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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013701
Receipt No. R000015996
Scientific Title Monitoring of the response for patients under fasting and fed conditions in refractory ulcerative colitis
Date of disclosure of the study information 2014/04/30
Last modified on 2021/04/18

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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/ctr_e/ctr_view.cgi?recptno=R000015996

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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