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

June 16, 2024 updated by: ZOU DUOWU, Ruijin Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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: 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

Study Type

Interventional

Enrollment (Estimated)

86

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Signed informed consent form with date;
  2. Promise to comply with research procedures and cooperate with the implementation of the entire process research;
  3. Age 18 and above, regardless of gender;
  4. 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;
  5. 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;
  6. Able to persist and cooperate with research interventions, such as oral medication;
  7. 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

Exclusion Criteria:

  1. Pregnant/lactating women; Inability or refusal to sign informed consent form;
  2. History of mental illness;
  3. Allergy to research interventions;
  4. With malignant tumors;
  5. Active hepatitis/tuberculosis and other infectious diseases;
  6. With underlying diseases that are difficult to control, such as severe heart failure, respiratory failure, etc;
  7. Within 3 months, use of glucocorticoids or immunosuppressants due to other illnesses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Glucocorticoids group
Induction therapy: Prednisone 30mg/d, lasting for 4 weeks, then decreasing by 5mg/d every 2 weeks until maintained at 5mg/d
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
Other Names:
  • Prednisone
Experimental: Glucocorticoids+MMF group
GC: Induction therapy: 30mg/d, lasting for 4 weeks, then decreasing by 5mg/d every 2 weeks until maintained at 5mg/d. At the initial stage of simultaneous treatment, 1.0g-1.5g MMF combined with GC treatment
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
Other Names:
  • Prednisone and MMF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the impact of monotherapy with glucocorticoids and glucocorticoid combined with MMF maintenance therapy on disease remission rate in high-risk type I AIP patients for recurrence within 3 years
Time Frame: 3 years
to evaluate the disease remission rate of monotherapy with glucocorticoids and glucocorticoid combined with MMF maintenance therapy in high-risk type I AIP patients within 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the impact on endocrine function
Time Frame: 3 years
to evaluate the incidence rate of diabetes mellitus, including measuring Hb1Ac, C peptide, insulin secretion.
3 years
Evaluate the impact of external secretion pancreatic function
Time Frame: 3 years
to evaluate the incidence rate of external secretion disfunction of pancreas including the level of vitamin, 25-OH-D3
3 years
Assess the impact on the incidence of malignant tumors
Time Frame: 3 years
to assess the impact on the incidence of gastrointestinal tumors by endoscopies
3 years
Adverse reactions
Time Frame: 3 years
Adverse reactions including the allergic reactions to drugs
3 years
Treatment costs
Time Frame: 3 years
to assess the total treatment costs in 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Investigators

  • Principal Investigator: Duowu Zou, Doctor, Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 20, 2024

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

May 23, 2024

First Submitted That Met QC Criteria

June 16, 2024

First Posted (Estimated)

June 21, 2024

Study Record Updates

Last Update Posted (Estimated)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 16, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2024-107

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 1 AIP

Clinical Trials on Glucocorticoids

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe