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A randomized controlled study of different B cell depletion therapies versus glucocorticoids in the induction and maintenance treatment of autoimmune pancreatitis

A randomized controlled study of different B cell depletion therapies versus glucocorticoids in the induction and maintenance treatment of autoimmune pancreatitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102364
Enrollment
Unknown
Registered
2025-05-13
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-19

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 GC group:High-dose GC
Medium-dose GC group:Medium-dose GC
Low-dose GC group:Low-dose GC

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients aged between 18 and 75 years, regardless of gender, who meet the diagnostic criteria for type 1 autoimmune pancreatitis (AIP): The diagnostic criteria are based on the guidelines for the diagnosis and treatment of autoimmune pancreatitis in China (Shanghai, 2023); (2) Patients diagnosed with type 1 AIP who are initially receiving treatment for induction of remission and have not previously received treatment with hormones, immunosuppressants, or B cell-targeting biological agents.

Exclusion criteria

Exclusion criteria: 1. Comorbidities of diseases similar to IgG4: such as Sjogren's syndrome, granulomatosis with polyangiitis, eosinophilic granulomatosis with polyangiitis, etc.; 2. Presence of malignant tumors; 3. Presence of severe and irreversible organ damage: referring to severely compromised organ function due to disease or previous treatment (meeting any of the following criteria), with particular attention to damage of the following organs (including but not limited to): liver, kidneys, heart, central nervous system; (1) Liver: Child-Pugh classification >= B or MELD score >= 15; (2) Kidneys: CKD stage 4-5 (eGFR = III or echocardiogram suggesting LVEF <= 35%; (4) Central nervous system: GCS score less than 15; 4. Presence of active infection (defined as an infection requiring intravenous antibiotic treatment or hospitalization); 5. Pregnancy or breastfeeding; 6. The investigator deems the subject unsuitable for inclusion in this study.

Design outcomes

Primary

MeasureTime frame
The remission rate in week 12;

Secondary

MeasureTime frame
Relief rates in weeks 24 and 52;

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