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

Launched by RUIJIN HOSPITAL · Jun 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how to prevent a disease called Type 1 Autoimmune Pancreatitis (AIP) from coming back in patients who are at high risk for recurrence. AIP is a rare condition that affects the pancreas, and while a common treatment involves the use of glucocorticoids (GC), some patients may still experience a return of their symptoms. The trial will explore whether combining GC with another medication called mycophenolate mofetil (MMF) can help lower the chances of this happening. MMF is known to have fewer side effects compared to other treatments.

To participate in this trial, individuals must be at least 18 years old and have been diagnosed with Type 1 AIP, showing specific signs that indicate a high risk of their disease returning. This includes having elevated levels of a certain protein in their blood and ongoing symptoms related to the disease. Participants should be willing to take oral medications and cooperate with the study procedures. It’s important to note that women who could become pregnant must use contraception during the study. Those who join can expect close monitoring and support throughout the trial as researchers gather information to help improve future treatments for this condition.

Gender

ALL

Eligibility criteria

• 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