Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-24 @ 6:45 PM
Study NCT ID:
NCT03942120
Status:
COMPLETED
Last Update Posted:
2025-04-27
First Post:
2019-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Marketing Surveillance for Crohn's Disease Participants Treated With Stelara (Ustekinumab)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069549', 'term': 'Ustekinumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 685}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2019-05-07', 'studyFirstSubmitQcDate': '2019-05-07', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events', 'timeFrame': 'Approximately up to 3 years', 'description': 'An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.'}, {'measure': "Change from Baseline in Crohn's Disease Activity Index (CDAI) Score", 'timeFrame': 'Baseline up to 3 years', 'description': "CDAI is a scoring system to assess the symptoms of participants with Crohn's disease (CD). It consists of 8 different CD-related factors that are summed after adjustment with a weighting factor. These 8 variables are: extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid stools, abdominal pain/cramping, and general well-being. CDAI total score ranges from 0 to 900 and a decrease over time indicates improvement in disease activity."}, {'measure': 'Change from Baseline in C-reactive Protein (CRP) Concentration', 'timeFrame': 'Baseline up to 3 years', 'description': 'Change from baseline in CRP concentration will be assessed.'}, {'measure': 'Change from Baseline in Harvey-Bradshaw Index (HBI) Score', 'timeFrame': 'Baseline up to 3 years', 'description': "HBI is a shorter and simpler alternative version of CDAI which consists of five parameters that allow physicians to quickly categorize the severity of Crohn's disease and detect remission. The 5 parameters are: general well-being (0-4, where higher score means lower well-being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day (score 1 per movement), abdominal mass (0=none, 1=dubious, 2=definite, 3=definite and tender), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools per day and number of complications, where higher scores indicate more severe disease and, score is presented as: less than (\\<)5 (remission), 5-7 (mild disease), 8-16 (moderate disease), and greater than (\\>)16 (severe disease)."}, {'measure': 'Change from Baseline in Fecal Calprotectin Level', 'timeFrame': 'Baseline up to 3 years', 'description': 'Change from baseline in fecal calprotectin levels will be assessed. Elevated calprotectin level in the stool indicates that inflammation is present in the intestine and the degree of elevation is associated with the severity of the inflammation.'}, {'measure': "Change from Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD)", 'timeFrame': 'Baseline up to 3 years', 'description': "SES-CD is a simplified endoscopic scoring system to evaluate Crohn's disease activity developed as an alternative to Crohn's disease endoscopic index of severity (CDEIS). It assesses the size of mucosal ulcers, the ulcerated surface, the endoscopic extension and the presence stenosis. Each endoscopic component is scored from 0 to 3 for each segment, and a total score is derived from the sum of all the component scores (range, 0 \\[remission\\] to 60 \\[the most severe endoscopic activity\\])."}, {'measure': 'Change from Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score', 'timeFrame': 'Baseline up to 3 years', 'description': 'SIBDQ is a simple, validated 10-item self-reported questionnaire for participants with inflammatory bowel disease to evaluate participant-reported outcomes in 4 domains- digestive symptoms (3 items), systemic symptoms (2 items), emotional disturbance (3 items), and social function (2 items). Participants rate each item on a 7-point Likert scale (1=all of the time; 2=most of the time; 3=a good bit of the time; 4=some of the time; 5=a little bit of the time; 6=hardly any of the time; 7=none of the time). Total score is calculated by adding the scores from each domain; the total score ranges from 10 to 70, where minimum score =10 (poor quality of life) and maximum score =70 (good quality of life).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Crohn Disease']}, 'referencesModule': {'references': [{'pmid': '39096895', 'type': 'DERIVED', 'citation': "Lee CK, Moon W, Chun J, Kim ES, Kim HW, Yoon H, Kim HS, Lee YJ, Choi CH, Jung Y, Park SC, Song GA, Lee JH, Jung ES, Kim Y, Jung SY, Choi JM, Ye BD. One-year Safety and Effectiveness of Ustekinumab in Patients With Crohn's Disease: The K-STAR Study. Inflamm Bowel Dis. 2025 May 12;31(5):1306-1316. doi: 10.1093/ibd/izae171."}]}, 'descriptionModule': {'briefSummary': "The purpose of post-marketing surveillance (PMS) is to assess the safety and effectiveness of ustekinumab (Stelara) for Crohn's disease participants under real world clinical practice."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "The eligible participants who are being prescribed ustekinumab (Stelara) for the treatment of Crohn's disease indication will be part of this study.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants who are administered with Stelara for the first time for the indication of Crohn's disease in accordance with the label\n* Participants must sign a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements\n\nExclusion Criteria:\n\n\\- Have contraindication to Stelara in accordance to the label"}, 'identificationModule': {'nctId': 'NCT03942120', 'acronym': 'STELARA CD PMS', 'briefTitle': "Post-Marketing Surveillance for Crohn's Disease Participants Treated With Stelara (Ustekinumab)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Korea, Ltd., Korea'}, 'officialTitle': "Post-Marketing Surveillance for Crohn's Disease Patients Treated With STELARA", 'orgStudyIdInfo': {'id': 'CR108610'}, 'secondaryIdInfos': [{'id': 'CNTO1275CRD4029', 'type': 'OTHER', 'domain': 'Janssen Korea, Ltd., Korea'}]}, 'armsInterventionsModule': {'armGroups': [{'label': "Participants with Crohn's Disease", 'description': "Participants that are diagnosed with Crohn's disease will be observed in this study who are being treated with ustekinumab under real world clinical practice. Only data available per clinical practice will be collected within this study.", 'interventionNames': ['Drug: Ustekinumab']}], 'interventions': [{'name': 'Ustekinumab', 'type': 'DRUG', 'otherNames': ['Stelara'], 'description': 'Participants treated with ustekinumab under real world clinical practice will be observed in this study. No study drug will be administered as a part of this study.', 'armGroupLabels': ["Participants with Crohn's Disease"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '47392', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '48108', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Haeundae Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '48108', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Kosin University Gospel Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '48265', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Good Gangan Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '49241', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '602 812', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Dong-A University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '51353', 'city': 'Changwon', 'country': 'South Korea', 'facility': 'Samsung ChangWon Hospital', 'geoPoint': {'lat': 35.22806, 'lon': 128.68111}}, {'zip': '51472', 'city': 'Changwonsi', 'country': 'South Korea', 'facility': 'Changwon Kyunngsang University Hospital'}, {'city': 'Cheonan', 'country': 'South Korea', 'facility': 'Soonchunhyang University Cheonan Hospital', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'zip': '31116', 'city': 'Cheonan-si', 'country': 'South Korea', 'facility': 'Dankook University Hospital'}, {'zip': '24253', 'city': 'Chuncheon', 'country': 'South Korea', 'facility': 'Hallym University Chuncehon Medical Center', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'zip': '24289', 'city': 'Chuncheon', 'country': 'South Korea', 'facility': 'Kangwon National University Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'zip': '41199', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Daegu Fatima Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '41404', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyongpook national university Medical center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '41404', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Chilgok Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '41944', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '42415', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Yeungnam University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '42601', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '42644', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Koo Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '302-718', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Konyang University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '35015', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '501-757', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chunnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '13620', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '15355', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Korea University Ansan Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '18450', 'city': 'Hwaseong-si', 'country': 'South Korea', 'facility': 'Hallym University Dongtan Sacred Heart Hospital', 'geoPoint': {'lat': 37.20682, 'lon': 126.8169}}, {'zip': '52727', 'city': 'Jinju', 'country': 'South Korea', 'facility': 'GyeongSang National University Hospital', 'geoPoint': {'lat': 35.19278, 'lon': 128.08472}}, {'city': 'Kyunggido', 'country': 'South Korea', 'facility': 'Bucheon Soonchunhyang Hospital'}, {'zip': '13620', 'city': 'Seongnam', 'country': 'South Korea', 'facility': "The Catholic Univ. of Korea, DaeJeon St. Mary's Hospital", 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'zip': '412-723', 'city': 'Seongnam', 'country': 'South Korea', 'facility': 'CHA Bundang Medical Center, CHA University', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'zip': '02447', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03181', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '04401', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Soonchunhyang University Seoul Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hallym University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'The Catholic University of Korea Seoul St Mary s Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06973', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Chung-Ang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '102-1703', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'KyungHee University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei University Severance Hospital - Dept.of Internal Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-720', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '158-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Ewha Woman's University Seoul Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '50612', 'city': 'Yangsan', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}], 'overallOfficials': [{'name': 'Janssen Korea, Ltd., Korea Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Korea, Ltd., Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Korea, Ltd., Korea', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}