UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050116 |
|---|---|
| Receipt number | R000057093 |
| Scientific Title | Retrospective study of usefulness and safety of ustekinumab and vedolizumab in patients with inflammatory bowel diseases |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/01/24 06:10:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Retrospective study of usefulness and safety of ustekinumab and vedolizumab in patients with inflammatory bowel diseases
Acronym
Retrospective study of usefulness and safety of ustekinumab and vedolizumab in patients with inflammatory bowel diseases
Scientific Title
Retrospective study of usefulness and safety of ustekinumab and vedolizumab in patients with inflammatory bowel diseases
Scientific Title:Acronym
UV in IBD Retrospective Study
Region
| Japan |
Condition
Condition
inflammatory bowel diseases
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
usefulness and safety of ustekinumab and vedolizumab in patients with inflammatory bowel diseases
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
persistence of UST and VED until one year
Key secondary outcomes
1. proportion of patients in clinical remission until half a year and a year
2. proportion of patients in clinical response until half a year and a year
3. proportion of patients in steroid-free clinical remission until half a year and a year
4. Rates of negative fecal calprotectin until half a year and a year
5. time-course changes of inflammatory markers
6. proportion of patients in clinical remission after chages of treatment
7. proportion of patients in clinical response after chages of treatment
8. safety during observationa period
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients treated with ustekinumab and / or vedolizumab
Key exclusion criteria
1. patients who access us to refuse entry in this study
2. patienst without precise clinical record
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Kato |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
350-8550
Address
1981, Kamoda, Kawagoe City, Saitama, Japan
TEL
049-228-3564
skato@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Kato |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
350-8550
Address
1981, Kamoda, Kawagoe City, Saitama, Japan
TEL
049-228-3564
Homepage URL
skato@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB in Saitama Medical Center
Address
1981, Kamoda, Kawagoe City, Saitama, Japan
Tel
049-228-3500
irb-smc@saitama-med.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
| 2023 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 01 | Month | 24 | Day |
Last modified on
| 2023 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057093
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
