Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-01 @ 12:07 AM
Study NCT ID:
NCT03193957
Status:
COMPLETED
Last Update Posted:
2017-10-13
First Post:
2017-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects 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': '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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-12', 'studyFirstSubmitDate': '2017-06-19', 'studyFirstSubmitQcDate': '2017-06-20', 'lastUpdatePostDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in Injection site pain score at immediately post injection (within 1 minute)', 'timeFrame': 'at Week 1 and Week 3', 'description': 'The change in injection site pain score at immediately post injection (within 1 minute) using an 11-point visual numeric scale'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '31372961', 'type': 'DERIVED', 'citation': 'Rho YH, Rychlewska-Hanczewska A, Sliwowska B, Kim TH. Usability of Prefilled Syringe and Autoinjector for SB4 (An Etanercept Biosimilar) in Patients with Rheumatoid Arthritis. Adv Ther. 2019 Sep;36(9):2287-2295. doi: 10.1007/s12325-019-01027-z. Epub 2019 Aug 1.'}]}, 'descriptionModule': {'briefSummary': 'A study comparing the usability of the Autoinjector and Pre-filled Syringe of SB4 in Subjects with Rheumatoid Arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects are male or female aged 18-55 years at the time of signing the informed consent form.\n\nExclusion Criteria:\n\n* Have been treated previously with monoclonal antibody agent including any tumour necrosis factor inhibitor except SB4.'}, 'identificationModule': {'nctId': 'NCT03193957', 'briefTitle': 'An Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Samsung Bioepis Co., Ltd.'}, 'officialTitle': 'An Open-label, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'SB4-G21-RA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SB4', 'description': 'SB4 (etanercept) 50 mg/mL', 'interventionNames': ['Drug: Etanercept', 'Device: Autoinjector']}], 'interventions': [{'name': 'Etanercept', 'type': 'DRUG', 'description': 'Etanercept PFS and Autoinjector', 'armGroupLabels': ['SB4']}, {'name': 'Autoinjector', 'type': 'DEVICE', 'description': 'Autoinjector', 'armGroupLabels': ['SB4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Poznan', 'country': 'Poland', 'facility': 'AI Centrum Medyczne', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Bioepis Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}