Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-01-02 @ 11:12 AM
Study NCT ID:
NCT05057832
Status:
UNKNOWN
Last Update Posted:
2021-11-17
First Post:
2021-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determination of Ustekinumab Levels in Patients With Crohn's Disease
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 95}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-15', 'studyFirstSubmitDate': '2021-09-16', 'studyFirstSubmitQcDate': '2021-09-24', 'lastUpdatePostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine breakpoints.', 'timeFrame': 'Up to 44 weeks.', 'description': 'To determine the breakpoints for ustekinumab levels between which clinical remission is expected in patients with inflammatory bowel disease.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Crohn Disease']}, 'descriptionModule': {'briefSummary': 'Observational, prospective, single-center follow-up study carried out with patients from the area of the Virgen de Macarena University Hospital, diagnosed with chronic kidney disease, who started treatment with ustekinumab.', 'detailedDescription': 'Prospective follow-up observational study carried out with patients from the Virgen de Macarena University Hospital, under treatment with ustekinumab in the induction and maintenance phase in order to determine the cut-off points of the ustekinumab levels between which a clinical remission is expected in patients with inflammatory bowel disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients treated with ustekinumab who have had their levels measured will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years.\n* Patients treated with ustekinumab in induction and maintenance phase.\n* They must agree to participate in the clinical study, having previously signed the informed consent.\n\nExclusion Criteria:\n\n* Any patient who does not meet the inclusion criteria previously described and / or who refuses to participate in the study.'}, 'identificationModule': {'nctId': 'NCT05057832', 'acronym': 'Ustekinumab', 'briefTitle': "Determination of Ustekinumab Levels in Patients With Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Fundación Pública Andaluza para la gestión de la Investigación en Sevilla'}, 'officialTitle': "Determination of Ustekinumab Levels in Patients With Crohn's Disease: Use in Clinical Practice", 'orgStudyIdInfo': {'id': 'FIS-UST-2021-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Patients treated with Ustekinumab.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '41009', 'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Federico Arguelles Arla', 'role': 'CONTACT', 'phone': '955 00 80 00'}, {'name': 'Carlos García Pérez', 'role': 'CONTACT', 'email': 'administración.eecc.hvm.sspa@juntadeandalucia.es', 'phone': '955 04 31 27'}], 'facility': 'Hospital Universitario Virgen de Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'centralContacts': [{'name': 'Federico Arguelles Arias', 'role': 'CONTACT', 'email': 'farguelles@telefonica.net', 'phone': '955 00 80 00'}, {'name': 'Carlos García Pérez', 'role': 'CONTACT', 'email': 'administracion.eecc.hvm.sspa@juntadeandalucia.es', 'phone': '955 04 31 27'}], 'overallOfficials': [{'name': 'Federico Arguelles Arlas', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Virgen Macarena'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Pública Andaluza para la gestión de la Investigación en Sevilla', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}