditions that precludes administration of Benepali according to Summary of Product Characteristics (SmPC), such as the following:\n* Hypersensitivity to the Benepali active substance, or to any of the associated excipients\n* Sepsis, or risk of sepsis\n* Active clinically significant local or chronic viral, bacterial or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 2 months prior to enrollment\n* Show any clinical sign or medical condition not allowing for treatment continuation (of etanercept) in the judgment of the Investigator\n* Treatment with another biologic agent\n* Are currently receiving or have previously received any therapies that would preclude administration of Benepali, such as the following:\n* Immunizations with live or live-attenuated vaccines within the last 6 months prior to transition point and throughout the observation period\n* Treatment with investigational agents within the last 6 months prior to transition point and during the period of observation.\n* Any other unspecified reasons that would, in the opinion of the Investigator, make the patient unsuitable for enrollment.\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT03100734', 'acronym': 'BENEFIT', 'briefTitle': 'Observational Study to Evaluate the Real-Life Effectiveness of Benepali Following Transition From Enbrel', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Multicentre Observational Study to Evaluate the Real-Life Effectiveness of Benepali® Following Transition From Enbrel® in Patients With Rheumatoid Arthritis (RA) and Axial Spondyloarthritis (axSpA) - The BENEFIT Study', 'orgStudyIdInfo': {'id': 'EUR-BNP-16-11030'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'With RA', 'description': 'Participants with RA previously treated with Enbrel and transitioned to Benepali', 'interventionNames': ['Biological: Benepali', 'Biological: Enbrel']}, {'label': 'With axSpA', 'description': 'Participants with axSpA previously treated with Enbrel and transitioned to Benepali', 'interventionNames': ['Biological: Benepali', 'Biological: Enbrel']}], 'interventions': [{'name': 'Benepali', 'type': 'BIOLOGICAL', 'description': 'As specified in the treatment arm', 'armGroupLabels': ['With RA', 'With axSpA']}, {'name': 'Enbrel', 'type': 'BIOLOGICAL', 'otherNames': ['etanercept'], 'description': 'As specified in the treatment arm', 'armGroupLabels': ['With RA', 'With axSpA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80639', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biogen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Samsung Bioepis Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}