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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007256
Receipt No. R000008552
Scientific Title Study for predictors of response to infliximab therapy for ulcerative colitis
Date of disclosure of the study information 2012/02/10
Last modified on 2016/02/09

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Basic information
Public title Study for predictors of response to infliximab therapy for ulcerative colitis
Acronym Study for predictors of response to infliximab therapy for ulcerative colitis
Scientific Title Study for predictors of response to infliximab therapy for ulcerative colitis
Scientific Title:Acronym Study for predictors of response to infliximab therapy for ulcerative colitis
Region
Japan

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

Objectives
Narrative objectives1 The aims of this study are to assess efficacy of infliximab in ulcerative colitis and to find predictors of response to infliximab.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Remission rate at week 10 and 54
(Lichitiger index)
Key secondary outcomes

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

Not applicable
Gender Male and Female
Key inclusion criteria Ulcerative colitis
(moderate-to-severe)
Key exclusion criteria 1)Patient whose age below 16 years old
2)Patients who cannot been kept in the treatment with infliximab
(Patients with serious infection, active tuberculosis, history of allergy to ingredients of infliximab or to proteins derived from mouse, demyelinating diseases and its past history, congestive heart failure)
3)Patients who are pregnant
4)Patients who are inadequate to enter this trial due to the other reasons by physician's judgments
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Reiko Kunisaki
Organization Yokohama City University Medical Center
Division name Inflammatory Bowel Disease Center
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama, Kanagawa, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Yokohama City University Medical Center
Division name Inflammatory Bowel Disease Center
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama, Kanagawa, Japan
TEL
Homepage URL
Email

Sponsor
Institute Kanagawa Crohn Disease Treatment Study Group
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
Address
Tel
Email

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
2012 Year 02 Month 10 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 Completed
Date of protocol fixation
2011 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
2013 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational trial

Management information
Registered date
2012 Year 02 Month 09 Day
Last modified on
2016 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008552

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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