Actively Recruiting
A Trial on the Recurrence Free Survival Rate of Type I AIP With High-risk of Recurrence
Led by Ruijin Hospital · Updated on 2024-06-21
86
Participants Needed
1
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Trial on the Recurrence Free Survival Rate of Type I AIP With High-risk of Recurrence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Willingness to follow all study procedures
- Age 18 years or older
- Confirmed type I autoimmune pancreatitis with high risk of recurrence, including any of: IgG4 > 4 times upper limit before treatment, high serum IgG4 after glucocorticoid treatment, pancreatic diffuse enlargement, IgG4-related sclerosing cholangitis with proximal bile duct involvement, or extrapancreatic organ involvement
- Indications for treatment such as symptoms of pancreatic or extrapancreatic involvement or asymptomatic individuals with severe potential organ damage
- Ability to take oral medications and cooperate with the study
- Women of reproductive age must use contraception for at least one month before screening and throughout the study period
You will not qualify if you...
- Pregnant or breastfeeding women
- Inability or refusal to sign informed consent
- History of mental illness
- Allergy to study medications
- Presence of malignant tumors
- Active infections such as hepatitis or tuberculosis
- Severe uncontrolled diseases like heart failure or respiratory failure
- Use of glucocorticoids or immunosuppressants for other illnesses within the last 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
X
XIaonan Shen, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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