A Trial on the Remission Rates of Type I Autoimmune Pancreatits With High-risk of Recurrence
ConditionType 1 AIP
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent form with date;
Promise to comply with research procedures and cooperate with the implementation of the entire process research;
Age 18 and above, regardless of gender;
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;
Disqualifiers
Pregnant/lactating women; Inability or refusal to sign informed consent form;
History of mental illness;
Allergy to research interventions;
With malignant tumors;
Trial design
Design model
Parallel
Treatments tested in this trial
Glucocorticoids
DrugThe 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
Glucocorticoids+MMF
DrugThe 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
Treatment groups
86 Participants
are divided into 2 treatment groupsGroup A: Glucocorticoids groupActive comparator 1 intervention
Group B: Glucocorticoids+MMF groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
3 years2
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.
Time frame
1 yearSecondary outcomes
1
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.
Time frame
3 years2
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.
Time frame
3 years3
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.
Time frame
3 years4
Adverse reactions
Adverse reactions including the allergic reactions to drugs
Time frame
3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ruijin Hospital
Lead sponsor
First Hospital of China Medical University
Collaborator
Tianjin Medical University General Hospital
Collaborator
Zunyi Medical College
Collaborator
The First People's Hospital of Yunnan
Collaborator
Anhui Provincial Hospital
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
Zhongshan Hospital Affiliated to Xiamen University
Collaborator
Second Affiliated Hospital of Soochow University
Collaborator
Shengjing Hospital
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Collaborator
The Third Affiliated Hospital of Soochow University
Collaborator
First Affiliated Hospital of Zhejiang University
Collaborator
Source ClinicalTrials.gov