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RECRUITING
NCT06468709
PHASE4

A Trial on the Recurrence Free Survival Rate of Type I AIP With High-risk of Recurrence

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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.

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 Therapy/Glucocorticoid Combined With MMF Maintenance Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

86

Start Date

2024-06-20

Completion Date

2027-07-31

Last Updated

2024-06-21

Healthy Volunteers

No

Conditions

Interventions

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

DRUG

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

Locations (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, China