Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT07100093
Status:
COMPLETED
Last Update Posted:
2025-08-03
First Post:
2025-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective, Multicenter Study on the Association Between Serum Ustekinumab Levels and Clinical, Biological and Endoscopic Remission 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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2025-07-30', 'studyFirstSubmitQcDate': '2025-07-30', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'biological remission', 'timeFrame': 'week 8 and week 16', 'description': 'association between serum levels of ustekinumab and biological remission in induction'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ustekinumab', 'Serum levels', 'Crohn´s disease'], 'conditions': ['Ustekinumab Serum Levels in Patients With Crohn´s Disease']}, 'descriptionModule': {'briefSummary': 'A prospective, non-commercial, multicenter study will be conducted in a cohort of patients initiating induction therapy and a cohort of patients with stable treatment with ustekinumab.', 'detailedDescription': "The present study aims to evaluate the association between serum levels (trough) of Ustekinumab and clinical, biological, endoscopic and radiological response/remission in patients with Crohn's disease, in order to determine threshold levels at induction and maintenance that may be predictors of efficacy.\n\nWorking hypothesis: Serum Ustekinumab levels in Crohn's disease patients are correlated with clinical, biochemical and endoscopic/radiological response/remission.\n\nPatients with an established diagnosis of Crohn's disease by usual criteria (clinical, analytical, endoscopic, radiological and/or histological) who initiate treatment with Ustekinumab (induction cohort) or who are on maintenance treatment with Ustekinumab (maintenance cohort) in a stable dosis (a minimum of 6 months) will be included."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with an established diagnosis of CD based on standard criteria (clinical, laboratory, endoscopic, radiological, and/or histological) who are starting treatment with ustekinumab (induction cohort) or who are undergoing maintenance treatment with ustekinumab (maintenance cohort) on a stable basis (minimum of 6 months) will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with an established diagnosis of CD according to standard criteria (clinical, analytical, endoscopic, radiological, and/or histological) with inflammatory activity, who begin treatment with ustekinumab for remission induction. Activity will be considered to be the presence of clinical activity (Harvey-Bradshaw index ≥5) and/or elevated fecal calprotectin (≥ 250μg/g; ≥100 in cases of surgically treated CD) and/or the presence of endoscopic activity (SES-CD ≥3).\n* Patients with a confirmed diagnosis of CD according to standard criteria (clinical, analytical, endoscopic, radiological, and/or histological) undergoing stable maintenance treatment with ustekinumab for at least 6 months.\n\nExclusion Criteria:\n\n* Patients in whom ustekinumab is indicated for the prevention of post-surgical recurrence.\n* Patients in whom ustekinumab is indicated for the control of perianal disease.\n* Patients in whom ustekinumab is indicated for the control of extraintestinal manifestations.\n* Pregnant women.\n* Patients who are unable to understand the nature of the study, the procedures to be followed, or who are not able to sign an informed consent form.'}, 'identificationModule': {'nctId': 'NCT07100093', 'acronym': 'USTECRO', 'briefTitle': "Prospective, Multicenter Study on the Association Between Serum Ustekinumab Levels and Clinical, Biological and Endoscopic Remission in Patients With Crohn's Disease.", 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario La Paz'}, 'officialTitle': "Prospective, Multicenter Study on the Association Between Serum Ustekinumab Levels and Clinical, Biological and Endoscopic Remission in Patients With Crohn's Disease.", 'orgStudyIdInfo': {'id': 'PI-4732'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Induction', 'description': "Patients with an established diagnosis of Crohn's disease according to the usual criteria (clinical, analytical, endoscopic, radiological and/or histological) with inflammatory activity, who initiate treatment with ustekinumab for induction of remission. Activity will be considered the presence of clinical activity (Harvey-Bradshaw index ≥5) and/or elevation of fecal calprotectin (≥ 250µg/g; ≥100 in case of interventional CD) and/or presence of endoscopic activity (SES-CD ≥3).", 'interventionNames': ['Procedure: Drug serum levels']}, {'label': 'Maintenance', 'description': "Patients with an established diagnosis of Crohn's disease according to usual criteria (clinical, analytical, endoscopic, radiological and/or histological) on maintenance treatment with ustekinumab stably for a minimum of 6 months.", 'interventionNames': ['Procedure: Drug serum levels']}], 'interventions': [{'name': 'Drug serum levels', 'type': 'PROCEDURE', 'description': 'Ustekinumab trough levels (prior to administration of the next dose of the drug) will be determined by enzyme-linked immunoadsorption assay (ELISA) methodology.', 'armGroupLabels': ['Induction', 'Maintenance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario La Paz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'María Dolores Martín Arranz, PhD', 'investigatorAffiliation': 'Hospital Universitario La Paz'}}}}