Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2026-01-01 @ 4:03 AM
Study NCT ID:
NCT05205603
Status:
UNKNOWN
Last Update Posted:
2023-12-05
First Post:
2022-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe 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': 'C543529', 'term': 'vedolizumab'}, {'id': 'D019804', 'term': 'Mesalamine'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 438}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-03', 'studyFirstSubmitDate': '2022-01-05', 'studyFirstSubmitQcDate': '2022-01-11', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'endoscopic remission rate at 12 months', 'timeFrame': '12 months after first intervention administration', 'description': 'endoscopic remission rate at 12 months'}], 'secondaryOutcomes': [{'measure': 'normalization rate of serum biomarker at 12 months', 'timeFrame': '12 months after first intervention administration', 'description': 'normalization rate of serum biomarker at 12 months'}, {'measure': 'normalization rate of serum biomarker at 6 months', 'timeFrame': '6 months after first intervention administration', 'description': 'normalization rate of serum biomarker at 6 months'}, {'measure': 'clinical remission rate at 12 months', 'timeFrame': '12 months after first intervention administration', 'description': 'clinical remission rate at 12 months'}, {'measure': 'clinical remission rate at 6 months', 'timeFrame': '6 months after first intervention administration', 'description': 'clinical remission rate at 6 months'}, {'measure': 'clinical response rate at 12 months', 'timeFrame': '12 months after first intervention administration', 'description': 'clinical response rate at 12 months'}, {'measure': 'clinical response rate at 6 months', 'timeFrame': '6 months after first intervention administration', 'description': 'clinical response rate at 6 months'}, {'measure': 'endoscopic remission rate at 6 months', 'timeFrame': '6 months after first intervention administration', 'description': 'endoscopic remission rate at 6 months'}, {'measure': 'endoscopic response rate at 12 months', 'timeFrame': '12 months after first intervention administration', 'description': 'endoscopic response rate at 12 months'}, {'measure': 'endoscopic response rate at 6 months', 'timeFrame': '6 months after first intervention administration', 'description': 'endoscopic response rate at 6 months'}, {'measure': 'life quality changes at 12 months', 'timeFrame': '12 months after first intervention administration', 'description': 'life quality evaluated by IBDQ (inflammatory bowel disease questionnaire) at 12 months'}, {'measure': 'life quality changes at 6 months', 'timeFrame': '6 months after first intervention administration', 'description': 'life quality evaluated by IBDQ (inflammatory bowel disease questionnaire) at 6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ulcerative colitis', 'biologics', 'mesalazine'], 'conditions': ['Ulcerative Colitis', 'Efficacy, Self', 'Biologics', 'Mesalazine']}, 'descriptionModule': {'briefSummary': 'Endocopic remission rates of moderate to severe ulcerative colitis are low. Biologics including Vedolizumab, infliximab, and adalimumab are effective in induction and maintainence of ulcerative colitis. The role of 5-ASA in promoting a higher rate of endocsopic remission is unclear. We aim to evaluate the efficacy of combination of 5-ASA and biologics in treating ulcerative colitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with moderate and severe ulcerative colitis;\n2. Subjects were above 18 years old and below 80 years;\n3. Indications of 5-ASA or biological treatment;\n4. According to the clinical symptoms, ulcerative colitis was diagnosed by endoscopic changes, pathological manifestations. The disease activity of UC was assessed according to the modified Mayo scoring system (modified Mayo: 6\\~12 for patients with moderate to severe ulcerative colitis);\n5. If the subject is a woman, a pregnancy test at baseline is needed to exclude pregnancy. Female patients must follow the contraceptive recommendations of the project;\n6. Subjects must be able and willing to provide written informed consent and comply with the requirements of this study protocol.\n\nExclusion Criteria:\n\n1. No indications of 5-ASA or biological treatment;\n2. ulcerative colitis patients who had previously undergone a partial colectomy;\n3. Patients who are unable to use 5-ASA for a long time;\n4. Patients with severe, progressive, or uncontrolled kidney, liver, blood, or endocrine diseases or symptoms;\n5. Presence of infected persons, Patients with a contraindication to the use of biological agents such as C. difficile infection or other intestinal pathogens, active tuberculosis or intestinal tuberculosis infection, human immunodeficiency virus (HIV) infection, active hepatitis B or hepatitis C (defined as: ① HBV: hepatitis B surface antigen (HBs Ag) positive (+), Or patients with positive for hepatitis B core antibody (HBcAb) and the qualitative test results of HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) meet the detection criteria; ② HCV: Any patient with an anti-HCV antibody (HCV Ab) -positive patient with a detectable HCV ribonucleic acid (RNA);\n6. Patients with a history of gastrointestinal dysplasia, or dysplasia on any biopsy performed on endoscopy, excluding low-grade dysplasia lesions; known history of lymphoproliferative disease (including lymphoma), or signs and symptoms (e. g., lymphadenopathy and / or splenomegaly); patients with current or previous malignancy;\n7. Has been involved in other clinical studies.'}, 'identificationModule': {'nctId': 'NCT05205603', 'briefTitle': 'Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': 'Sixth Affiliated Hospital, Sun Yat-sen University'}, 'officialTitle': 'Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis: a Multicenter, Prospective, Randomized, Controlled Clinical Study', 'orgStudyIdInfo': {'id': '2021ZSLYEC-456'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Biologics group', 'description': 'Biologics including infliximab and vedolizumab. infliximab: 5mg/kg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 5mg/kg every 8 weeks.\n\nvedolizumab: 300mg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 300mg every 8 weeks.', 'interventionNames': ['Drug: Infliximab', 'Drug: Vedolizumab']}, {'type': 'EXPERIMENTAL', 'label': '5-ASA group', 'description': '5-ASA combined with biologics (including infliximab and vedolizumab). infliximab: 5mg/kg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 5mg/kg every 8 weeks.\n\nvedolizumab: 300mg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 300mg every 8 weeks.\n\nmesalazine: at a dose of 4-6g/d systemic or topical therapy', 'interventionNames': ['Drug: Infliximab', 'Drug: Vedolizumab', 'Drug: Mesalazine']}], 'interventions': [{'name': 'Infliximab', 'type': 'DRUG', 'description': 'Infliximab, 5mg/kg at week 0,2,6 and schedule administration at every 8 weeks', 'armGroupLabels': ['5-ASA group', 'Biologics group']}, {'name': 'Vedolizumab', 'type': 'DRUG', 'description': 'Vedolizumab, 300mg at week 0,2,6 and schedule administration at every 8 weeks', 'armGroupLabels': ['5-ASA group', 'Biologics group']}, {'name': 'Mesalazine', 'type': 'DRUG', 'description': 'Mesalazine, 4-6g/d, systemic and/or topical administration', 'armGroupLabels': ['5-ASA group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Guo', 'role': 'CONTACT', 'phone': '13508389768'}], 'facility': "People's Hospital of Chongqing", 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '501655', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiayin Yao', 'role': 'CONTACT', 'email': 'yaojy3@mail.sysu.edu.cn', 'phone': '13826462890'}], 'facility': 'the Sixth Affiliated Hospital of Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Peizhu Su', 'role': 'CONTACT', 'phone': '18038866391'}], 'facility': "First People's Hospital of Foshan", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Wan', 'role': 'CONTACT', 'phone': '13826468006'}], 'facility': 'Guangzhou Panyu Central Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huangwei Chen', 'role': 'CONTACT', 'phone': '13928259021'}], 'facility': 'Nanhai Hospital, Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guohua Li', 'role': 'CONTACT', 'phone': '13825522688'}], 'facility': 'Shunde Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Shantou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jin Yu', 'role': 'CONTACT', 'phone': '13924781267'}], 'facility': 'First Affiliated Hospital of Shantou University Medical College', 'geoPoint': {'lat': 23.35489, 'lon': 116.67876}}, {'city': 'Dalian', 'state': 'Liaoning', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoying Feng', 'role': 'CONTACT', 'phone': '17709870699'}], 'facility': 'The Second Affiliated Hospital of Dalian Medical University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Feng Tian', 'role': 'CONTACT', 'phone': '18940251088'}], 'facility': 'Shengjing Hospital', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaocang Cao', 'role': 'CONTACT', 'phone': '13302042403'}], 'facility': 'General Hospital of Tianjin Medical University', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Hanzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Chen', 'role': 'CONTACT', 'phone': '13757118653'}], 'facility': 'Zhejiang University'}], 'centralContacts': [{'name': 'Min Zhi', 'role': 'CONTACT', 'email': 'zhimin@mail.sysu.edu.cn', 'phone': '13825086505'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sixth Affiliated Hospital, Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}