UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039947
Receipt number 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 13:55:02

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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

Japan


Condition

Condition

ulcerative colitis and Crohn's disease

Classification by specialty

Medicine in general Gastroenterology

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

18 years-old <=

Age-upper limit

80 years-old >=

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

Target sample size

80


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 3508550, Japan

TEL

049-228-3564

Email

skato@saitama-med.ac.jp


Public contact

Name of contact person

1st name Shingo
Middle name kato
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 3508550, Japan

TEL

049-228-3564

Homepage URL


Email

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

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

Email

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

2020 Year 05 Month 11 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

2020 Year 05 Month 07 Day

Date of IRB

2020 Year 05 Month 14 Day

Anticipated trial start date

2020 Year 05 Month 18 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

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

2020 Year 03 Month 26 Day

Last modified on

2020 Year 05 Month 23 Day



Link to view the page

Value
https://center6.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