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Optimizing therapeutic strategies: a prospective exploratory pilot study of different B-cell clearance therapies versus glucocorticoids in the induction and maintenance of refractory or relapsed autoimmune pancreatitis

Optimizing therapeutic strategies: a prospective exploratory pilot study of different B-cell clearance therapies versus glucocorticoids in the induction and maintenance of refractory or relapsed autoimmune pancreatitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107573
Enrollment
Unknown
Registered
2025-08-14
Start date
2025-08-18
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune pancreatitis

Interventions

High-dose hormone group:Receive conventional high-dose prednisone treatment [0.6-0.8] mg/kg/d
Medium dose hormone+immunosuppressant group:Receive moderate doses of prednisone (0.4-0.6) mg/kg/d in combination with immunosuppressants (such as azathioprine or mycophenolate mofetil)
Rituximab group:Receiving treatment with the B-cell clearance therapy drug rituximab
Inebilizumab group:Receiving treatment with the B-cell clearance therapy drug Inebilizumab

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: When patients meet all of the following conditions, they can choose to enter the study (1) Patients between the ages of 18 and 75, regardless of gender, who meet the diagnostic criteria for type 1 AIP: The diagnostic criteria are based on the Chinese guidelines for the diagnosis and treatment of autoimmune pancreatitis (Shanghai, 2023); (2) Recurrent AIP patients: Refers to patients who experience recurrence after receiving standard treatment (such as glucocorticoids/and immunosuppressants), indicating evidence of disease recurrence during follow-up after achieving remission, including laboratory/imaging abnormalities that suggest the recurrence of affected organ damage.

Exclusion criteria

Exclusion criteria: When a patient has any of the following conditions, they cannot be selected to enter the study: (1) Combining clinical conditions similar to IgG4, such as Sjogren's syndrome, polyangitis granulomatous sarcoidosis, eosinophilic granulomatous polyangitis, etc; (2) Merge malignant tumors; (3) Merge severe and irreversible organ damage; (4) Combination of active infections (defined as infections requiring intravenous antibiotic treatment or hospitalization, including active tuberculosis infections and HBsAg (+) patients who have not received anti HBV treatment); (5) Pregnancy or breastfeeding; (6) The researchers believe that it is not suitable for inclusion in this study.

Design outcomes

Primary

MeasureTime frame
Relapse rate after re-induction;

Secondary

MeasureTime frame
Relapse rate;Incidence of AE;

Countries

China

Contacts

Public ContactAiming Yang

Peking Union Medical College Hospital

yangaimingpumc@163.com+86 10 6915 5017

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026