Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-03-02 @ 3:50 AM
Study NCT ID:
NCT06449820
Status:
COMPLETED
Last Update Posted:
2025-05-06
First Post:
2024-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Janus Kinase Inhibitors for the Treatment of Acute Severe Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2024-04-15', 'studyFirstSubmitQcDate': '2024-06-07', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment failure up to day 98 after JAKi initiation to describe treatment effectiveness', 'timeFrame': 'after study completion, average of 1 month', 'description': '* Absence of steroid-free clinical remission according to the PRO-2 (stool ≤1 and rectal bleeding sub-score of 0)\n* Use of a prohibited treatment for relapse (partial Mayo score \\>5)\n* Severe adverse event leading to discontinuation of JAKi treatment\n* Colectomy\n* Death during the study period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis', 'Inflammatory Bowel Diseases']}, 'descriptionModule': {'briefSummary': 'Ulcerative colitis (UC) is an incurable, immune-mediated inflammatory disease of the large bowel that typically requires long term immunosuppressive drugs to induce and maintain remission. Hospitalisation due to severe, uncontrolled disease is a common occurrence and estimated to affect up to 25% of UC patients. Janus kinase inhibitors (JAKi) have attracted considerable attention as potential candidates for treating hospitalised patients with severe UC and are increasingly used in this setting. For tofacitinib, there are accumulating data supporting their use as effective induction agents to prevent colectomy and reduce length of hospitalisation, however, these are limited to small case series and small cohort studies only. There are no published data for the use of filgotinib and upadacitinib for treating severe inpatient colitis.\n\nThe aim of this study is to develop a large retrospective cohort of JAKi-treated hospitalised UC patients to describe the safety and effectiveness of using JAKi in this setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized for ulcerative colitis disease relapse and treated during their stay with JAKi (tofacitinib, filgotinib, or upadacitinib) between 01/01/2019 and 01/12/2023.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient ≥ 18 years old,\n* Established diagnosis of ulcerative colitis as per ECCO (European Crohn´s and Colitis Organisation) criteria,\n* Hospitalisation at any point for treatment of ulcerative colitis disease relapse,\n* Receiving at least one dose of tofacitinib, filgotinib, or upadacitinib for the treatment of severe UC during inpatient stay,\n* Endoscopically confirmed active disease (Mayo endoscopic subscore ≥ 2) within previous four weeks,\n* Patient who has received full information about the organization of the research and who has not objected to his or her participation and to the use of his or her data.\n\nExclusion Criteria:\n\n* Diagnosis of Crohn's disease or unclassified Inflammatory Bowel Disease,\n* Receiving JAKi prior to admission,\n* Clostridium difficile, cytomegalovirus (CMV), or other enteric infections identified on admission."}, 'identificationModule': {'nctId': 'NCT06449820', 'acronym': 'ATTRACT', 'briefTitle': 'Janus Kinase Inhibitors for the Treatment of Acute Severe Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Janus Kinase Inhibitors for the Treatment of Acute Severe Ulcerative Colitis: a Retrospective Cohort Study', 'orgStudyIdInfo': {'id': '2024PI030'}}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'state': 'Sélectionnez Un Département / État', 'country': 'France', 'facility': 'Nancy University Hospital', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator / Scientific responsible', 'investigatorFullName': 'Dr Laurent PEYRIN-BIROULET', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}