Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-27 @ 1:45 PM
Study NCT ID:
NCT01218360
Status:
COMPLETED
Last Update Posted:
2015-03-19
First Post:
2010-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of Disease Severity in Participants Diagnosed With Crohn's Disease and Long Term Impact of Treatment Strategies in Participants With Moderate to Severe Crohn's Disease (Protocol P06484)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Greece']}, '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': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-18', 'studyFirstSubmitDate': '2010-10-07', 'studyFirstSubmitQcDate': '2010-10-08', 'lastUpdatePostDateStruct': {'date': '2015-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Percentage of Crohn's disease participants among the study population with a Crohn's Disease Activity Index (CDAI) score of 220-450 at the enrollment to the study.", 'timeFrame': 'Week 0'}, {'measure': 'Record of treatment strategy followed', 'timeFrame': 'Week 0 to 2 years'}, {'measure': 'Change in the CDAI score during the observational period', 'timeFrame': 'Week 0 to 2 years'}], 'secondaryOutcomes': [{'measure': 'Number of surgeries and hospitalizations during the observational period', 'timeFrame': 'Week 0 to 2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Crohn's disease", 'standard-of-care', 'Crohn Disease', "Active Crohn's Disease"], 'conditions': ['Crohn Disease']}, 'descriptionModule': {'briefSummary': "This is an observational study to determine the prevalence of moderate to severe Crohn's disease (CD) among patients with active CD and to evaluate existing therapeutic trends in a standard clinical practice."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Participants with diagnosed active Crohn's Disease who are inadequately controlled with their current therapy", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Must have a diagnosis of active Crohn's Disease irrespective of severity,\n2. Must be inadequately controlled with their current therapy and for whom physician\n\n decides to switch treatment.\n3. Must be between 18 and 65 years of age, of either sex,\n4. Must demonstrate willingness to participate in the study by signing the written informed consent.\n\nExclusion Criteria\n\n* No specific exclusion criteria will be applied to a participant as long as the participant is eligible for the trial"}, 'identificationModule': {'nctId': 'NCT01218360', 'briefTitle': "Observational Study of Disease Severity in Participants Diagnosed With Crohn's Disease and Long Term Impact of Treatment Strategies in Participants With Moderate to Severe Crohn's Disease (Protocol P06484)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': "Observational Study on Disease Severity, Evaluation Tools and the Long Term Impact of Each Treatment Strategy in the Daily Clinical Practice in Patients With Moderate to Severe Active Crohn's Disease (Protocol P06484)", 'orgStudyIdInfo': {'id': 'P06484'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants', 'description': 'All participants enrolled', 'interventionNames': ['Drug: Physician standard-of-care']}], 'interventions': [{'name': 'Physician standard-of-care', 'type': 'DRUG', 'description': "Participants will be treated according to their physician's routine practice and the respective Summary of Product Characteristics (SmPC).", 'armGroupLabels': ['Participants']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}