UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054083 |
|---|---|
| Receipt number | R000061757 |
| Scientific Title | Investigation of preference, clinical efficacy and trough concentration of vedolizumab by patient-oriented switching to intravenous (IV) or subcutaneous (SC) injection in patients with ulcerative colitis |
| Date of disclosure of the study information | 2024/06/07 |
| Last modified on | 2024/06/07 05:51:12 |
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Basic information
Public title
Investigation of preference, clinical efficacy and trough concentration of vedolizumab by patient-oriented switching to intravenous (IV) or subcutaneous (SC) injection in patients with ulcerative colitis
Acronym
VIVSC study
Scientific Title
Investigation of preference, clinical efficacy and trough concentration of vedolizumab by patient-oriented switching to intravenous (IV) or subcutaneous (SC) injection in patients with ulcerative colitis
Scientific Title:Acronym
VIVSC study
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Medicine in general | Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims of this study is to clarify the preference and clinical efficacy of vedolizumab by questionnaire survey and trough concentraion in patients with ulcerative colitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Selectivity of intraveous or subctaneous injection of vedolizumab
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with ulcerative coltis who treated or will be treated by vedolizumab
Key exclusion criteria
1. Patients who has allergy to vedolizumab
2. Patients who determined to be inappropriate for this study by physician
Target sample size
50
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
0492283564
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
3508550
Address
1981, Kamoda, Kawagoe City, Saitama, Japan
TEL
0492283564
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
0492283902
smcrinri@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
| 2024 | Year | 06 | Month | 07 | 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
| 2024 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Preference and satisfaction of vedolizumab treatment are investigated by questionnaire survey at baseline and 6 month later, as well as, at the timing of switching and 6 months later.
2. Clinical activity and inflammation markers are followed up during this study period.
3. Vedolizumab trough and anti-drug antibody are investigated at baseline and 6 month later, as well as, at the timing of switching and 6 months later.
Management information
Registered date
| 2024 | Year | 04 | Month | 07 | Day |
Last modified on
| 2024 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061757
