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

UMIN ID: UMIN000001818

Registered date:31/03/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Autoimmune pancreatitis
• Date of first enrollment: 2009/04/01
• Target sample size: 140
• Countries of recruitment: Japan
• Study type: Interventional

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 Outcome: 36-month relapse free rate.
• Secondary Outcome: Relapse-free duration, quality of life, and adverse events.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Division of Gastroenterology, Tohoku University Graduate School of Medicine
• Secondary Sponsor: Kochi Medical School Hospital
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare