[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636347":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":20,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":33,"acronym":20,"eligibilityCriteria":34,"healthyVolunteers":31,"sex":35,"minAge":36,"maxAge":37,"enrollmentInfo":38,"targetDuration":20,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":20,"overallStatus":47,"whyStopped":20,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":20},{"fullName":5,"class":6},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Adalimumab Solution for Injection 20mg\u002F40mg","EXPERIMENTAL","For children with a body weight of ≥ 40 kg, the recommended loading dose is 160 mg. Then, 80 mg is given 2 weeks later, and subsequently, 40 mg is administered every 2 weeks for maintenance treatment.\n\nFor children with a body weight of 17 - 40 kg, the loading dose is 80 mg. 40 mg is given 2 weeks later, and then 20 mg is administered every 2 weeks for maintenance treatment.\n\nIf necessary, the dosing frequency can be increased to once a week according to the results of therapeutic drug monitoring and\u002For clinical response.",[13],"Drug: Adalimumab Solution for Injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Adalimumab Solution for Injection","Adalimumab is a fully human anti-tumour necrosis factor-alpha monoclonal antibody that inhibits the downstream inflammatory cascade by blocking Tumor Necrosis Factor-α (TNF-α), a core inflammatory factor in psoriasis.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Lanlan Geng, Doctor","CONTACT","18902268612","13622237569@163.com",{"type":28,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100636347","phase-4-post---marketing-case-registration-study-on-the-safety-and-efficacy-of-adalimumab-solution-for-injection-in-chinese-pediatric-patients-with-moderate---to---severe-active-crohns-disease-100636347",false,"NCT07564505","Post - Marketing Case Registration Study on the Safety and Efficacy of Adalimumab Solution for Injection in Chinese Pediatric Patients With Moderate - to - Severe Active Crohn's Disease","Inclusion Criteria:\n\n* Age is between 6 years old (inclusive) and 17 years old (inclusive), regardless of gender.\n* Diagnosed as having moderate - to - severe active pediatric Crohn's disease according to the \"Expert Consensus on the Diagnosis and Treatment of Pediatric Inflammatory Bowel Disease 2019\".\n* (3) Pediatric Crohn's disease patients who have been prescribed Adalimumab Solution for Injection by doctors after a full assessment of risks\u002Fbenefits.Both the patient and their guardian must sign the informed consent form. The research protocol\u002Finformed consent form used for data collection and data verification should comply with local laws and regulatory requirements.\n\nExclusion Criteria:\n\n* (1) According to the instruction manual of Adalimumab Solution for Injection and the judgment of the treating physician, the patient is not suitable for treatment with Adalimumab Solution for Injection.\n* (2) Pediatric Crohn's disease patients who have received any live vaccines within 3 months prior to the first dose of Adalimumab Solution for Injection or who plan to receive any live vaccines during the study period.\n* Patients who are participating in other clinical studies. (4) Patients whom the investigator deems unsuitable for participation in this trial.","ALL","6 Years","17 Years",{"count":39,"type":40},30,"ESTIMATED","INTERVENTIONAL",[43],"PHASE4","This study is a real - world clinical research of adalimumab. The project plans to enroll 30 subjects, aiming to evaluate the incidence of serious adverse events (SAEs) within 12, 26, and 52 weeks after treatment; as well as the incidence of adverse events (AEs), adverse drug reactions (ADRs), adverse events of special interest (AESIs), and serious ADRs at 12, 26, and 52 weeks after treatment.",[46],"Children Aged 6 Years and Above With Moderate - to - Severe Active Crohn's Disease","NOT_YET_RECRUITING","2026-04-29",{"date":50,"type":51},"2026-05-04","ACTUAL",{"date":53,"type":40},"2026-05",{"date":55,"type":40},"2029-03",{"name":5,"class":6}]