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

NCT06468709 | Recruiting Phase 4 DMC

• 1 other identifier: KY2024-107
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 AIP

Keywords

Type 1 AIP; Recurrence; Glucocorticoids; MMF

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (5)

• Evaluate the impact on endocrine function

  3 years

• Evaluate the impact of external secretion pancreatic function

  3 years

• Assess the impact on the incidence of malignant tumors

  3 years

• Adverse reactions

  3 years

• Treatment costs

  3 years

Study Arms (2)

Glucocorticoids group

ACTIVE COMPARATOR

Induction therapy: Prednisone 30mg/d, lasting for 4 weeks, then decreasing by 5mg/d every 2 weeks until maintained at 5mg/d

Drug: Glucocorticoids

Glucocorticoids+MMF group

EXPERIMENTAL

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

Interventions

Glucocorticoids DRUG

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

Also known as: Prednisone

Glucocorticoids group

Glucocorticoids+MMF DRUG

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

Also known as: Prednisone and MMF

Glucocorticoids+MMF group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;
• Able to persist and cooperate with research interventions, such as oral medication;
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Autoimmune Pancreatitis; Recurrence

Interventions

Glucocorticoids; Prednisone

Condition Hierarchy (Ancestors)

Pancreatitis, Chronic; Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Duowu Zou, Doctor

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

XIaonan Shen, Doctor

CONTACT

18817554263; hgssldsxn@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology Department

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 21, 2024
• Study Start: June 20, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)