[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552101":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":40,"studyPopulation":33,"armGroups":41,"interventions":54,"overallOfficials":68,"centralContacts":72,"locations":78,"responsibleParty":95,"collaborators":98,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":129,"sex":135,"minAge":136,"maxAge":33,"enrollmentInfo":137,"targetDuration":33,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":80,"whyStopped":33,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":33},[9,13],{"measure":10,"description":11,"timeFrame":12},"Disease remission rate within 3 years in high-risk type I AIP patients receiving glucocorticoid monotherapy versus glucocorticoid combined with MMF maintenance therapy","Disease remission is defined as the proportion of patients achieving complete or partial resolution of clinical symptoms, normalization or significant improvement of imaging findings, and reduction of serum IgG4 levels. Remission rate will be compared between the glucocorticoid monotherapy group and the glucocorticoid plus MMF combination therapy group within 3 years of follow-up.","3 years",{"measure":14,"description":15,"timeFrame":16},"Disease remission rate within 1 years in high-risk type I AIP patients receiving glucocorticoid monotherapy versus glucocorticoid combined with MMF maintenance therapy","Disease remission is defined as the proportion of patients achieving complete or partial resolution of clinical symptoms, normalization or significant improvement of imaging findings, and reduction of serum IgG4 levels. Remission rate will be compared between the glucocorticoid monotherapy group and the glucocorticoid plus MMF combination therapy group within 1 years of follow-up.","1 year",[18,21,24,27,30],{"measure":19,"description":20,"timeFrame":12},"Changes in endocrine function","Endocrine function will be assessed by the following measures: (1) incidence of new-onset diabetes mellitus during the 3-year follow-up period; (2) change from baseline in HbA1c levels; (3) change from baseline in C-peptide levels; (4) change from baseline in insulin secretion capacity.",{"measure":22,"description":23,"timeFrame":12},"Changes in external secretion pancreatic function","Pancreatic exocrine function will be assessed by the following measures: (1) incidence of pancreatic exocrine insufficiency during the 3-year follow-up period; (2) change from baseline in serum vitamin levels (including vitamin A, D, E); (3) change from baseline in serum 25-OH-D3 levels.",{"measure":25,"description":26,"timeFrame":12},"Incidence of malignant tumors","Incidence of newly diagnosed malignant tumors, specifically gastrointestinal tumors (including esophageal, gastric, pancreatic, and colorectal tumors), detected by endoscopic examination during the 3-year follow-up period. All tumor diagnoses will be confirmed by histopathological evaluation.",{"measure":28,"description":29,"timeFrame":12},"Adverse reactions","Adverse reactions including the allergic reactions to drugs",{"measure":31,"description":32,"timeFrame":12},"Treatment costs","to assess the total treatment costs in 3 years",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":39,"maskingDescription":33,"whoMasked":33},"NONE","Autoimmune pancreatitis (AIP) is an autoimmune disease with low incidence rate and involving the pancreas. It can be divided into type I AIP and type II AIP. In China, type I AIP is predominant, accompanied by elevated IgG4 levels, diffuse or segmental pancreatic enlargement, and irregular narrowing of the pancreatic duct. Glucocorticoids (GC) have a significant therapeutic effect. Even though a consensus has been reached on the effective initial GC treatment dose, type I AIP is prone to recurrence after GC induction and maintenance therapy. Currently, there is no consensus on how to reduce the disease recurrence rate in high-risk type I AIP patients. The International Pancreatic Society has released an international consensus on AIP, indicating that the risk factors for AIP recurrence are still unclear. The following are possible signs of recurrence: IgG4\\>4 times the upper limit of normal value before treatment; The serum IgG4 level remained high after GC treatment; Pancreatic diffuse enlargement; IgG4-SC with proximal bile duct involvement; Involvement of extrapancreatic organs.Multiple studies have shown that immunosuppressants (IM) combined with GC can effectively reduce the disease recurrence rate in IgG4 RD patients, including azathioprine, mycophenolate mofetil (MMF), etc. Among them, the incidence of adverse reactions in MMF is relatively low. As a special type of IgG4-RD, there is currently no prospective study evaluating the efficacy and safety of GC combined with MMF treatment in high-risk recurrent type I AIP patients. The smooth implementation of this project can provide new treatment ideas and evidence-based medicine for reducing the recurrence rate of high-risk type I AIP.Main research objective: To evaluate the impact of corticosteroid monotherapy and corticosteroid combined with MMF maintenance therapy on disease remission rate in high-risk type I AIP patients with recurrence within 3 years Secondary research objective: (I) To evaluate the impact on endocrine function; (II) Evaluate the impact on external secretion function; (III) Evaluate the impact on the incidence of malignant tumors; (IV) Adverse reactions; (V) Treatment costs.\n\nParticipants will be followed for a total of 36 months. An initial analysis of 12-month follow-up data is planned, with findings intended for dissemination through scientific presentations and\u002For publication as preliminary results. Follow-up will continue through Month 36, after which the final analysis and dissemination of results are planned.\n\nPeripheral blood samples will be collected during the study for exploratory mechanistic analyses of immune-cell populations and circulating biomarkers. These analyses will characterize biological changes during treatment and explore their associations with disease remission, relapse, and treatment response.",[42,48],{"label":43,"type":44,"description":45,"interventionNames":46},"Glucocorticoids group","ACTIVE_COMPARATOR","Induction therapy: Prednisone 30mg\u002Fd, lasting for 4 weeks, then decreasing by 5mg\u002Fd every 2 weeks until maintained at 5mg\u002Fd.\n\nPeripheral blood samples will also be collected for exploratory mechanistic analyses.",[47],"Drug: Glucocorticoids",{"label":49,"type":50,"description":51,"interventionNames":52},"Glucocorticoids+MMF group","EXPERIMENTAL","GC: Induction therapy: 30mg\u002Fd, lasting for 4 weeks, then decreasing by 5mg\u002Fd every 2 weeks until maintained at 5mg\u002Fd. At the initial stage of simultaneous treatment, 1.0g-1.5g MMF combined with GC treatment.\n\nPeripheral blood samples will also be collected for exploratory mechanistic analyses.",[53],"Drug: Glucocorticoids+MMF",[55,62],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"DRUG","Glucocorticoids","The study subjects were randomly divided into a GC monotherapy maintenance group and a GC combined with MMF maintenance group in a 1:1 ratio. The randomization sequence was generated online using a computer randomization scheme. Group A was the GC monotherapy maintenance group",[43],[61],"Prednisone",{"type":56,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"Glucocorticoids+MMF","The study subjects were randomly divided into a GC monotherapy maintenance group and a GC combined with MMF maintenance group in a 1:1 ratio. The randomization sequence was generated online using a computer randomization scheme. Group B was the GC+MMF maintenance group",[49],[67],"Prednisone and MMF",[69],{"name":70,"affiliation":5,"role":71},"Duowu Zou, Doctor","PRINCIPAL_INVESTIGATOR",[73],{"name":74,"role":75,"phone":76,"phoneExt":33,"email":77},"XIaonan Shen, Doctor","CONTACT","18817554263","hgssldsxn@163.com",[79],{"facility":5,"status":80,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"RECRUITING","Shanghai","Shanghai Municipality","200025","China","CN",{"type":87,"coordinates":88},"Point",[89,90],121.45806,31.22222,{"lat":90,"lon":89},[93],{"name":94,"role":75,"phone":76,"phoneExt":33,"email":77},"Shen, Doctor",{"type":71,"investigatorFullName":96,"investigatorTitle":97,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"ZOU DUOWU","Director of Gastroenterology Department",[99,101,103,105,107,110,112,115,117,119,121,123,125],{"name":100,"class":6},"First Hospital of China Medical University",{"name":102,"class":6},"Tianjin Medical University General Hospital",{"name":104,"class":6},"Zunyi Medical College",{"name":106,"class":6},"The First People's Hospital of Yunnan",{"name":108,"class":109},"Anhui Provincial Hospital","OTHER_GOV",{"name":111,"class":6},"The First Affiliated Hospital of Nanchang University",{"name":113,"class":114},"Zhongshan Hospital Affiliated to Xiamen University","UNKNOWN",{"name":116,"class":6},"Second Affiliated Hospital of Soochow University",{"name":118,"class":6},"Shengjing Hospital",{"name":120,"class":6},"The Affiliated Hospital of Qingdao University",{"name":122,"class":114},"Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine",{"name":124,"class":6},"The Third Affiliated Hospital of Soochow University",{"name":126,"class":6},"First Affiliated Hospital of Zhejiang University","100552101","phase-4-a-trial-on-the-recurrence-free-survival-rate-of-type-i-aip-with-high-risk-of-recurrence-100552101",false,"NCT06468709","A Trial on the Remission Rates of Type I Autoimmune Pancreatits With High-risk of Recurrence","A Multicenter, Prospective, Randomized Controlled Trial on the Remission Rate of Type I AIP With High-risk of Recurrence Patients Receiving Glucocorticoid Maintenance Therapy\u002FGlucocorticoid Combined With Mycophenolate Mofetil Maintenance Therapy","AIP；MMF","Inclusion Criteria:\n\n1. Signed informed consent form with date;\n2. Promise to comply with research procedures and cooperate with the implementation of the entire process research;\n3. Age 18 and above, regardless of gender;\n4. Confirmed as type I AIP and high-risk for recurrence, including the following characteristics: IgG4\\>4 times the upper limit of normal value before treatment; The serum IgG4 level remained high after GC treatment; Pancreatic diffuse enlargement; IgG4-SC with proximal bile duct involvement; Involvement of extrapancreatic organs;\n5. Indications for treatment, (1) symptomatic individuals may experience pancreatic involvement (such as obstructive jaundice, abdominal pain, lower back pain, etc.) and extrapancreatic organ involvement (such as jaundice caused by bile duct stenosis, etc.); (2) Asymptomatic individuals, who may develop subclinical AIP (persistent pancreatic mass, liver dysfunction with proximal IgG4 associated sclerosing cholangitis) with severe and irreversible damage to important organs;\n6. Able to persist and cooperate with research interventions, such as oral medication;\n7. If it is a woman in the reproductive period, contraception should be used for at least one month before screening, and a commitment should be made to use contraception throughout the entire study period and continue until the specified time after the end of the study\n\nExclusion Criteria:\n\n1. Pregnant\u002Flactating women; Inability or refusal to sign informed consent form;\n2. History of mental illness;\n3. Allergy to research interventions;\n4. With malignant tumors;\n5. Active hepatitis\u002Ftuberculosis and other infectious diseases;\n6. With underlying diseases that are difficult to control, such as severe heart failure, respiratory failure, etc;\n7. Within 3 months, use of glucocorticoids or immunosuppressants due to other illnesses","ALL","18 Years",{"count":138,"type":139},86,"ESTIMATED","INTERVENTIONAL",[142],"PHASE4","Autoimmune pancreatitis (AIP) is an autoimmune disease with low incidence rate and involving the pancreas. In China, type I AIP is predominant. Glucocorticoids (GC) have a significant therapeutic effect. Even though a consensus has been reached on the effective initial GC treatment dose, type I AIP is prone to recurrence after GC induction and maintenance therapy. Currently, there is no consensus on how to reduce the disease recurrence rate in high-risk type I AIP patients. Multiple studies have shown that immunosuppressants (IM) combined with GC can effectively reduce the disease recurrence rate in IgG4 RD patients, including azathioprine, mycophenolate mofetil (MMF), etc. Among them, the incidence of adverse reactions in MMF is relatively low. As a special type of IgG4-RD, there is currently no prospective study evaluating the efficacy and safety of GC combined with MMF treatment in high-risk recurrent type I AIP patients. The smooth implementation of this project can provide new treatment ideas and evidence-based medicine for reducing the recurrence rate of high-risk type I AIP.",[145],"Type 1 AIP",[145,147,57,148],"Recurrence","MMF","2026-10-01",{"date":151,"type":152},"2026-10-06","ACTUAL",{"date":154,"type":152},"2024-06-30",{"date":156,"type":139},"2029-09-30",{"name":5,"class":6},1]