A study of infliximab administration method for tacrolimus-resistant active ulcerative colitis

A study of infliximab administration method for tacrolimus-resistant active ulcerative colitis - A study of infliximab administration method for tacrolimus-resistant active ulcerative colitis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013716

Enrollment

Registered

2014-04-15

Start date

2014-04-15

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

After administrating tacrolimus and infliximab for 6 weeks,tacrolimus is tapered to 0mg. Infliximab monotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who have been diagnosed with ulcerative colitis based on the diagnostic criteria of the Japanese Ministry of Health, Labour and Welfare. Tacrolimus-resistance 16 years of age and older at the time of registration. Patients who have been signed informed consent document before entering this study.

Exclusion criteria

Exclusion criteria: Patients applied to the medically contraindicated of infliximab Patients during pregnancy Patients are taking concomitant any other biological therapies or cyclosporine Patients are determined to be inappropriate for administration of infliximab by doctors

Design outcomes

Primary

Measure	Time frame
rate of mucosal healing	—

Secondary

Measure	Time frame
remission rate improvement rate steroid-sparing effect safety	—

Countries

Japan

Contacts

Public ContactReiko Kunisaki

Yokohama City University Medical Center IBD Center

kunisakireiko@gmail.com045-261-5656

Outcome results

None listed

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