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Randomized controlled trial which examines whether resuming steroid can prevent clinical relapse in the patients with asymptomatic high levels of serum IgG after ceasing steroid therapy for autoimmune pancreatitis

Randomized controlled trial which examines whether resuming steroid can prevent clinical relapse in the patients with asymptomatic high levels of serum IgG after ceasing steroid therapy for autoimmune pancreatitis - Steroid resuming study after serological relapse in AIP

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003804
Enrollment
20
Registered
2010-06-25
Start date
2010-05-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

autoimmune pancreatitis

Interventions

Prednisolone at a dose of 10mg/day is started. The dose is taperd by 2.5mg every 8-10 weeks until reaching 5mg/day. Maintenance therapy at a dose of 5 mg/day is continued. Resuming or increasing pr

Sponsors

Department of Gastroenterology, University of Tokyo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Among patients who joined our clinical trial "Follow-up research on prognois of autoimmune pancreatitis after tapering steroid (UMIN000003798)", those who show serological relapse (defined as IgG>1600 mg/dl) during tapering steroid or after its cessation are enrolled in this study.

Exclusion criteria

Exclusion criteria: Patients who do not give their informed consent are excluded.

Design outcomes

Primary

MeasureTime frame
Patients with AIP, who show serological relapse (defined as IgG>1600mg/dl) after their maintenance steroid dose is tapered or ceased, are enrolled in this study. They are divided into 2 groups, that is, 1) steroid resuming group, and 2) obsevation group. The main outcome is to clarify frequency and severity of pancreatic or extrapancreatic clinical relapse in each group within 3 years.

Secondary

MeasureTime frame
Morphological change of pancreas Pancreatic endocrine function Occurrence of malignancy Survival time

Countries

Japan

Contacts

Public ContactKenji Hirano

University of Tokyo Clinical Research Support Center

khirano-tky@umin.ac.jp03-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026