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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020402
Receipt No. R000023563
Scientific Title Improvement of treatment in ulcerative colitis, severe case and moderate case close to severe case, by early use of infliximab
Date of disclosure of the study information 2015/12/30
Last modified on 2020/08/12

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Basic information
Public title Improvement of treatment in ulcerative colitis, severe case and moderate case close to severe case, by early use of infliximab
Acronym Early use of infliximab in severe case and moderate case close to severe case of ulcerative colitis
Scientific Title Improvement of treatment in ulcerative colitis, severe case and moderate case close to severe case, by early use of infliximab
Scientific Title:Acronym Early use of infliximab in severe case and moderate case close to severe case of ulcerative colitis
Region
Japan

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

Objectives
Narrative objectives1 Improvement of treatment in ulcerative colitis, severe case and moderate case close to severe case, by early use of infliximab
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Remission rate at 6 weeks after the initiation of treatment
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
10 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria Ulceraive colitis, severe case or moderate case close to severe case, who is naive to biologics
Key exclusion criteria mild case, moderate case close to mild case
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Mitsuro
Middle name
Last name Chiba
Organization Akita City Hospital
Division name Gastroenterology
Zip code 010-0933
Address Akita
TEL 0188234171
Email mchiba@m2.gyao.ne.jp

Public contact
Name of contact person
1st name Takenori
Middle name
Last name Kawakami
Organization Akita city Hospital
Division name General Administration Division
Zip code 010-0933
Address Akita
TEL 0188234171
Homepage URL
Email mchiba@m2.gyao.ne.jp

Sponsor
Institute IBD Relapse Prevention Team
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 The Ethical Committee of Akita City Hospital
Address 4-30, Matsuoka-machi, Kawamoto, Akita City
Tel 0188234171
Email ro-homn@city.akita.akita.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
2015 Year 12 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 Main results already published
Date of protocol fixation
2010 Year 07 Month 01 Day
Date of IRB
2014 Year 03 Month 28 Day
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2019 Year 09 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Assessment at week 6 since the commencement of a standard induction therapy with infliximab
Clinical remission: disappearance of symptoms including bloody stool
Mucosal healing: disappearance of ulcers and erosions

Management information
Registered date
2015 Year 12 Month 30 Day
Last modified on
2020 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023563

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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