Autoimmune pancreatitis
Conditions
Interventions
Continuation of steroid maintenance therapy until the 36th month from the start of remission induction therapy.
Discontinuation of steroid maintenance therapy at the 6th month from the start of remiss
Sponsors
Division of Gastroenterology, Tohoku University Graduate School of Medicine
Kochi Medical School Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed as autoimmune pancreatitis by diagnostic criteria proposed by the Japanese Pancreas Society in 2006. Without past treatment. 2) With notification of the diagnosis of autoimmune pancreatitis. 3) 20-79 years old. 4) Performance Status : 0 or 1. 5) With adequate oral intake. 6) With adequate organ functions. 7) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) With steroid treatment within 3 months before the start of remission induction therapy. 2) With uncontrolled infection. 3) With chronic hepatitis B or HBs antigen-positive. 4) With malignant neoplasm. 5) With severe complications. 6) Unsuitable for this clinical trial due to some complications or other critial medical phenomena. 7) Pregnant, breast-feeding, with chance of pregnancy, or expecting to give birth. 8) With severe mental disorders. 9) Judged as being unsuitable for this trial by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 36-month relapse free rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse-free duration, quality of life, and adverse events. | — |
Countries
Japan
Contacts
Public ContactAtsushi Masamune
Tohoku University Graduate School of Medicine Division of Gastroenterology
Outcome results
None listed