A Trial on the Remission Rates of Type I Autoimmune Pancreatits With High-risk of Recurrence (AIP；MMF)

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.

• 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 rate within 1 years in high-risk type I AIP patients receiving glucocorticoid monotherapy versus glucocorticoid combined with MMF maintenance therapy

1. Primary completion expected

   30 Sept 2029

2. Last registry update

   6 Oct 2026

3. Started

   30 Jun 2024

4. Registered

   21 Jun 2024