Ignite Creation Date:
2024-07-17 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468709
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-05-23
Brief Title:
A Trial on the Recurrence Free Survival Rate of Type I AIP With High-risk of Recurrence
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
A Prospective Randomized Controlled Trial on the Recurrence Free Survival Rate of Type I AIP With High-risk of Recurrence Patients Receiving Glucocorticoid Maintenance TherapyGlucocorticoid Combined With MMF Maintenance Therapy
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 IgG44 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 organsMultiple 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 AIPMain 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None