UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038737 |
|---|---|
| Receipt number | R000044167 |
| Scientific Title | A comparison of the effectiveness of medium to long term biologics in moderate to severe ulcerative colitis |
| Date of disclosure of the study information | 2019/12/01 |
| Last modified on | 2023/12/02 14:34:13 |
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Basic information
Public title
A comparison of the effectiveness of medium to long term biologics in moderate to severe ulcerative colitis
Acronym
A comparison of the effectiveness of medium to long term biologics in moderate to severe ulcerative colitis
Scientific Title
A comparison of the effectiveness of medium to long term biologics in moderate to severe ulcerative colitis
Scientific Title:Acronym
A comparison of the effectiveness of medium to long term biologics in moderate to severe ulcerative colitis
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify the positioning of various biologics
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
The rates of remission maintenance rates at 52 weeks, clinical activity index (partial mayo score) 2 or less
Key secondary outcomes
The rates of induction remission at 14 weeks, , clinical activity index (partial mayo score) 2 or less
The rates of maintenance rates at 104 weeks, , clinical activity index (partial mayo score) 2 or less
colectomy-free rate at 52 weeks
mucosal healing rate at 52 weeks, endoscopic mayo score 0 or 1
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
| 15 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
moderate to severe ulcerative colitis receiving biologics
Key exclusion criteria
severe infection
Patients who have undergone or consider abdominal surgery
Patients who are considered ineligible
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Yamada |
Organization
Sakura medical center, Toho university
Division name
interal medicine
Zip code
285-0841
Address
564-1,Shimoshizu, Sakura, Chiba, Japan
TEL
0434628811
taro-dog@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
internal medicine
Zip code
285-0841
Address
564-1,Shimoshizu, Sakura, Chiba, Japan
TEL
0434628811
Homepage URL
taro-dog@sakura.med.toho-u.ac.jp
Sponsor or person
Institute
Toho university
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
Sakura medical center, Toho university
Address
564-1,Shimoshizu, Sakura, Chiba, Japan
Tel
0434628811
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
| 2019 | Year | 12 | Month | 01 | 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
| Delay expected |
Results Delay Reason
Out of Analysis
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
| 2018 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2021 | Year | 12 | Month | 10 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Publication of academic societies
Management information
Registered date
| 2019 | Year | 11 | Month | 29 | Day |
Last modified on
| 2023 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044167
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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