UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045241 |
|---|---|
| Receipt number | R000051682 |
| Scientific Title | Analysis of mucosal concentrations of biologics in Crohn's disease |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2025/02/25 09:17:40 |
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Basic information
Public title
Analysis of mucosal concentrations of biologics in Crohn's disease
Acronym
Analysis of mucosal concentrations of biologics in Crohn's disease
Scientific Title
Analysis of mucosal concentrations of biologics in Crohn's disease
Scientific Title:Acronym
Analysis of mucosal concentrations of biologics in Crohn's disease
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the mucosal concentrations of biologics
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between mucosal healing and mucosal concentrations
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Ileal or ileocolonic Crohn's disease
2. Recieving biologics (infliximab, adalimumab, ustekinumab, vedolizumab).
3. Plan to undergo balloon-assisted enteroscopy for intestinal evaluation.
Key exclusion criteria
1. Colonic Crohn's disease
2. Patients with artificial anus
3. Patients who cannot insert a balloon assisted enteroscopy
4. Patients with serious intestinal infections
5. Patients with a history of malignant tumors
6. Patients with tuberculosis or hepatitis B activity
7. Pregnant patients
8. Patients with bleeding tendency
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kento |
| Middle name | |
| Last name | Takenaka |
Organization
Tokyo Medical and Dental University
Division name
Gastroenterology and Hepatology
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5877
ktakenaka.gast@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Kento |
| Middle name | |
| Last name | Takenaka |
Organization
Tokyo Medical and Dental University
Division name
Gastroenterology and Hepatology
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5877
Homepage URL
ktakenaka.gast@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental 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
IRB of TMDU
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5096
ktakenaka.gast@tmd.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
| 2021 | Year | 09 | 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
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
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2021 | Year | 08 | Month | 24 | Day |
Last modified on
| 2025 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051682
