[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"infliximab\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:infliximab":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,68,94,115],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100442629","phase-4-combined-immunosuppression-for-pediatric-crohns-disease-100442629",false,"NCT05043870","Combined Immunosuppression for Pediatric Crohn's Disease","Combination Therapy of Infliximab and Immunosuppressives for Pediatric Crohn's Disease","Inclusion Criteria:\n\n1. 6-18 years old\n2. diagnosis of Crohn's Disease\n3. Pediatric Crohn's disease Activity Index (PCDAI)\\>30 or The Simple Endoscopic Score for Crohn Disease (SES-CD) \\>10 before treatment\n4. receiving exclusive enteral nutrition or corticosteroids as first-line treatment, Pediatric Crohn's disease Activity Index (PCDAI)\\>10 or The Simple Endoscopic Score for Crohn Disease (SES-CD)≥3 after exclusive enteral nutrition or corticosteroids\n5. The patient or legal guardian sign the informed consent documents\n\nExclusion Criteria:\n\n1. history of biological agents targeting at tumor necrosis factor (TNF)\n2. Crohn's Disease-related surgery\n3. infections\n4. tumors","ALL","6 Years","18 Years",{"count":20,"type":21},128,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This is a randomized controlled trial to compare the efficacy and safety of infliximab and immunosuppressives therapy alone or in combination for pediatric Crohn's disease.",[27,28,29,30],"Crohn Disease","Infliximab","Immunosuppression","Children, Only","RECRUITING","2026-03-17",{"date":34,"type":35},"2026-03-19","ACTUAL",{"date":37,"type":35},"2022-10-10",{"date":39,"type":21},"2026-12-31",{"name":41,"class":42},"Children's Hospital of Fudan University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":43},"100592572","investigation-of-the-correlation-between-polyamine-levels-and-their-key-enzymatic-activities-in-association-with-inflammatory-bowel-disease-progression-100592572","NCT06995170","Investigation of the Correlation Between Polyamine Levels and Their Key Enzymatic Activities in Association With Inflammatory Bowel Disease Progression","Inclusion Criteria:\n\n1. Age between 18 and 65 years;\n2. Diagnosed with inflammatory (IBD) according to the Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023, Xi'an) and the Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (2023, Guangzhou);\n3. Complete medical records available and written informed consent obtained from the participant.\n\nExclusion Criteria:\n\n1. Presence of other metabolic disorders;\n2. History of malignant tumors, severe organ dysfunction, or other severe systemic diseases affecting major organs, or hematological disorders;\n3. Diagnosis of influenza, bacterial dysentery, or other infectious diseases within the past 2 weeks;\n4. Presence of other diseases that may interfere with polyamine metabolism;\n5. Use of antibiotics or probiotics within 8 weeks prior to the start of the study.","65 Years",{"count":52,"type":21},146,"OBSERVATIONAL","Inflammatory Bowel Disease (IBD), encompassing Ulcerative Colitis (UC) and Crohn's Disease (CD), significantly impairs patients' quality of life. Current monitoring of disease activity primarily relies on endoscopy combined with histological examination, which is associated with high costs, invasiveness, poor patient tolerance, and risks of complications. Additionally, disease activity indices and laboratory-based IBD staging metrics demonstrate limited utility and accuracy in clinical practice. This study aims to investigate the correlation between polyamine levels and their key enzymes in the polyamine metabolism pathway with IBD activity, thereby establishing a predictive model for IBD progression through polyamine and metabolite measurements; to estimate the efficacy of biologics via polyamine detection, providing a scientific basis for therapeutic selection; and to screen gut microbiota associated with polyamine metabolic alterations, offering evidence-based guidance for probiotic selection in IBD patients.",[56,57,27,58,28],"Inflammatory Bowel Diseases","Colitis, Ulcerative","Polyamines","2025-05-26",{"date":61,"type":35},"2025-05-29",{"date":63,"type":35},"2025-01-01",{"date":65,"type":21},"2025-12",{"name":67,"class":42},"Xijing Hospital",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":43},"100520030","phase-4-tdm-based-infliximab-treatment-for-active-perianal-fistulizing-crohns-disease-100520030","NCT06051253","TDM-based Infliximab Treatment for Active Perianal Fistulizing Crohn's Disease","Efficacy of Infliximab Treatment Based on TDM (Therapeutic Drug Monitoring) in Adult Patients With Active Perianal Fistulizing Crohn's Disease","* Inclusion Criteria:\n\n  1. Age: 19-80 years\n  2. Subjects diagnosed with perianal fistulizing Crohn's disease based on clinical, endoscopic, histological, and radiologic findings, etc.\n  3. Subjects naive to both biological drugs (anti-TNFs, anti-integrin, anti-IL12\u002F23, etc.) and investigational new drugs\n  4. Subjects with at least one draining perianal fistula\n  5. Subjects not responding to two or more conventional treatments (antibiotics, drainage, immunosuppressants, etc.)\n  6. Women with a childbearing potential: Those who agree to follow contraception during study drug administration and for at least 6 months from the last dosing of the study medication\n* Exclusion Criteria:\n\n  1. In cases where written informed consents cannot be provided by the study subjects or the subjects' legally acceptable representative\n  2. Subject with a probability of receiving bowel surgery within 12 weeks after baseline, decided by investigators\n  3. Subjects with temporary or permanent stoma\n  4. Subjects with short bowel syndrome\n  5. Subjects not eligible due to significant bowel strictures or intra-abdominal abscesses\n  6. Subjects who received bowel surgery within 6 months of baseline or subjects who were admitted due to complications associated with bowel strictures or intra-abdominal abscesses within 3 months of baseline\n  7. Subjects with enterovaginal fistula, enterocutaneous fistula, or enteroenteric fistula\n  8. Subjects previously exposed to biologics (anti-TNFs, anti-integrin, anti-IL12\u002F23, etc.) or investigational new drugs\n  9. Subjects with a history of hypersensitivity to monoclonal antibody\n  10. Subjects requiring corticosteroid therapy. However, if oral corticosteroid dose lower or equivalent to prednisolone 20 mg\u002Fday before baseline is given and tapering of oral corticoseroid from baseline is planned, that subjects can be included in the study. Oral corticoseroid is tapered at a schedule of prednisolone 5 mg\u002F7 days (example: if the subject was on oral prednisolone 20 mg\u002Fday before baseline, oral prednisolone is tapered as follows: 15 mg\u002Fday x 7 days -\\> 10 mg\u002Fday x 7 days -\\> 5 mg\u002Fday x 7 days -\\> stopping of prednisolone)\n  11. Subjects with active tuberculosis. However, if the subject has a history of tuberculosis, which was cured with standard anti-tuberculosis therapy according to the standard anti-tuberculosis treatment guidelines, that subject can be included\n  12. Subjects with latent tuberculosis: Subjects determined to be positive for latent tuberculosis by the pulmonology specialist after history taking, physical examination, chest X-ray, and interferon gamma release assay during the screening period. However, even if positive for latent tuberculosis, if 4 week-treatment for latent tuberculosis is completed and if further treatment for latent tuberculosis is planned to be completed, that subject can be included\n  13. Subjects positive for HBsAg. In cases of HBsAg (-), but with IgG Anti-HBc (+), real time quantitative PCR for HBV DNA is required. If HBV DNA is 10 IU\u002FmL or over, that subject should be excluded\n  14. Subjects positive for anti-HCV antibody\n  15. Subjects with a history of infection with HIV or subject positive for HIV Ag\n  16. Subjects positive for Clostridioides difficile toxin assay or Clostridioides difficile culture assay\n  17. Subjects with a heart disease of NYHA Class III\u002FIV\n  18. Subjects with current or previous demyelinating disease\n  19. Subject with a history of malignancy (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and uterine cervix cancer) within 5 years or with a history of dysplasia of colon or small bowel within 5 years.\n  20. Subjects with symptoms or signs of active infection or with a history of treatment for infection within 8 weeks\n  21. Subjects with a history of organ transplantation\n  22. Pregnant or lactating women\n  23. Non-Korean ethnicity according to a family tree\n  24. Subjects decided to be not eligible for the study by investigators","19 Years","80 Years",{"count":78,"type":21},86,[24],"This study will compare the efficacy and safety of TDM (therapeutic drug monitoring)-based infliximab (CT-P13, RemsimaTM) intravenous therapy compared with the standard infliximab (RemsimaTM) intravenous therapy for patients with active perianal fistulzing Crohn's disease.",[27,28,82,83,84],"Perianal Fistula Due to Crohn's Disease","Therapeutic Drug Monitoring","Magnetic Resonance Novel Index for Fistula Imaging in Crohn's Disease Score","2024-05-11",{"date":87,"type":35},"2024-05-14",{"date":89,"type":35},"2023-11-01",{"date":91,"type":21},"2027-06-30",{"name":93,"class":42},"Asan Medical Center",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":114,"locationsCount":43},"100439202","phase-4-top-down-versus-step-up-in-pediatric-ulcerative-colitis-100439202","NCT04999228","Top Down Versus Step up in Pediatric Ulcerative Colitis","First-line Treatment With Infliximab Versus Corticosteroids in Children With Newly Diagnosed Moderate to Severe Ulcerative Colitis","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",{"count":102,"type":21},40,[24],"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.",[106,28,107],"Ulcerative Colitis","Children","2024-02-26",{"date":110,"type":35},"2024-02-28",{"date":112,"type":35},"2021-11-01",{"date":39,"type":21},{"name":41,"class":42},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":4},"100501792","phase-4-hladqa105-genotype-and-the-efficacy-of-treatment-with-infliximab-in-chinese-population-crohns-disease-100501792","NCT05813860","HLADQA1*05 Genotype and the Efficacy of Treatment With Infliximab in Chinese Population Crohn's Disease","Preemptive HLADQA1*05 Genotyping for the Use of Infliximab in Chinese Crohn's Disease：A Multicenter, Prospective, Controlled, Randomized Study","Inclusion Criteria:\n\n* Participants with Crohn's disease who meet the diagnostic criteria of the Consensus Opinion on the Diagnosis and Treatment of Inflammatory Bowel Disease (Beijing, 2018)\n* Meet the indications for IFX use\n* CDAI score of 220-450; age≥18 years, regardless of gender\n* Participants or family members able to understand the study protocol and willing to participate in this study by providing written informed consent\n\nExclusion Criteria:\n\n* NUDT 15 CT and TT genotypes; previous treatment with IFX and\u002For other anti-TNF biologics\n* Participants who are proposed to have given birth and\u002For breastfeeding in the 12 months\n* those with immunosuppressive intolerance or contraindications\n* concurrent chronic diseases or factors of other systems (including severe cardiopulmonary, hepatic and renal, neurological, psychiatric, rheumatic and immune diseases, alcoholism, drug dependence, other chronic active diseases and long-term hormonal or immunosuppressive drugs)\n* Excluding infectious diseases (tuberculosis, etc.)\n* Excluding tumor-related diseases (lymphoma, gastrointestinal tract tumors, etc.)\n* any medical condition\u002Fcombined surgery\u002Fmedication\u002Fother clinically significant abnormal laboratory tests which, in the judgment of the investigator, may affect the results of the test\n* Known refusal or inability to follow protocol requirements for any reason (including planned clinical visits and examinations)",{"count":123,"type":21},976,[24],"Crohn's disease (CD) is a chronic non-specific inflammatory disease of the intestine. Infliximab (IFX) is a kind of one of the anti-tumor necrosis factor agents (anti-TNF) and is the main clinical treatment drug for Crohn's disease, but approximately 30-50% of patients develop a secondary non-response to respond within one year. The main cause of secondary non-response failure is the formation of anti-IFX anti-drug antibodies (ADA). The human leukocyte antigen (HLA) gene is a complex allele that has been associated with susceptibility to a variety of diseases. Studies have shown that HLADQA1\\*05 allele carriage significantly increases the immunogenicity of anti-tumor necrosis factor agents (anti-TNF) and the risk of ADA formation, resulting in a significant reduction in the efficacy of IFX. Our previous retrospective study found an increased risk of ADA, IFX failure to respond and discontinuation in patients with HLADQA1\\*05 variants, and that IFX in combination with immunosuppression improved clinical outcomes in wild-type genotype patients, whereas combination therapy in patients with variant genotype did not optimize clinical outcomes significantly. Therefore, we believe that the impact of HLADQA1\\*05 on the efficacy of IFX in the Chinese population is unclear, and the combination of immunosuppressants in patients with variant HLADQA1\\*05 genotype remains to be validated due to insufficient sample size. We hypothesized that HLADQA1\\*05 wild-type CD patients would have better clinical remission when treated with IFX than HLADQA1\\*05 variant patients and that the combination of immunosuppressants would improve the outcome in wild-type patients but not in variant patients. By advancing this project, we hope to provide high quality evidence on the clinical use of IFX in Crohn's disease in the Chinese population and help physicians to be more selective in the use of IFX alone or in combination with azathioprine, or to switch treatment in a timely manner.",[27,28],"NOT_YET_RECRUITING","2023-05-06",{"date":130,"type":35},"2023-05-09",{"date":132,"type":21},"2023-04-30",{"date":134,"type":21},"2026-10-31",{"name":136,"class":42},"Sixth Affiliated Hospital, Sun Yat-sen University"]