UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009678 |
|---|---|
| Receipt number | R000011311 |
| Scientific Title | The investigation of drug withdrawal with immunosuppressant and biologics for ulcerative colitis patients |
| Date of disclosure of the study information | 2013/01/15 |
| Last modified on | 2024/07/25 22:18:01 |
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Basic information
Public title
The investigation of drug withdrawal with immunosuppressant and biologics for ulcerative colitis patients
Acronym
The investigation of drug withdrawal for ulcerative colitis patients
Scientific Title
The investigation of drug withdrawal with immunosuppressant and biologics for ulcerative colitis patients
Scientific Title:Acronym
The investigation of drug withdrawal for ulcerative colitis patients
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate if immunosuppressant or biologics are necessary for maintenance therapy for the patients of ulcerative colitis who are diagnosed as remission phase. We also investigate if clinical symptomatic remission or endoscopic mucosal healing are useful indicator for standard of discontinue of these drugs.
Basic objectives2
Others
Basic objectives -Others
Observation study for discontinue of immunosuppressant or biologics for maintenance of remission of ulcerative colitis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Endoscopic findings for 12, 24, 36 months from the start of this study.
Key secondary outcomes
Clinical activity index (CAI) for every 3 month from the start of this study.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients of ulcerative colitis who are maintained by using biologics and/or immunosuppressant, and who are diagnosed as clinical remission and confirmed as mucosal healing by endoscopy. All patients should be agreed the burden of this study.
Key exclusion criteria
The patients who are impaired consciousness and do not have the ability of agreement.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
Address
465 Kajiicho Hirokoji, Kawaramachidori, Kamigyo-ku, Kyoto
TEL
075-251-5519
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohisa Takagi |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
Address
465 Kajiicho Hirokoji, Kawaramachidori, Kamigyo-ku, Kyoto
TEL
075-251-5519
Homepage URL
takatomo@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
京都府立医科大学（京都府）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 15 | 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
| 2012 | Year | 12 | Month | 29 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 29 | Day |
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is prospective and case controlled study. The patients is in remission phase of ulcerative colitis who are treated by immunosuppressant or biologics.
Management information
Registered date
| 2013 | Year | 01 | Month | 02 | Day |
Last modified on
| 2024 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011311
