Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-02-13 @ 12:29 PM
Study NCT ID:
NCT01718951
Status:
COMPLETED
Last Update Posted:
2015-05-12
First Post:
2012-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Golimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}], 'ancestors': [{'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D000844', 'term': 'Ankylosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529000', 'term': 'golimumab'}, {'id': 'D000077268', 'term': 'Pamidronate'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-11', 'studyFirstSubmitDate': '2012-10-29', 'studyFirstSubmitQcDate': '2012-10-31', 'lastUpdatePostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of SpondyloArthritis international Society criteria (ASAS)-20 response response', 'timeFrame': 'week 48', 'description': 'Proportion of patients who achieve the Assessment of SpondyloArthritis international Society criteria (ASAS)-20 response'}], 'secondaryOutcomes': [{'measure': 'Changes in MRI spinal inflammation scores', 'timeFrame': 'week 24 and 48', 'description': 'Changes in MRI spinal inflammation scores'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['spondyloarthropathy', 'ankylosing spondylitis'], 'conditions': ['Spondyloarthropathy']}, 'descriptionModule': {'briefSummary': 'To compare the efficacy of golimumab with pamidronate in the treatment of axial spondyloarthropathy', 'detailedDescription': 'To compare the efficacy of golimumab with pamidronate in the treatment of non-radiological axial spondyloarthropathy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects greater than 18 years of age\n2. Fulfilling the latest classification criteria for axial spondyloarthropathy\n3. Active spondylitis as defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of more than 4 despite treatment with non-steroid anti-inflammatory drugs for more than 3 months\n\nExclusion Criteria:\n\n1. Major surgery (including joint surgery) within 8 weeks prior to study entry\n2. History of treatment with anti-tumor necrosis factor agents or any investigational therapies within 12 months of study entry\n3. Immunization with a live/attenuated vaccine within 4 weeks prior to study entry\n4. Active current bacterial, viral, fungal, mycobacterial or other infections at study entry\n5. Chronic hepatitis B or hepatitis C carriers\n6. History of malignancies, including solid tumors and hemic malignancies\n7. History of congestive heart failure\n8. History of demyelinating disorders\n9. History of peripheral neuropathy\n10. Pregnant women or lactating mothers\n11. Baseline liver parenchymal enzymes elevated to more than 2 times normal\n12. Absolute lymphocyte count less than 500/mm3\n13. Serum creatinine level of more than 200umol/L'}, 'identificationModule': {'nctId': 'NCT01718951', 'briefTitle': 'Golimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Trial', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tuen Mun Hospital'}, 'officialTitle': 'Golimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CREC/769/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'golimumab', 'description': 'golimumab 50mg subcutaneous every 4 weeks', 'interventionNames': ['Drug: golimumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pamidronate', 'description': 'Pamidronate (60mg) intravenously every 4 weeks', 'interventionNames': ['Drug: Pamidronate']}], 'interventions': [{'name': 'golimumab', 'type': 'DRUG', 'otherNames': ['Simponi'], 'description': 'golimumab', 'armGroupLabels': ['golimumab']}, {'name': 'Pamidronate', 'type': 'DRUG', 'otherNames': ['Aridia'], 'description': 'pamidronate', 'armGroupLabels': ['pamidronate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Tuen Mun Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tuen Mun Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Chi Chiu Mok', 'investigatorAffiliation': 'Tuen Mun Hospital'}}}}