NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001818

Registered date:31/03/2009

A multicenter randomized controlled trial of steroid maintenance therapy for preventing relapse of autoimmune pancreatitis.

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedAutoimmune pancreatitis
Date of first enrollment2009/04/01
Target sample size140
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)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 remission induction therapy. From 7th to 36th month, closely follow-up without steroid treatment.

Outcome(s)

Primary Outcome36-month relapse free rate.
Secondary OutcomeRelapse-free duration, quality of life, and adverse events.

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteria1) 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.

Related Information

Contact

public contact
Name Atsushi Masamune
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan Japan
Telephone 022-717-7171
E-mail suizo@gastroente.med.tohoku.ac.jp
Affiliation Tohoku University Graduate School of Medicine Division of Gastroenterology
scientific contact
Name Tooru Shimosegawa
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan Japan
Telephone 022-717-7171
E-mail suizo@gastroente.med.tohoku.ac.jp
Affiliation Tohoku University Graduate School of Medicine Division of Gastroenterology