Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2026-02-23 @ 3:01 PM
Study NCT ID:
NCT03505892
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2018-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Clinical REsponses in Ankylosing Spondylitis Patients on Adalimumab Therapy in Taiwan (EAST)
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-19', 'studyFirstSubmitDate': '2018-03-30', 'studyFirstSubmitQcDate': '2018-04-13', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants that achieve 50% improvement of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24', 'timeFrame': '24 Weeks after initiation of Humira therapy', 'description': 'This accounts for participants achieving 50% improvement in BASDAI.'}], 'secondaryOutcomes': [{'measure': 'Percentages of participants who achieve major improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 24', 'timeFrame': '24 Weeks after initiation of Humira therapy', 'description': 'The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation.'}, {'measure': 'Percentages of participants who achieve clinically important improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 24', 'timeFrame': '24 Weeks after initiation of Humira therapy', 'description': 'The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation.'}, {'measure': 'Percentage of participants that achieve 50% improvement of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)', 'timeFrame': "Every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks)", 'description': 'This accounts for participants achieving 50% improvement in BASDAI.'}, {'measure': 'Percentages of participants who achieve clinically important improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS)', 'timeFrame': "Every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks)", 'description': 'The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation.'}, {'measure': 'Percentages of participants who achieve major improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS)', 'timeFrame': "Every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks)", 'description': 'The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation.'}, {'measure': 'Percentages of participants whose disease activity states are inactive per ASDAS score', 'timeFrame': "At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks)", 'description': 'The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation.'}, {'measure': 'Percentages of participants whose disease activity states are moderate per ASDAS score', 'timeFrame': "At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks)", 'description': 'The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation.'}, {'measure': 'Changes of the frequency of overall extra-articular manifestations (EAM) of interest', 'timeFrame': "At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks)", 'description': 'The change of the frequency of overall extra-articular manifestations (EAM) will be assessed.'}, {'measure': 'Changes of the respective frequency of each EAM', 'timeFrame': "At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks)", 'description': 'The changes of the respective frequency of each EAM will be assessed.'}, {'measure': 'Changes in the percentage of participants who have enthesitis of the plantar fascia or Achilles tendon', 'timeFrame': "At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks)", 'description': 'The change in the percentage of participants who have enthesitis of the plantar fascia or Achilles tendon will be assessed.'}, {'measure': 'Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)', 'timeFrame': "At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks)", 'description': 'The change in MASES score will be assessed.'}, {'measure': 'Change in Tender Joint Counts (TJC)', 'timeFrame': "At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks)", 'description': 'The change of TJC (0-46), in participants who had peripheral arthritis (≥1 swollen joint) at baseline will be assessed.'}, {'measure': 'Change in Swollen Joint Counts (SJC)', 'timeFrame': "At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks)", 'description': 'The change of SJC (0-44), in participants who had peripheral arthritis (≥1 swollen joint) at baseline will be assessed.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ankylosing Spondylitis (AS)', 'Adaliumumab', 'Humira'], 'conditions': ['Ankylosing Spondylitis (AS)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=P16-326#additional-resources-section', 'label': 'clinical study report synopsis'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this prospective observational study is to explore 1-year clinical response via both Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) after initiation of adalimumab therapy in AS patients from routine clinical practices in Taiwan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with Ankylosing Spondylitis (AS) after the initiation of adalimumab therapy in the real-world practices in Taiwan.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with confirmed AS.\n* Participant will start adalimumab as treatment\n* Participant must provide the written authorization form and agree to provide personal and/or health data prior to the entry into the study.\n\nExclusion Criteria:\n\n* Participant has been treated with any investigational drug or biologic within a minimum of 30 days or five half-lives (whichever is longer) of the drug prior to the Baseline Visit.\n* Participants who fulfill any of the contraindications as per Humira label in Taiwan.'}, 'identificationModule': {'nctId': 'NCT03505892', 'acronym': 'EAST', 'briefTitle': 'A Study to Investigate the Clinical REsponses in Ankylosing Spondylitis Patients on Adalimumab Therapy in Taiwan (EAST)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Real-world, Prospective, Observational Study to Investigate the Clinical REsponses in Ankylosing Spondylitis Patients on Adalimumab Therapy in Taiwan (EAST)', 'orgStudyIdInfo': {'id': 'P16-326'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants receiving adalimumab', 'description': 'Participants with AS receiving adalimumab'}]}, 'contactsLocationsModule': {'locations': [{'zip': '970', 'city': 'Hualien City', 'country': 'Taiwan', 'facility': 'Hualien Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation', 'geoPoint': {'lat': 23.97694, 'lon': 121.60444}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}