Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-28 @ 4:41 AM
Study NCT ID:
NCT03894956
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2019-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study Evaluating Long-Term Safety and Effectiveness of Humira in Patients With Hidradenitis Suppurativa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017497', 'term': 'Hidradenitis Suppurativa'}], 'ancestors': [{'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D016575', 'term': 'Hidradenitis'}, {'id': 'D013543', 'term': 'Sweat Gland Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-01', 'studyFirstSubmitDate': '2019-03-27', 'studyFirstSubmitQcDate': '2019-03-27', 'lastUpdatePostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants who reported any serious infections during the study', 'timeFrame': 'Up to Week 52', 'description': 'Percentage of participants with incidence of serious infections are reported.'}, {'measure': 'Percentage of participants who reported any adverse drug reactions (ADRs) during the study', 'timeFrame': 'Up to Week 52', 'description': 'ADRs will be coded by Medical Dictionary for Regulatory Activities (MedDRA) dictionary.'}, {'measure': 'Percentage of participants who reported any infections during the study', 'timeFrame': 'Up to Week 52', 'description': 'Percentage of participants with incidence of infections are reported.'}], 'secondaryOutcomes': [{'measure': 'Percentage of participants achieving "Improved" of overall improvement by physician', 'timeFrame': 'Up to Week 52', 'description': 'Percentage of participants achieving overall improvement (improved, unchanged, impossible to evaluate) is assessed by physician.'}, {'measure': 'Percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR)', 'timeFrame': 'Up to week 52', 'description': 'HiSCR is defined as at least 50% reduction in the number of abscesses and inflammatory nodules and no increase in abscess count and no increase in draining fistula count relative to baseline.'}, {'measure': 'Change in C-Reactive Protein (CRP)', 'timeFrame': 'From Baseline to Week 52', 'description': 'CRP values are measured as an inflammatory parameter. Low CRP values mean less inflammation.'}, {'measure': "Change in Patient's global assessment of skin pain", 'timeFrame': 'From Baseline to Week 52', 'description': 'Patient\'s global assessment of skin pain is evaluated on a 11-point scale with 0 for "no pain" and 10 for "worst skin pain imaginable."'}, {'measure': 'Change in Dermatology Life Quality Index (DLQI)', 'timeFrame': 'From Baseline to Week 52', 'description': 'DLQI is a 10-question validated dermatologic disease questionnaire to measure quality of life.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hidradenitis Suppurativa (HS)', 'Humira', 'Adalimumab'], 'conditions': ['Hidradenitis Suppurativa (HS)']}, 'referencesModule': {'references': [{'pmid': '37264993', 'type': 'DERIVED', 'citation': 'Hayashi N, Hayama K, Takahashi K, Kurokawa I, Okazaki M, Kashiwagi T, Iwashita E, Terui T. Real-world safety and effectiveness of adalimumab in patients with hidradenitis suppurativa: A 52-week analysis of a postmarketing surveillance study in Japan. J Dermatol. 2023 Aug;50(8):1034-1044. doi: 10.1111/1346-8138.16835. Epub 2023 Jun 2.'}, {'pmid': '35040156', 'type': 'DERIVED', 'citation': 'Hayashi N, Hayama K, Takahashi K, Kurokawa I, Okazaki M, Kashiwagi T, Iwashita E, Terui T. Real-world safety and effectiveness of adalimumab in patients with hidradenitis suppurativa: 12-week interim analysis of post-marketing surveillance in Japan. J Dermatol. 2022 Apr;49(4):411-421. doi: 10.1111/1346-8138.16297. Epub 2022 Jan 17.'}], 'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=P18-835&Latitude=&Longitude=&LocationName=#additional-resources-section', 'label': 'clinical study report synopsis'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the long-term safety and effectiveness of Humira in patients with Hidradenitis Suppurativa (HS) in real-world clinical practice in Japan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hidradenitis Suppurativa (HS)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who have been prescribed Humira by their treating physician as per routine clinical practice for the treatment of HS.\n\nExclusion Criteria:\n\n* Participants previously treated with Humira.\n* Participants who do not provide consent.'}, 'identificationModule': {'nctId': 'NCT03894956', 'briefTitle': 'Observational Study Evaluating Long-Term Safety and Effectiveness of Humira in Patients With Hidradenitis Suppurativa', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Special Drug Use-Results Survey of Evaluating Safety and Effectiveness of Humira in Long Term Treatment in Patients With Hidradenitis Suppurativa', 'orgStudyIdInfo': {'id': 'P18-835'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with Hidradenitis Suppurativa (HS)', 'description': 'Participants who along with their treating physician have elected for treatment with Humira as per routine clinical practice for the treatment of HS'}]}, 'contactsLocationsModule': {'locations': [{'zip': '446-8602', 'city': 'Anjo-shi', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Anjou Kousei Hospital /ID# 216741'}, {'zip': '491-8558', 'city': 'Ichinomiya-shi', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Ichinomiya Municipal Hospital /ID# 214086'}, {'zip': '480-1195', 'city': 'Nagakute-shi', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Aichi Medical University Hospital /ID# 215312'}, {'zip': '460-0001', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'NHO Nagoya Medical Center /ID# 214406', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '4668560', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Nagoya University Hospital /ID# 214135', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '292-8535', 'city': 'Kisarazu-shi', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Kimitsu Chuo Hospital /ID# 214733'}, {'zip': '791-0295', 'city': 'Toon-shi', 'state': 'Ehime', 'country': 'Japan', 'facility': 'Ehime University Hospital /ID# 214090'}, {'zip': '812-8582', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Kyushu University Hospital /ID# 214092', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '807-8556', 'city': 'Kitakyushu-shi', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Hospital of the University of Occupational and Environmental Health, Japan /ID# 214137'}, {'zip': '738-8503', 'city': 'Hatsukaichi-shi', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'JA Hiroshima General Hospital /ID# 213472'}, {'zip': '065-0033', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Sapporo Higashi Tokushukai Hospital /ID# 213865', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '650-0017', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Kobe University Hospital /ID# 215642', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '651-0095', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Bito Dermatology Clinic /ID# 215316', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '665-0827', 'city': 'Takarazuka-shi', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Takarazuka City Hospital /ID# 214088'}, {'zip': '310-0015', 'city': 'Mito', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Mito Kyodo General Hospital /ID# 214089', 'geoPoint': {'lat': 36.35, 'lon': 140.45}}, {'zip': '232-0024', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Yokohama City University Medical Center /ID# 216740', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '238-8558', 'city': 'Yokosuka-shi', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Yokosuka Kyosai Hospital /ID# 215310'}, {'zip': '783-8505', 'city': 'Nankoku-shi', 'state': 'Kochi', 'country': 'Japan', 'facility': 'Kochi Medical School Hospital /ID# 214091'}, {'zip': '606-8507', 'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Kyoto University Hospital /ID# 215315', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '510-0822', 'city': 'Yokkaichi-shi', 'state': 'Mie-ken', 'country': 'Japan', 'facility': 'Yokkaichi Municipal Hospital /ID# 215641'}, {'zip': '9808574', 'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Tohoku University Hospital /ID# 217830', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '981-8563', 'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Tohoku Rosai Hospital /ID# 214084', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '630-0227', 'city': 'Ikoma-shi', 'state': 'Nara', 'country': 'Japan', 'facility': 'Nara Hospital Kinki University Faculty of Medicine, /ID# 218640'}, {'zip': '700-8558', 'city': 'Okayama', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Okayama University Hospital /ID# 215317', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '903-0215', 'city': 'Nakagami-gun', 'state': 'Okinawa', 'country': 'Japan', 'facility': 'University of the Ryukyus Hospital /ID# 214136'}, {'zip': '596-8501', 'city': 'Kishiwada-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Kishiwada City Hospital /ID# 213471'}, {'zip': '589-8511', 'city': 'Osakasayama-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Kindai University Hospital /ID# 217831'}, {'zip': '565-0871', 'city': 'Suita-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka University Hospital /ID# 215314'}, {'zip': '569-8686', 'city': 'Takatsuki-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Medical and Pharmaceutical University Hospital /ID# 214087'}, {'zip': '350-0495', 'city': 'Iruma-gun', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Saitama Medical University Hospital /ID# 215599'}, {'zip': '350-8550', 'city': 'Kawagoe-shi', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Saitama Medical Center /ID# 218639'}, {'zip': '430-0929', 'city': 'Hamamatsu', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'JA Shizuoka Kohseiren Ensh Hospital /ID# 218160', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}, {'zip': '420-0853', 'city': 'Shizuoka', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Shizuoka City Shizuoka Hospital /ID# 217292', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'zip': '105-8470', 'city': 'Minato-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Toranomon Hospital /ID# 213470'}, {'zip': '169-0073', 'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 214134'}, {'zip': '930-0194', 'city': 'Toyama', 'state': 'Toyama', 'country': 'Japan', 'facility': 'Toyama University Hospital /ID# 214407', 'geoPoint': {'lat': 36.7, 'lon': 137.21667}}, {'zip': '078-8510', 'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Japanese Red Cross Kitami Hospital /ID# 214085'}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}