Construction of therapeutic evidence for active ulcerative colitis requiring hospitalization

Construction of therapeutic evidence for active ulcerative colitis requiring hospitalization - None

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000041062

Enrollment

300

Registered

2020-07-10

Start date

2020-07-10

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who met the criteria for ulcerative colitis 2) Inpatients who have a diagnosis criteria at the time of enrollment and have moderate or severe activity 3) Patients who will be treated with steroids, GMA, Tacrolimus, anti-ANF agents, Tofacitinib, vedolizumab, or ustekinumab 4) Patients over 16 years old 5)Patients who have contents for this study

Exclusion criteria

Exclusion criteria: 1) Outpatients 2) Colitis other than ulcerative colitis (e.g. infectious colitis) 3) Patients who will receive total colectomy 4) Patients judged to be inappropriate for inclusion in this study 5) Patients participate other clinical trial.

Design outcomes

Primary

Measure	Time frame
On December 27, 2022, the evaluation items were fixed as follows. Clinical remission rate at Day 7 and Day 14	—

Secondary

Measure	Time frame
On December 27, 2022, the evaluation items were fixed as follows. 1 Clinical improvement rate on days 7 and 14 2 Difference between baseline and PRO on Days 3, 7, and 14 3 Surgery rate within 28 days 4 Proportion of cases in which treatment was changed within 28 days 5 Infectious disease that developed within 28 days 6 Adverse effects other than infections that developed within 28 days For the above, we evaluated the efficacy and safety of steroids, the first advanced therapy after hospitalization, and the second advanced therapy, divided into acute severe UC, severe, and moderate. In addition, the remission rate, improvement rate, treatment change rate, and surgery rate of steroid use cases and advanced therapy were evaluated separately for steroid use cases and non-use cases before hospitalization.	—

Measure

Time frame

On December 27, 2022, the evaluation items were fixed as follows. 1 Clinical improvement rate on days 7 and 14 2 Difference between baseline and PRO on Days 3, 7, and 14 3 Surgery rate within 28 days 4 Proportion of cases in which treatment was changed within 28 days 5 Infectious disease that developed within 28 days 6 Adverse effects other than infections that developed within 28 days For the above, we evaluated the efficacy and safety of steroids, the first advanced therapy after hospitalization, and the second advanced therapy, divided into acute severe UC, severe, and moderate. In addition, the remission rate, improvement rate, treatment change rate, and surgery rate of steroid use cases and advanced therapy were evaluated separately for steroid use cases and non-use cases before hospitalization.

—

Countries

Japan

Contacts

Public ContactMakoto Naganuma

Kansai Medical University Department of Gastroenterology and Hepatology

naganuma@hirakata.kmu.ac.jp072-804-0101

Outcome results