Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT00723905
Status:
COMPLETED
Last Update Posted:
2013-01-15
First Post:
2008-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Remicade Infusion Management Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], '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'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1630}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-14', 'studyFirstSubmitDate': '2008-07-25', 'studyFirstSubmitQcDate': '2008-07-25', 'lastUpdatePostDateStruct': {'date': '2013-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Type and frequency of infusion reactions', 'timeFrame': 'Up to 7 years'}, {'measure': 'Pre-infusion treatments and efficacy', 'timeFrame': 'Up to 7 years'}, {'measure': 'Infusion reaction management approaches', 'timeFrame': 'Up to 7 years'}, {'measure': 'The number of subjects with adverse events', 'timeFrame': 'Up to 7 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Crohn's Disease, Rheumatoid Arthritis"], 'conditions': ['Crohn Disease', 'Arthritis, Rheumatoid']}, 'referencesModule': {'references': [{'pmid': '26077415', 'type': 'DERIVED', 'citation': 'Choquette D, Faraawi R, Chow A, Rodrigues J, Bensen WJ, Nantel F. Incidence and Management of Infusion Reactions to Infliximab in a Prospective Real-world Community Registry. J Rheumatol. 2015 Jul;42(7):1105-11. doi: 10.3899/jrheum.140538. Epub 2015 Jun 15.'}]}, 'descriptionModule': {'briefSummary': 'Janssen Inc. plans to collect data on about 3000 to 5000 infliximab infusions per year, starting in the third quarter of 2005. It is expected that about 12 sites from the Remicade Infusion Network (R.I.N.) will participate. This registry will be a multicentre, prospective, observational program that will gather and analyze data on subjects being treated with infliximab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The data captured and reported in this registry will reflect a "real world" approach to the treatment of Rheumatoid Arthritis and Crohn\'s Disease with infliximab.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is a good candidate to receive infliximab as per the Product Monograph\n* Subject is prescribed infliximab by an appropriate physician\n* Subject receives infusion in a community infusion centre.\n* Subject has signed the approved consent form.\n\nExclusion Criteria:\n\n* Not specified in the protocol'}, 'identificationModule': {'nctId': 'NCT00723905', 'acronym': 'RemiTRAC', 'briefTitle': 'Remicade Infusion Management Program', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Inc.'}, 'officialTitle': 'Remicade Infusion Management Program', 'orgStudyIdInfo': {'id': 'CR100746'}, 'secondaryIdInfos': [{'id': 'P04466', 'type': 'OTHER', 'domain': 'Janssen Inc.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Pointe-Claire', 'country': 'Canada', 'geoPoint': {'lat': 45.44868, 'lon': -73.81669}}], 'overallOfficials': [{'name': 'Janssen Inc. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}