Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-30 @ 9:44 PM
Study NCT ID:
NCT05071404
Status:
COMPLETED
Last Update Posted:
2021-11-17
First Post:
2021-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Assessment and Monitoring of Subcutaneous Infliximab Levels.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'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': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-15', 'studyFirstSubmitDate': '2021-09-16', 'studyFirstSubmitQcDate': '2021-09-27', 'lastUpdatePostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perform an efficacy assessment and monitoring of subcutaneous infliximab levels in patients with inflammatory bowel disease.', 'timeFrame': 'Up to 16 weeks.', 'description': 'Number of hospitalizations of patients treated with subcutaneous infliximab suffering from inflammatory bowel disease.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Diseases']}, 'descriptionModule': {'briefSummary': 'Retrospective observational study in which the efficacy of infliximab is studied in patients with inflammatory bowel disease and its subcutaneous levels are monitored.', 'detailedDescription': "Retrospective observational study in which the efficacy of infliximab is studied in patients with inflammatory bowel disease and its subcutaneous levels are monitored.\n\nTreatment is prior to and independent of the patient's participation in the study and is governed by clinical judgment criteria and routine clinical practice, not performing any diagnostic or follow-up intervention that is not routine clinical practice.\n\nPatients are older than 14 years who suffer from inflammatory bowel disease and who receive remsima as routine treatment.\n\nThe source of information will be the patient's medical history."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with inflammatory bowel disease over 14 years of age who are being treated with infliximan sc.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with inflammatory bowel disease.\n* Over 14 years old.\n* Receive Remsin as a treatment for his disease. And always this treatment that the patient is going to receive is governed by the criteria of clinical judgment and routine clinical practice, not performing any diagnostic or follow-up intervention that is not routine clinical practice.\n\nExclusion Criteria:\n\n* Patients with inflammatory bowel disease under 14 years of age.\n* Or older than this age with inflammatory bowel disease who do not attend the established check-ups'}, 'identificationModule': {'nctId': 'NCT05071404', 'acronym': 'Infliximab', 'briefTitle': 'Efficacy Assessment and Monitoring of Subcutaneous Infliximab Levels.', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Pública Andaluza para la gestión de la Investigación en Sevilla'}, 'officialTitle': 'Efficacy Assessment and Monitoring of Subcutaneous Infliximab Levels in Patients With Inflammatory Bowel Disease.', 'orgStudyIdInfo': {'id': 'FIS-INF-2020-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Patients treated with infliximab sc.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '41009', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'overallOfficials': [{'name': 'Federico Arguelles Arias', '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'}}}}