Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-01-11 @ 4:18 AM
Study NCT ID:
NCT02586259
Status:
COMPLETED
Last Update Posted:
2019-11-20
First Post:
2015-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Cortiment® in Patients With Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Israel', 'Switzerland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 378}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-18', 'studyFirstSubmitDate': '2015-10-23', 'studyFirstSubmitQcDate': '2015-10-23', 'lastUpdatePostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical benefit in routine practice, defined as % of patients with clinical improvement ≥ 3-point in Ulcerative Colitis Disease Activity Index (UCDAI) clinical sub-score', 'timeFrame': 'From Day 1 to end of induction treatment (recommended duration up to 8 weeks)'}]}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '31700630', 'type': 'RESULT', 'citation': "Danese S, Hart A, Dignass A, Fiorino G, Louis E, Bonovas S, D'Haens G, Dotan I, Rogler G, Paridaens K, Peyrin-Biroulet L. A multicentre prospective cohort study assessing the effectiveness of budesonide MMX(R) (Cortiment(R)MMX(R)) for active, mild-to-moderate ulcerative colitis. United European Gastroenterol J. 2019 Nov;7(9):1171-1182. doi: 10.1177/2050640619864848. Epub 2019 Jul 17."}, {'pmid': '27239329', 'type': 'DERIVED', 'citation': "Danese S, Hart A, Dignass A, Louis E, D'Haens G, Dotan I, Rogler G, D'Agay L, Iannacone C, Peyrin-Biroulet L. Effectiveness of budesonide MMX (Cortiment) for the treatment of mild-to-moderate active ulcerative colitis: study protocol for a prospective multicentre observational cohort study. BMJ Open Gastroenterol. 2016 May 17;3(1):e000092. doi: 10.1136/bmjgast-2016-000092. eCollection 2016."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate Cortiment® with regard to its use by clinicians in routine clinical practice and its effectiveness and tolerability in a real-life setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from gastroenterologists (hospitals, clinics, office-based).', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women aged ≥ 18 years\n* Outpatients\n* Patients who have been prescribed Cortiment® for the treatment of mild to moderate active ulcerative colitis within a 5 days' time window prior to being included in the study\n* Patients who have received adequate information regarding this non-interventional study and are able to understand and voluntarily sign the Informed Consent\n\nExclusion Criteria:\n\n* Patients with severe active / fulminant ulcerative colitis\n* Patients treated with antibiotics or corticosteroids for the current flare. Use of Antibiotics for other conditions non-related to the gastrointestinal tract, either before enrolment or during the observational period is permitted.\n* History of total / sub-total colectomy\n* Hypersensitivity to the active substance, lecithin (derived soya oil, peanut oil) or to any of the excipients\n* Patients enrolled and involved in an interventional study\n* Patients whom investigators consider inappropriate to participate in the study"}, 'identificationModule': {'nctId': 'NCT02586259', 'acronym': 'CORE Practice', 'briefTitle': 'Effectiveness of Cortiment® in Patients With Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'A Prospective Multi-centre Observational Cohort Study Assessing the Effectiveness of Cortiment® for the Treatment of Mild-to-moderate Active Ulcerative Colitis in Routine Clinical Practice', 'orgStudyIdInfo': {'id': '000217'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cortiment®', 'description': 'Treatment according to routine clinical practice.', 'interventionNames': ['Drug: budesonide MMX®']}], 'interventions': [{'name': 'budesonide MMX®', 'type': 'DRUG', 'otherNames': ['Cortiment®'], 'armGroupLabels': ['Cortiment®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Richmond Hill', 'country': 'Canada', 'facility': 'Digestive Health Clinic (there may be other sites in this country)', 'geoPoint': {'lat': 43.87111, 'lon': -79.43725}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Magen-Darm-Zentrum, Facharztzentrum Eppendorf (there may be other sites in this country)', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': "St. Vincent's University Hospital (there may be other sites in this country)", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Bologna', 'country': 'Italy', 'facility': 'Investigational site (there may be other sites in this country)', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Investigational site (there may be other sites in this country)', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Investigational site (there may be other sites in this country)', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Danderyds sjukhus (there may be other sites in this country)', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Kings College Hospital (there may be other sites in this country)', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Global Clinical Compliance', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}