Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-10 @ 5:14 PM
Study NCT ID:
NCT02377258
Status:
COMPLETED
Last Update Posted:
2022-08-03
First Post:
2015-02-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IBD Cancer and Serious Infection in Europe
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13262}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2015-02-26', 'studyFirstSubmitQcDate': '2015-02-26', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients.', 'timeFrame': '3 years', 'description': 'assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients.'}], 'secondaryOutcomes': [{'measure': 'Disease modification', 'timeFrame': '3 Years', 'description': 'To investigate prospectively the impact of anti-TNF based strategies on the natural history of IBD and their potential for disease modification by collecting validated surrogate markers such as mucosal healing and disease complications such as bowel damage (strictures, fistulas, abscess), surgeries, and hospitalisations'}, {'measure': 'ePRO', 'timeFrame': '3 Years', 'description': 'To assess the evolution of Patient Reported Outcome (ePRO) on a yearly basis and the impact of anti-TNF agents on ePRO in IBD'}, {'measure': 'Benefit-Risk', 'timeFrame': '3 Years', 'description': 'To evaluate the benefit-risk ratio of strategies based on an earlier and wider use of anti-TNF therapy for IBD'}, {'measure': 'Cost Efficacy', 'timeFrame': '3 Years', 'description': 'To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lymphoma', 'safety', 'biologic therapies'], 'conditions': ['IBD']}, 'referencesModule': {'references': [{'pmid': '41139534', 'type': 'DERIVED', 'citation': "Peyrin-Biroulet L, Nazar M, Sheahan A, Geldhof A, Azzabi A, Baert F, Mailhat C, Rousseau H, Rahier JF, Beaugerie L. Long-term safety of ustekinumab in Crohn's disease: Descriptive analysis from an observational post-authorisation safety study using I-CARE cohort data. Dig Liver Dis. 2025 Oct 25:S1590-8658(25)01128-4. doi: 10.1016/j.dld.2025.09.026. Online ahead of print."}, {'pmid': '36152897', 'type': 'DERIVED', 'citation': 'Peyrin-Biroulet L, Rahier JF, Kirchgesner J, Abitbol V, Shaji S, Armuzzi A, Karmiris K, Gisbert JP, Bossuyt P, Helwig U, Burisch J, Yanai H, Doherty GA, Magro F, Molnar T, Lowenberg M, Halfvarson J, Zagorowicz E, Rousseau H, Baumann C, Baert F, Beaugerie L; I-CARE Collaborator Group. I-CARE, a European Prospective Cohort Study Assessing Safety and Effectiveness of Biologics in Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2023 Mar;21(3):771-788.e10. doi: 10.1016/j.cgh.2022.09.018. Epub 2022 Sep 22.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of I-CARE is to assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients.\n\nWe will stratify the risk of cancers and serious infections according to IBD phenotype and disease activity (clinical, radiologic and endoscopic).', 'detailedDescription': 'The four main secondary objectives of the I-CARE project are:\n\n* To investigate prospectively the impact of anti-TNF based strategies on the natural history of IBD and their potential for disease modification by collecting validated surrogate markers such as mucosal healing and disease complications such as bowel damage (strictures, fistulas, abscess), surgeries, and hospitalizations\n* To assess the evolution of Patient Reported Outcome (ePRO) on a yearly basis and the impact of anti-TNF agents on ePRO in IBD\n* To evaluate the benefit-risk ratio of strategies based on an earlier and wider use of anti-TNF therapy for IBD\n* To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD 5-ASA and Steroids across Europe At least 5000 IBD patients treated with 5-ASA or Steroids and FU for 3 years\n\n * use of 5-ASA and efficacy (persistence, switch, mucosal healing etc.)\n * chemoprevention of CRC: first study that will specifically and accurately address this question\n * use of budesonide mmx and efficacy (clinical efficacy, mucosal healing and potential for disease modification)\n * safety of steroids (infections etc)\n\nSTUDY DESIGN:\n\n22 patients per investigator. Each Investigator will recruit and enrol 20 patients with imposed treatment stratification : Group 1: 5 without previous or ongoing exposure to IS or biologics, (5 ASA and Steroids are allowed) Group 2: 5 with on-going anti-TNF monotherapy Group 3: 5 with thiopurines monotherapy Group 4: 5 with on-going combination therapy Group 5: 2 patients on vedolizumab (on vedolizumab alone and 1 on combination therapy) (optionnal) Group 6: 5 patients treated with ustekinumab with or without any concomitant medications. (optional)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '17600 patients in 17 European countries, enrolled by 800 investigators (22 subjects per investigator)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CD or UC\n* Capable to complete eDiary on a regular basis, and have access to smartphone or internet\n* Accepted to participate and provide personal information (name, phone and email) for contact\n* Accepted to be contacted by study coordinators on a regular basis for follow up with missing information\n\nExclusion Criteria:\n\n* Unable to sign consent\n* Unable to access internet or use smartphone\n* Refused to sign consent or to provide personal identification information'}, 'identificationModule': {'nctId': 'NCT02377258', 'acronym': 'I-CARE', 'briefTitle': 'IBD Cancer and Serious Infection in Europe', 'organization': {'class': 'OTHER', 'fullName': "Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives"}, 'officialTitle': 'IBD Cancer and Serious Infection in Europe', 'orgStudyIdInfo': {'id': 'GETAID 2015-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'without previous or ongoing exposure to IS or biologics, (5ASA and Steroids are allowed)', 'interventionNames': ['Other: Non Interventional']}, {'label': '2', 'description': 'with on-going anti-TNF monotherapy', 'interventionNames': ['Other: Non Interventional']}, {'label': '3', 'description': 'with thiopurines monotherapy', 'interventionNames': ['Other: Non Interventional']}, {'label': '4', 'description': 'with on-going combination therapy', 'interventionNames': ['Other: Non Interventional']}, {'label': '5', 'description': 'patients on vedolizumab (1 on vedolizumab alone and 1 on combination therapy)', 'interventionNames': ['Other: Non Interventional']}, {'label': '6', 'description': 'patients on ustekinumab (alone or on combination therapy)', 'interventionNames': ['Other: Non Interventional']}], 'interventions': [{'name': 'Non Interventional', 'type': 'OTHER', 'armGroupLabels': ['1', '2', '3', '4', '5', '6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Chu Nancy', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'Laurent Peyrin-Biroulet, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of IBD Unit Inserm U954 Nancy University Hospital FRANCE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}