Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-31 @ 10:27 PM
Study NCT ID:
NCT04999228
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2021-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Top Down Versus Step up in Pediatric Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069285', 'term': 'Infliximab'}, {'id': 'D019804', 'term': 'Mesalamine'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'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'}, {'id': 'D062368', 'term': 'meta-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000636', 'term': 'Aminosalicylic Acids'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2021-08-05', 'studyFirstSubmitQcDate': '2021-08-05', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mucosal healing rate', 'timeFrame': '12 week after intervention', 'description': 'The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) ≦1 points is defined as mucosal healing. This will be evaluated by inflammatory bowel disease endoscopist.'}], 'secondaryOutcomes': [{'measure': 'The relapse rates', 'timeFrame': '1 year after intervention', 'description': 'Relapse is defined as an increased in pediatric Ulcerative Colitis activity index (PUCAI) score by 10 points or more after clinical remission or when new Ulcerative Colitis treatment needed to be started due to worsening of symptoms. This will be evaluated by gastroenterologist.'}, {'measure': 'Sustained durations of remission', 'timeFrame': '1 year after intervention', 'description': 'Sustained pediatric Ulcerative Colitis activity index (PUCAI) score \\<10 points during follow-up（week 10 to week 54 after intervention). This will be evaluated by gastroenterologist.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis', 'Infliximab', 'Children']}, 'descriptionModule': {'briefSummary': 'Pediatric Ulcerative Colitis (UC) patients with moderate to severe disease activity at high risk of colectomy. Early use of biologic agents will likely be more effective. But there were no studies identified that compared a strategy of upfront biologic-based therapy versus gradual step-up therapy. In our study, newly diagnosed moderate to severe pediatric UC patients (6-18 years old) will be randomly divided into infliximab (IFX) treatment group (Top down group, TD) and corticosteroids (CS) treatment group (Step-up group, SU). Mucosal healing rate at week 12 will be compared between the two groups. The relapse rates and sustained durations of remission within one year will also be evaluated.', 'detailedDescription': 'Pediatric ulcerative colitis (UC) is typically more extensive and has a more active disease course than adult UC. Pediatric UC patients with moderate to severe disease activity at high risk of colectomy. Rapid disease control may improve the prognosis of the disease and reduce the rate of surgery. Early use of biologic agents will likely be more effective. But there were no studies identified that compared a strategy of upfront biologic-based therapy versus gradual step-up therapy. In our study, newly diagnosed moderate to severe pediatric UC patients (6-18 years old) will be randomly divided into infliximab (IFX) treatment group (Top down group, TD) and corticosteroids (CS) treatment group (Step-up group, SU). A decrease of pediatric ulcerative colitis activity index (PUCAI) at least 20 points were defined as Clinical response. Clinical response will be evaluated at week 2 in SU group and week 6 in TD group. For no-responder, treatment plan will be changed. Clinical remission rate at week 10 and mucosal healing rate at week 12 will be compared between the two groups. The relapse rates and sustained durations of remission within one year will also be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. newly diagnosed UC;\n2. moderate to severe disease activity\n3. Age: 6 to 18 years old\n\nExclusion Criteria:\n\n1. with mild disease activity\n2. Have been treated with Corticosteroid or biological agents for UC'}, 'identificationModule': {'nctId': 'NCT04999228', 'briefTitle': 'Top Down Versus Step up in Pediatric Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'First-line Treatment With Infliximab Versus Corticosteroids in Children With Newly Diagnosed Moderate to Severe Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'UC1.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Infliximab treatment group', 'description': 'For newly diagnosed moderate to severe Pediatric ulcerative colitis, infliximab will be used as first-line treatment', 'interventionNames': ['Drug: Infliximab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Corticosteroid treatment group', 'description': 'For newly diagnosed moderate to severe Pediatric ulcerative colitis, corticosteroids will be used as first-line treatment', 'interventionNames': ['Drug: Corticosteroids']}], 'interventions': [{'name': 'Infliximab', 'type': 'DRUG', 'otherNames': ['5-ASA, AZA'], 'description': 'Infliximab will be administered intravenously at a dose of 5 mg/kg for 0, 2, and 6 weeks, then every 8 weeks for 1 year.', 'armGroupLabels': ['Infliximab treatment group']}, {'name': 'Corticosteroids', 'type': 'DRUG', 'otherNames': ['5-ASA, AZA'], 'description': 'Corticosteroid will be given at a dose of 1-2mg/kg/day (maximum 60 mg/kg/day),oral or intravenously for 12 to 14 weeks.', 'armGroupLabels': ['Corticosteroid treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201102', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Cui Zheng', 'role': 'CONTACT', 'email': 'zhengcuifang2@126.com'}], 'facility': "Children's Hospital of Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Cui fang Zheng', 'role': 'CONTACT', 'email': 'zhengcuifang2@126.com', 'phone': '8615221881022'}], 'overallOfficials': [{'name': 'Ying Huang', 'role': 'STUDY_DIRECTOR', 'affiliation': "Children's Hospital of Fudan University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Gastroenterology', 'investigatorFullName': 'Ying HUANG', 'investigatorAffiliation': "Children's Hospital of Fudan University"}}}}