Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:24 PM
Study NCT ID:
NCT05705856
Status:
UNKNOWN
Last Update Posted:
2023-06-13
First Post:
2023-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety of Ustekinumab Intensification in Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069549', 'term': 'Ustekinumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-12', 'studyFirstSubmitDate': '2023-01-15', 'studyFirstSubmitQcDate': '2023-01-29', 'lastUpdatePostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants with steroid-free clinical remission at Week 24', 'timeFrame': 'Week24', 'description': 'Percentage of participants with steroid-free clinical remission at Week 24 from the escalation will be assessed. Steroid-free clinical remission (performed only in patients on prednisone or budesonide at time of initiation of UST) was defined as tapering off steroids completely and HBI ≤ 4 points or complete resolution in CD symptoms or severity assessed by PGA.'}], 'secondaryOutcomes': [{'measure': 'Percentage of participants with biochemical remission at Week 24', 'timeFrame': 'Week 24', 'description': 'Percentage of participants with biochemical remission at Week 24 from the escalation will be assessed. Biochemical remission was defined as a CRP concentration ≤5 mg/L and a FCP level of ≤200 µg/g.'}, {'measure': 'Percentage of participants with endoscopic remission at Week 52', 'timeFrame': 'Week 52', 'description': 'Percentage of participants with endoscopic remission at Week 52. Endoscopic remission was defined as SES-CD ≤3 or absence of ulcers or described as the absence of ulceration.'}, {'measure': 'Percentage of participants with normal fecal calprotectin level at Week 52', 'timeFrame': 'Week 52', 'description': 'Percentage of participants with normal fecal calprotectin level at 52w (among patients with baseline fecal calprotectin greater than 200ug/g)'}, {'measure': 'Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'up to 1.5 years', 'description': 'The percentage of participants with at least one adverse event and subcategories of adverse events will be assessed. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.'}, {'measure': 'Percentage of Participants with Infections and Serious Infections', 'timeFrame': 'up to 1.5 years', 'description': 'Percentage of participants with infections and serious infections will be reported.'}, {'measure': 'Percentage of Participants continue UST', 'timeFrame': 'up to 1.5 years', 'description': 'Proportion of patients who continue UST during the follow-up will be assessed.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ustekinumab', 'dose escalation', "Crohn's disease"], 'conditions': ['Crohn Disease']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the efficacy and safety of intravenous administration at regular intervals of Ustekinumab in participants with loss of response to standard regimen or have evidence of high activity clinically, biochemically or endoscopically.', 'detailedDescription': 'This study evaluates the efficacy and safety of intravenous administration at regular intervals of Ustekinumab. It consists of escalation treatment period (Week 0 to 52); and safety follow up visit (24 weeks after last dose). Study assessments will include Harvey-Bradshaw index (HBI), Physician Global Assessment Score (PGA), laboratory evaluations, endoscopic evaluation, review of concomitant medications and adverse events (AEs).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing Ustekinumab dose intensification with at least two or more intravenous infusions at the discretion of the treating physician instead of a scheduled SC dose at the discretion of the treating physician.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Agree to participate in the study\n* With active Crohn's disease\n* Undergoing Ustekinumab dose intensification with at least two or more intravenous infusions at the discretion of the treating physician\n* HBI ≥ 5 before Ustekinumab therapy\n* Over 18 years of age\n\nExclusion Criteria:\n\n* Who had received Ustekinumab for an indication\n* Pregnant or nursing\n* L4 type\n* History of enterectomy or enterostomy related to disease\n* Who used total enteral nutrition for more than 2 weeks due to complications such as obstruction, abscess and perforation after starting Ustekinumab therapy\n* Pregnant and lactating women"}, 'identificationModule': {'nctId': 'NCT05705856', 'briefTitle': "Effectiveness and Safety of Ustekinumab Intensification in Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': "Effectiveness and Safety of Ustekinumab Intensification in Crohn's Disease: a Retrospective Observational Study", 'orgStudyIdInfo': {'id': '2023-0004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'intravenous maintenance at early stage', 'description': 'Participants who have evidence of high activity clinically, biochemically or endoscopically : HBI ≥8, inflammatory markers significantly increased (CRP \\> 5mg/L, fecal calprotectin\\> 200mg/g), SES-CD≥ 7, will get multiple intravenous injections of Ustekinumab maintenance after induction.', 'interventionNames': ['Drug: Ustekinumab']}, {'label': 'intravenous escalation when poor response', 'description': 'Participants who experience a loss of response or poor response to 90 mg Ustekinumab standard therapy will receive Ustekinumab intravenously at regular interval or at shorten interval.', 'interventionNames': ['Drug: Ustekinumab']}], 'interventions': [{'name': 'Ustekinumab', 'type': 'DRUG', 'otherNames': ['UST', 'Ustekinumab antibody'], 'description': 'Patients will receive an intravenous induction (adjusted 6 mg/kg dose) followed by subcutaneous 90 mg every 12 or 8 weeks, and will receive dose escalation when response is not effective enough.', 'armGroupLabels': ['intravenous escalation when poor response', 'intravenous maintenance at early stage']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuting Wang, doctor', 'role': 'CONTACT', 'email': 'wangyuting22@126.com', 'phone': '18868102022'}], 'facility': '2nd Affiliated Hospital, School of Medicine, Zhejiang University, China', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Yuting Wang, MD', 'role': 'CONTACT', 'email': 'wangyuting22@126.com', 'phone': '18868102022'}], 'overallOfficials': [{'name': 'Yan Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '2nd Affiliated Hospital, School of Medicine, Zhejiang University, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}