Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-03-11 @ 5:24 PM
Study NCT ID:
NCT02489760
Status:
UNKNOWN
Last Update Posted:
2016-01-20
First Post:
2015-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}], 'ancestors': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068879', 'term': 'Adalimumab'}, {'id': 'D000068800', 'term': 'Etanercept'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-18', 'studyFirstSubmitDate': '2015-06-27', 'studyFirstSubmitQcDate': '2015-07-01', 'lastUpdatePostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bath AS disease activity index (BASDAI)', 'timeFrame': 'weeks 8', 'description': 'The score of BASDAI on weeks 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Etanercept', 'Adalimumab', 'Ankylosing Spondylitis', 'Switch Study'], 'conditions': ['Ankylosing Spondylitis']}, 'referencesModule': {'references': [{'pmid': '33195311', 'type': 'DERIVED', 'citation': 'Wei JC, Tsou HK, Leong PY, Chen CY, Huang JX. Head-to-Head Comparison of Etanercept vs. Adalimumab in the Treatment of Ankylosing Spondylitis: An Open-Label Randomized Controlled Crossover Clinical Trial. Front Med (Lausanne). 2020 Oct 30;7:566160. doi: 10.3389/fmed.2020.566160. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'To determine the safety and efficacy of switch effects to adalimumab in etanercept-treated AS patients.', 'detailedDescription': 'This single-centre, open-labeled randomized controlled study will evaluate the safety and efficacy of adalimumab in etanercept-treated Ankylosing Spondylitis(AS) patients.\n\nThirty patients will be enrolled and randomized equally into two arms.\n\nDosage and Administration：For standard dose(etanercept 50 mg weekly) treated patients, the treatment arm will receive adalimumab 40 mg subcutaneously biweekly for 8 weeks. The control arm will continue etanercept 25 mg subcutaneously twice a week for 8 weeks. At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously biweekly for another 8 weeks.For half dose(etanercept 25 mg weekly) treated patients, the treatment arm will receive adalimumab 40 mg subcutaneously monthly for 8 weeks. The control arm will continue etanercept 25 mg subcutaneously weekly for 8 weeks. At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously monthly for another 8 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of AS, as defined by 1984 Modified New York Criteria for AS.\n* Stable background therapy as non-steroid anti-inflammatory for 2 weeks.\n* Stable glucocorticoid for 4 weeks.\n* Stable disease-modifying anti-rheumatic drugs, eg. sulphasalazine, methotrexate for 8 weeks.\n* Stable anti-TNF biologics for 4 weeks.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Serum creatinine ≥3.0 mg/dl.\n* GPT≥5 times the laboratory's upper limit of normal.\n* Pregnant or breast-feeding women."}, 'identificationModule': {'nctId': 'NCT02489760', 'briefTitle': 'Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch Study', 'organization': {'class': 'OTHER', 'fullName': 'Chung Shan Medical University'}, 'officialTitle': 'Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch Study', 'orgStudyIdInfo': {'id': 'CS08019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adalimumab switch to Etanercept', 'description': 'At week 8, the treatment arm will be switched to etanercept 25 mg subcutaneously biweekly for another 8 weeks.', 'interventionNames': ['Biological: Adalimumab', 'Biological: Etanercept']}, {'type': 'EXPERIMENTAL', 'label': 'Etanercept switch to Adalimumab', 'description': 'At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously biweekly for another 8 weeks.', 'interventionNames': ['Biological: Adalimumab', 'Biological: Etanercept']}], 'interventions': [{'name': 'Adalimumab', 'type': 'BIOLOGICAL', 'otherNames': ['Humira'], 'description': 'The treatment arm will receive adalimumab 40 mg subcutaneously biweekly', 'armGroupLabels': ['Adalimumab switch to Etanercept', 'Etanercept switch to Adalimumab']}, {'name': 'Etanercept', 'type': 'BIOLOGICAL', 'otherNames': ['Enbrel'], 'description': 'The control arm will continue etanercept 25 mg subcutaneously twice a week', 'armGroupLabels': ['Adalimumab switch to Etanercept', 'Etanercept switch to Adalimumab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Chung Shan Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Wei C- C, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chung Shan Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung Shan Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Etanercept versus Adalimumab in the Treatment of Patients with Ankylosing Spondylitis. A Switch Study.', 'investigatorFullName': 'GCRC', 'investigatorAffiliation': 'Chung Shan Medical University'}}}}