Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT03339102
Status:
COMPLETED
Last Update Posted:
2021-07-19
First Post:
2017-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-marketing Surveillance Study of Adalimumab (Humira®) for Non-infectious Intermediate, Posterior, or Panuveitis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015864', 'term': 'Panuveitis'}], 'ancestors': [{'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-13', 'studyFirstSubmitDate': '2017-11-08', 'studyFirstSubmitQcDate': '2017-11-08', 'lastUpdatePostDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage (%) of patients reported with serious adverse event', 'timeFrame': 'Up to Week 32', 'description': 'The patients reported with serious adverse event will be collected.'}], 'secondaryOutcomes': [{'measure': 'Change in Visual acuity', 'timeFrame': 'Up to follow-up week 22', 'description': 'The change in visual acuity is assessed from the best corrected visual acuity achieved after the first dose on visual acuity chart in each eye.'}, {'measure': 'Assessing Presence /absence of new active inflammatory chorioretinal lesions', 'timeFrame': 'Up to follow-up week 22', 'description': 'Presence or absence of new active inflammatory chorioretinal lesions is assessed.'}, {'measure': 'Assessing Treatment Response', 'timeFrame': 'Up to follow-up week 22', 'description': 'Treatment response is assessed as improvement, no improvement and aggravation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-infectious intermediate, posterior and panuveitis', 'Post-Marketing Surveillance', 'Humira®'], 'conditions': ['Non-infectious Intermediate, Posterior and Panuveitis']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the safety and effectiveness of Humira® (Adalimumab) for the treatment of non-infectious intermediate, posterior, or panuveitis patients under a routine treatment practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Non-infectious intermediate, posterior and panuveitis (NIIPPU) patients who had been prescribed with Humira® will be registered to the study in accordance with the drug approval status as well as the investigator's clinical judgment.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has been diagnosed with Non-infectious intermediate, posterior and pan-uveitis\n* Patients voluntarily signed a patient authorization \\& informed consent form.\n* Decision on the treatment with Humira® was made prior to any decision to approach the patient to participate in this study.\n* Humira® treatment is indicated as per local Summary of Product Characteristics (SmPC) and professional and/or reimbursement guidelines.\n\nExclusion Criteria:\n\n* A patient who are contraindications to originator adalimumab (Humira®) as listed on the approved Korean label.\n* A patient who is participating on other interventional clinical trials\n* Prior treatment with Humira®, including current course of Humira® started prior to baseline visit assessments.'}, 'identificationModule': {'nctId': 'NCT03339102', 'briefTitle': 'Post-marketing Surveillance Study of Adalimumab (Humira®) for Non-infectious Intermediate, Posterior, or Panuveitis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Post-marketing Surveillance Study of Adalimumab (Humira®) for Non-infectious Intermediate, Posterior, or Panuveitis Patients According to the Standard for "Re-examination of New Drugs"', 'orgStudyIdInfo': {'id': 'P17-176'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants who received Humira®', 'description': 'Non-infectious intermediate, posterior, or panuveitis patients who received Humira®'}]}, 'contactsLocationsModule': {'locations': [{'zip': '49241', 'city': 'Busan', 'state': 'Busan Gwang Yeogsi', 'country': 'South Korea', 'facility': 'Pusan National University Hosp /ID# 202026', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '31151', 'city': 'Cheonan', 'state': 'Chungcheongnam-do', 'country': 'South Korea', 'facility': 'Soon Chun Hyang University Cheonan Hospital /ID# 204551', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'zip': '42415', 'city': 'Daegu', 'state': 'Daegu Gwang Yeogsi', 'country': 'South Korea', 'facility': 'Yeungnam University Med Ctr /ID# 201361', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '13620', 'city': 'Seongnam', 'state': 'Gyeonggido', 'country': 'South Korea', 'facility': 'Seoul National Univ Bundang ho /ID# 201657', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'zip': '16499', 'city': 'Suwon', 'state': 'Gyeonggido', 'country': 'South Korea', 'facility': 'Ajou University Hospital /ID# 201516', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '21388', 'city': 'Bupyeong', 'state': 'Incheon Gwang Yeogsi', 'country': 'South Korea', 'facility': 'HanGil Eye Hospital /ID# 201655', 'geoPoint': {'lat': 34.95861, 'lon': 126.97284}}, {'zip': '54538', 'city': 'Iksan', 'state': 'Jeonrabugdo', 'country': 'South Korea', 'facility': 'Wonkwang University Hospital /ID# 204545', 'geoPoint': {'lat': 35.94389, 'lon': 126.95444}}, {'zip': '06198', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Nune Eye Hospital /ID# 211613', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06273', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'country': 'South Korea', 'facility': 'Gangnam Severance Hospital /ID# 202027', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'country': 'South Korea', 'facility': 'Samsung Medical Center /ID# 201515', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '48972', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Maryknoll Medical Center /ID# 201370', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '28644', 'city': 'Cheongju-si', 'country': 'South Korea', 'facility': 'Chungbuk National Univ Hosp /ID# 204544', 'geoPoint': {'lat': 36.63722, 'lon': 127.48972}}, {'zip': '06023', 'city': 'Gangnam-gu', 'country': 'South Korea', 'facility': "Apgujung St. Mary's Eye Center /ID# 210721"}, {'zip': '10380', 'city': 'Goyang', 'country': 'South Korea', 'facility': 'Inje University Ilsan Paik Hos /ID# 204543', 'geoPoint': {'lat': 36.21689, 'lon': 127.19731}}, {'zip': '61453', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chosun University Hospital /ID# 204542', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital /ID# 201656', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07301', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Kim's Eye Hospital /ID# 205685", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'AbbVie Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}