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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000039947 |
Receipt No. | R000045550 |
Scientific Title | Follow-up of effectiveness in patients with inflammatory bowel diseases treated by ustekinumab and vedolizumab |
Date of disclosure of the study information | 2020/05/11 |
Last modified on | 2020/05/23 |
Basic information | ||
Public title | Follow-up of effectiveness in patients with inflammatory bowel diseases treated by ustekinumab and vedolizumab | |
Acronym | UV follow-up study in IBD | |
Scientific Title | Follow-up of effectiveness in patients with inflammatory bowel diseases treated by ustekinumab and vedolizumab | |
Scientific Title:Acronym | UV follow-up study in IBD | |
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 ustekinumab and vedolizumab-effects in prospective single-center observational study in IBD, such as ulcerative colitis and Crohn's disease patients |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Persistence of ustekinumab and vedolizumab at week 56 |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Active IBD patients who will be treated with ustekinumab and vedolizumab | |||
Key exclusion criteria | 1. Patients with severe infection
2. Patients with active tuberculosis 3. Patients who has allergy against ustekinumab and vedolizumab 4. Maternal patients and patients with breastfeeding 5. Patients who has malignancy and who has past history of malignancy 6. Patients who has ostomy 7. Patients determined to be inappropriate for this study |
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Target sample size | 80 |
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 | Enrolling by invitation | ||||||
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 UST and 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. |
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=R000045550 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |