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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Terminated |
Unique ID issued by UMIN | UMIN000039916 |
Receipt No. | R000045522 |
Scientific Title | Prospective evaluation of vedolizumab-effects in patients with inflammatory bowel diseases |
Date of disclosure of the study information | 2020/05/11 |
Last modified on | 2020/05/23 |
Basic information | ||
Public title | Prospective evaluation of vedolizumab-effects in patients with inflammatory bowel diseases | |
Acronym | VED IBD Cohort Study | |
Scientific Title | Prospective evaluation of vedolizumab-effects in patients with inflammatory bowel diseases | |
Scientific Title:Acronym | VED IBD Cohort Study | |
Region |
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Condition | |||
Condition | ulcerative colitis and Crohn's disease | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Evaluation of vedolizumab-effects in prospective single-center cohort of IBD patients |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Persistence of vedolizumab at week 54 |
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 | |
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Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients with inflammatory bowel diseases, such as ulcerative colitis and Crohn's disease treated with vedolizumab | |||
Key exclusion criteria | 1. Patients without informed consent
2. Patients determined to be inappropriate by doctor |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Saitama Medical Center, Saitama Medical University | ||||||
Division name | Department of Gastroenterology and Hepatology | ||||||
Zip code | 350-8550 | ||||||
Address | 1981 Kamoda, Kawagoe City, Saitama 3508550, Japan | ||||||
TEL | 049-228-3564 | ||||||
skato@saitama-med.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Saitama Medical Center, Saitama Medical University | ||||||
Division name | Department of Gastroenterology and Hepatology | ||||||
Zip code | 350-8550 | ||||||
Address | 1981 Kamoda, Kawagoe City, Saitama 3508550, Japan | ||||||
TEL | 049-228-3564 | ||||||
Homepage URL | |||||||
skato@saitama-med.ac.jp |
Sponsor | |
Institute | Saitama Medical Center, Saitama Medical University |
Institute | |
Department |
Funding Source | |
Organization | Saitama Medical Center, Saitama Medical University |
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 Saitama Medical Center |
Address | 1981 Kamoda, Kawagoe City, Saitama 3508550, Japan |
Tel | 049-228-3902 |
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 |
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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 | Terminated | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | Decision of VED is determined by doctor in clinical practice. All patients determined to be treated by VED were able to be enrolled in this study regardless of their clinical activities or history of treatment after the acquisition of informed consent. Shortening of vedolizumab treatment ever 4 weeks were not permitted in Japan.
The name of this study was determined not to be appropriate by the IRB in Saitama Medical Center and was re-registered as UMIN000040175. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045522 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |