UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020402 |
|---|---|
| Receipt number | 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 05:10:06 |
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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
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
mchiba@m2.gyao.ne.jp
Sponsor or person
Institute
IBD Relapse Prevention Team
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023563
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
