Remission maintenance treatment of ulcerative colitis with tacrolimus in azathioprine-intolerant patients: a randomized comparative trial of 5-aminosalicylic acid (5-ASA) monotherapy versus 5-ASA and tacrolimus combination therapy.

Remission maintenance treatment of ulcerative colitis with tacrolimus in azathioprine-intolerant patients: a randomized comparative trial of 5-aminosalicylic acid (5-ASA) monotherapy versus 5-ASA and tacrolimus combination therapy. - A randomized trial of 5-ASA vs. 5-ASA and tacrolimus in maintenance of ulcerative colitis.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003785

Enrollment

Registered

2010-07-01

Start date

2010-07-01

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

Ulcerative colitis

Interventions

5-aminosalicylic acid monotherapy arm: 5-aminosalicylic acid is administered to subjects during the study period (for 48 weeks). 5-aminosalicylic acid monotherapy and tacrolimus arm: 5-aminosalic

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. A patient who is diagnosed as ulcerative colitis. 2. A patient who has been induced to remission with tacrolimus and has been administered tacrolimus about 3 months. 3. A patient who is expected to suffer from severe adverse effect of azathioprine by reason of his (her) past history or other. (judged by a doctor in charge) 4. A patient who is 16 to 64 years old and has written his (her) signature to a document for agreement. (If a patient is under 20 years old, a signature of his (her) legal representative is necessary.)

Exclusion criteria

Exclusion criteria: 1. A patient who has had hypersensitivity to tacrolimus or ingredients of tacrolimus formulation. 2. A patient who is in treatment of cyclosporine or bozentan. 3. A patient who is in treatment of potassium sparing diuretics. 4. A patient who is pregnant, may be pregnant, breast-feeds or hopes to be pregnant in the study period. 5. A patient who is determined as ineligible for a subject in this study by a doctor in charge or others.

Design outcomes

Primary

Measure	Time frame
Remission rate at 12 weeks after the start of protocol treatment (Full Analysis Set; Discontinuation of protocol treatment is accounted to be non-remission.)	—

Secondary

Measure	Time frame
Evaluation of efficiency: Remission ratios at 24 and 48 weeks after start of protocol treatment, Ratio of the protocol continuation, Clinical activity in both the Lichtiger's CAI and the Mayo's DAI, Dosage of concomitant steroid, etc. Evaluation of safety: Occurrences of adverse event, abnormal values in blood test, and so on.	—

Countries

Japan

Contacts

Public ContactKen Fukunaga

Hyogo College of Medicine Department of Internal medicine, Division of Lower Gastroenterology

kebe@hyo-med.ac.jp0798-45-6662

Outcome results

None listed

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