Type 1 AIPPhase 4AIP；MMFNCT06468709
A Trial on the Remission Rates of Type I Autoimmune Pancreatits With High-risk of Recurrence
A Phase 4 study testing Glucocorticoids and Glucocorticoids+MMF in people with Type 1 AIP, run by Ruijin Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 AIP
- What is being tested?
- Glucocorticoids and Glucocorticoids+MMF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2024to 30 Sep 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Shen, Doctor, 18817554263, hgssldsxn@163.com
About this study
Official title: A Multicenter, Prospective, Randomized Controlled Trial on the Remission Rate of Type I AIP With High-risk of Recurrence Patients Receiving Glucocorticoid Maintenance Therapy/Glucocorticoid Combined With Mycophenolate Mofetil 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.
Read the 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.
Participants will be followed for a total of 36 months. An initial analysis of 12-month follow-up data is planned, with findings intended for dissemination through scientific presentations and/or publication as preliminary results. Follow-up will continue through Month 36, after which the final analysis and dissemination of results are planned.
Peripheral blood samples will be collected during the study for exploratory mechanistic analyses of immune-cell populations and circulating biomarkers. These analyses will characterize biological changes during treatment and explore their associations with disease remission, relapse, and treatment response.
- Conditions
- Type 1 AIP
- Being tested
- Glucocorticoids, Glucocorticoids+MMF
- Keywords
- Type 1 AIP, Recurrence, Glucocorticoids, MMF
- Medical subject headings
- Autoimmune Pancreatitis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucocorticoidsDrug
Also called Prednisone
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
Glucocorticoids+MMFDrug
Also called Prednisone and 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
| Study group | Role | What they receive |
|---|---|---|
| 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.
Peripheral blood samples will also be collected for exploratory mechanistic analyses. Receives: 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.
Peripheral blood samples will also be collected for exploratory mechanistic analyses. Receives: Drug: Glucocorticoids+MMF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 is defined as the proportion of patients achieving complete or partial resolution of clinical symptoms, normalization or significant improvement of imaging findings, and reduction of serum IgG4 levels. Remission rate will be compared between the glucocorticoid monotherapy group and the glucocorticoid plus MMF combination therapy group within 3 years of follow-up.
Measured: 3 years
Disease remission rate within 1 years in high-risk type I AIP patients receiving glucocorticoid monotherapy versus glucocorticoid combined with MMF maintenance therapy
Disease remission is defined as the proportion of patients achieving complete or partial resolution of clinical symptoms, normalization or significant improvement of imaging findings, and reduction of serum IgG4 levels. Remission rate will be compared between the glucocorticoid monotherapy group and the glucocorticoid plus MMF combination therapy group within 1 years of follow-up.
Measured: 1 year
Secondary outcomes (5)
Changes in endocrine function
Endocrine function will be assessed by the following measures: (1) incidence of new-onset diabetes mellitus during the 3-year follow-up period; (2) change from baseline in HbA1c levels; (3) change from baseline in C-peptide levels; (4) change from baseline in insulin secretion capacity.
Measured: 3 years
Changes in external secretion pancreatic function
Pancreatic exocrine function will be assessed by the following measures: (1) incidence of pancreatic exocrine insufficiency during the 3-year follow-up period; (2) change from baseline in serum vitamin levels (including vitamin A, D, E); (3) change from baseline in serum 25-OH-D3 levels.
Measured: 3 years
Incidence of malignant tumors
Incidence of newly diagnosed malignant tumors, specifically gastrointestinal tumors (including esophageal, gastric, pancreatic, and colorectal tumors), detected by endoscopic examination during the 3-year follow-up period. All tumor diagnoses will be confirmed by histopathological evaluation.
Measured: 3 years
Adverse reactions
Adverse reactions including the allergic reactions to drugs
Measured: 3 years
Treatment costs
to assess the total treatment costs in 3 years
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start30 Jun 2024
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 AIPStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Hospital of China Medical University, Tianjin Medical University General Hospital, Zunyi Medical College, The First People's Hospital of Yunnan, Anhui Provincial Hospital, The First Affiliated Hospital of Nanchang University, Zhongshan Hospital Affiliated to Xiamen University, Second Affiliated Hospital of Soochow University, Shengjing Hospital, The Affiliated Hospital of Qingdao University, Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, The Third Affiliated Hospital of Soochow University, First Affiliated Hospital of Zhejiang University
- Responsible party
- Principal investigator, ZOU DUOWU, Ruijin Hospital
- Investigators
- Duowu Zou, Doctor, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468709
- Sponsor's protocol ID
- KY2024-107
- Acronym
- AIP；MMF
- Status last verified
- Oct 2026
- First submitted
- 23 May 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Controlled Trial on the Remission Rate of Type I AIP With High-risk of Recurrence Patients Receiving Glucocorticoid Maintenance Therapy/Glucocorticoid Combined With Mycophenolate Mofetil Maintenance Therapy
- ClinicalTrials.gov ID
- NCT06468709
- Acronym / sponsor ID
- AIP；MMF / KY2024-107
- Conditions
- Type 1 AIP
- Keywords
- Type 1 AIP, Recurrence, Glucocorticoids, MMF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- First Hospital of China Medical University, Tianjin Medical University General Hospital, Zunyi Medical College, The First People's Hospital of Yunnan, Anhui Provincial Hospital, The First Affiliated Hospital of Nanchang University, Zhongshan Hospital Affiliated to Xiamen University, Second Affiliated Hospital of Soochow University, Shengjing Hospital, The Affiliated Hospital of Qingdao University, Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, The Third Affiliated Hospital of Soochow University, First Affiliated Hospital of Zhejiang University
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Participants will be followed for a total of 36 months. An initial analysis of 12-month follow-up data is planned, with findings intended for dissemination through scientific presentations and/or publication as preliminary results. Follow-up will continue through Month 36, after which the final analysis and dissemination of results are planned.
Peripheral blood samples will be collected during the study for exploratory mechanistic analyses of immune-cell populations and circulating biomarkers. These analyses will characterize biological changes during treatment and explore their associations with disease remission, relapse, and treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucocorticoids group | Active comparator | Drug: GlucocorticoidsInduction therapy: Prednisone 30mg/d, lasting for 4 weeks, then decreasing by 5mg/d every 2 weeks until maintained at 5mg/d. Peripheral blood samples will also be collected for exploratory mechanistic analyses. |
| Glucocorticoids+MMF group | Experimental | Drug: Glucocorticoids+MMFGC: 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. Peripheral blood samples will also be collected for exploratory mechanistic analyses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlucocorticoidsAlso: PrednisoneThe 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 | Drug | Glucocorticoids group |
| Glucocorticoids+MMFAlso: Prednisone and MMFThe 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 | Drug | Glucocorticoids+MMF group |
Primary outcome
Disease remission rate within 3 years in high-risk type I AIP patients receiving glucocorticoid monotherapy versus glucocorticoid combined with MMF maintenance therapy
Time frame: 3 years
Disease remission is defined as the proportion of patients achieving complete or partial resolution of clinical symptoms, normalization or significant improvement of imaging findings, and reduction of serum IgG4 levels. Remission rate will be compared between the glucocorticoid monotherapy group and the glucocorticoid plus MMF combination therapy group within 3 years of follow-up.
Disease remission rate within 1 years in high-risk type I AIP patients receiving glucocorticoid monotherapy versus glucocorticoid combined with MMF maintenance therapy
Time frame: 1 year
Disease remission is defined as the proportion of patients achieving complete or partial resolution of clinical symptoms, normalization or significant improvement of imaging findings, and reduction of serum IgG4 levels. Remission rate will be compared between the glucocorticoid monotherapy group and the glucocorticoid plus MMF combination therapy group within 1 years of follow-up.
5 secondary outcomes
Changes in endocrine function
Time frame: 3 years
Changes in external secretion pancreatic function
Time frame: 3 years
Incidence of malignant tumors
Time frame: 3 years
Adverse reactions
Time frame: 3 years
Treatment costs
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No. No plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Duowu Zou, Doctor principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glucocorticoids and Glucocorticoids+MMF in people with Type 1 AIP, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact XIaonan Shen, Doctor (18817554263, hgssldsxn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease remission rate within 3 years in high-risk type I AIP patients receiving glucocorticoid monotherapy versus glucocorticoid combined with MMF maintenance therapy (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.