UMIN-CTR Clinical Trial

Basic information
Public title	Monitoring of the response for patients under fasting and fed conditions in refractory ulcerative colitis
Acronym	Monitoring of the response to the adalimumab therapy for the patients with moderate to severe corticosteroids-refractory ulcerative colitis
Scientific Title	Monitoring of the response for patients under fasting and fed conditions in refractory ulcerative colitis
Scientific Title:Acronym	Monitoring of the response to the adalimumab therapy for the patients with moderate to severe corticosteroids-refractory ulcerative colitis
Region	Japan

Condition
Condition	ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the predictors of monitoring in patients of steroid-refractory ulcerative colitis with adalimumab therapy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	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
Key secondary outcomes	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.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key 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.
Key exclusion criteria	(1)proctitis (2)patients with severe allergy of adalimumab 1)patients with severe infection 2)patients with tuberculosis
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yasuo Middle name Last name Suzuki
Organization	Sakura Medical center, Toho university
Division name	Gastroenterology
Zip code	285-0841
Address	564-1,Shimoshizu,Sakura city,Chiba
TEL	81-43-462-8811
Email	yasuo-suzuki@sakura.med.toho-u.ac.jp

Public contact
Name of contact person	1st name Akihiro Middle name Last name Yamada
Organization	Sakura medical center,Toho university
Division name	gastroenterology
Zip code	285-0841
Address	564-1,shimoshizu,Sakura city,Chiba
TEL	81-43-462-8811
Homepage URL
Email	taro-dog@sakura.med.toho-u.ac.jp

Sponsor
Institute	Sakura Medical center,Toho university
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Sakura medical center, Toho university
Address	564-1,shimoshizu, sakura
Tel	+81-43-462-8811
Email	taro-dog@sakura.med.toho-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 03 Month 12 Day
Date of IRB
Anticipated trial start date	2014 Year 04 Month 30 Day
Last follow-up date	2015 Year 04 Month 29 Day
Date of closure to data entry	2015 Year 05 Month 31 Day
Date trial data considered complete	2015 Year 05 Month 31 Day
Date analysis concluded

Other
Other related information	enrolling

Management information
Registered date	2014 Year 04 Month 13 Day
Last modified on	2021 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015996