Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-03-02 @ 6:24 PM
Study NCT ID:
NCT01934933
Status:
COMPLETED
Last Update Posted:
2018-06-18
First Post:
2013-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}, {'id': 'D007249', 'term': 'Inflammation'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}, {'id': 'D000068800', 'term': 'Etanercept'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-14', 'studyFirstSubmitDate': '2013-08-17', 'studyFirstSubmitQcDate': '2013-08-29', 'lastUpdatePostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the SPARCC score of spine and SI joint', 'timeFrame': '52th weeks', 'description': 'the MRI SPARCC score of spine and SI joint on 52th week'}, {'measure': 'ASAS20 response rate', 'timeFrame': '52th week', 'description': 'ASAS20 response rate on 52th week'}], 'secondaryOutcomes': [{'measure': 'ASAS40 response rate', 'timeFrame': '52th week', 'description': 'ASAS40 response rate on 52th week'}, {'measure': 'ASAS70 response', 'timeFrame': '52th week', 'description': 'ASAS70 response rate on 52th week'}, {'measure': 'ASDAS', 'timeFrame': '52th week', 'description': 'ASDAS major improvement ASDAS clinically important improvement on 52th week'}, {'measure': 'mSASSS score of spine', 'timeFrame': '52th week', 'description': 'the mSASSS score of spine on 52th week'}, {'measure': 'Spondyloarthritis Research Consortium of Canada (SPRACC) SI joint structural score (SSS)', 'timeFrame': '52th week', 'description': 'the MRI SPARCC SSS score of spine on 52th week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['inflammation', 'etanercept', 'celecoxib', 'ankylsoing spondylitis'], 'conditions': ['Ankylosing Spondylitis']}, 'referencesModule': {'references': [{'pmid': '36091030', 'type': 'DERIVED', 'citation': 'Tu L, Zhao M, Wang X, Kong Q, Chen Z, Wei Q, Li Q, Yu Q, Ye Z, Cao S, Lin Z, Liao Z, Lv Q, Qi J, Jin O, Pan Y, Gu J. Etanercept/celecoxib on improving MRI inflammation of active ankylosing spondylitis: A multicenter, open-label, randomized clinical trial. Front Immunol. 2022 Aug 26;13:967658. doi: 10.3389/fimmu.2022.967658. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center, open label, randomized clinical trial of etanercept and celecoxib alone/combined treatment in effectiveness and safety on active ankylosing spondylitis (AS). Subjects will be randomly assigned in a 1:1:1 ratio to one of the three groups (celexocib 200mg bid, etanercept 50mg qw, etanercept plus Celecoxib group) for 54 weeks. Primary endpoints are the magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) score of sacroiliac(SI) joint and spine, as well as the Assessment of SpondyloArthritis International Society (ASAS)20 response rate at 52 weeks.', 'detailedDescription': 'A multi-center, open label, randomized clinical trial evaluating the effectiveness and safety of etanercept and celecoxib alone/combined treatment will be conducted on active ankylosing spondylitis (AS) patients. Disease activity is defined as fulfilling three aspects below: BASDAI ≥ 4 or ASDAS≥ 2.1；CRP\\>6 mg/L or ESR 28 mm/1st hour；more than 2 and less than 16 syndesmophyts between cervical spine and lumber spine detected by X-ray. All patients were randomly assigned in a 1:1:1 ratio to one of the three treatment groups：celecoxib 200mg bid，etanercept 50mg qw and combined therapy for 52 weeks. Primary endpoints are the magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) score of sacroiliac(SI) joint and spine, as well as the Assessment of SpondyloArthritis International Society (ASAS) 20 response rate at 52 weeks. Key secondary Endpoints include the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS), Spondyloarthritis Research Consortium of Canada (SPRACC) SI joint structural score (SSS), BASDAI, ASDAS, ASAS40, ASAS70 and ASAS5/6 response rate at 52 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 65 years\n* Meet 1984 NewYork modified criteria for AS\n* BASDAI≥4 or ASDAS score ≥ 2.1\n* CRP\\>6 mg/L or ESR\\>28 mm/h\n* Syndesmophyte quantity ≥2 and \\<16 of spine\n* Sexually active women of childbearing potential must agree and commit to use a medically accepted form of contraception\n* No active or latent tuberculosis infection.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* current or previous history of psoriasis or inflammatory bowel disease.\n* infection with clinical significance within 24 weeks before screening\n* receipt any bio-agents treatment within 12 weeks before screening\n* corticosteroids intra-articular injections in last 3 months before the trial\n* Significant concurrent medical events including: Gastrointestinal ulcer, myocardial infarction within 12 months before the screening visit, unstable angina pectoris, congestive heart failure.\n* Alcohol and drug abuse'}, 'identificationModule': {'nctId': 'NCT01934933', 'briefTitle': 'Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'A Multi-center, Open Label, Random Clinical Trial of Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis', 'orgStudyIdInfo': {'id': '[2013]2-93'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'celebrex', 'description': 'celebrex capsule, 0.2 gram bid, 52 weeks', 'interventionNames': ['Drug: celebrex']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enbrel', 'description': 'etanercept injection, 25mg per injection, 50mg/week, 52 weeks', 'interventionNames': ['Drug: Enbrel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enbrel plus Celebrex', 'description': '50mg/week Enbrel by hypodermic injection plus Celebrex 0.2 gram bid, 52 weeks', 'interventionNames': ['Drug: Enbrel plus Celebrex']}], 'interventions': [{'name': 'celebrex', 'type': 'DRUG', 'otherNames': ['celecoxib'], 'armGroupLabels': ['celebrex']}, {'name': 'Enbrel', 'type': 'DRUG', 'otherNames': ['etanercept'], 'armGroupLabels': ['Enbrel']}, {'name': 'Enbrel plus Celebrex', 'type': 'DRUG', 'otherNames': ['celecoxib plus etanercept'], 'armGroupLabels': ['Enbrel plus Celebrex']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510630', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Jieruo Gu, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Rheumatology ,Third Affiliated Hospital of Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Rheumatology, Third Affiliated Hospital of Sun Yat-sen University', 'investigatorFullName': 'Gu Jieruo', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}