Monitoring of the response for patients under fasting and fed conditions in refractory ulcerative colitis

Monitoring of the response for patients under fasting and fed conditions in refractory ulcerative colitis - Monitoring of the response to the adalimumab therapy for the patients with moderate to severe corticosteroids-refractory ulcerative colitis

Status

Recruiting

Phases

Phase 1

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000013701

Enrollment

Registered

2014-04-30

Start date

2014-04-30

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 with refractory to the previous treatment, miderate to severe ulcerative colitis (2)candidate has to agree to be entolled for the study under sufficient writtern informed consent.

Exclusion criteria

Exclusion criteria: (1)proctitis (2)patients with severe allergy of adalimumab 1)patients with severe infection 2)patients with tuberculosis

Design outcomes

Primary

Measure	Time frame
The remission rate (Mayo clinical activity score:Mayo score)at 52 weeks after the adalimumab treatment, who achived the clinical remission or response and the remission or response in a non-invensive monitering score with adalimumab therapy from 2 to 16 weeks	—

Secondary

Measure	Time frame
To evaluate the predictors of the patients in a clinical remission at 52weeks, who achived the remission or response of a non-invensive monitering after adalimumab treatment from 2 to 16weeks. To evaluate the timing of the patients in a clinical remission at 52 weeks, when we should assese of the response with the adalimumab therapy.	—

Countries

Japan

Contacts

Public ContactAkihiro Yamada

Sakura medical center,Toho university gastroenterology

taro-dog@sakura.med.toho-u.ac.jp81-43-462-8811

Outcome results