UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046650
Receipt number R000053213
Scientific Title exploratory study of optimizing ustekinumab dosing interval in ulcerative colitis
Date of disclosure of the study information 2022/01/18
Last modified on 2022/01/16 09:57:20

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Basic information

Public title

exploratory study of optimizing ustekinumab dosing interval in ulcerative colitis

Acronym

exploratory study of optimizing ustekinumab dosing interval in ulcerative colitis

Scientific Title

exploratory study of optimizing ustekinumab dosing interval in ulcerative colitis

Scientific Title:Acronym

exploratory study of optimizing ustekinumab dosing interval in ulcerative colitis

Region

Japan


Condition

Condition

ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate whether endoscopic mucosal healing can be used to determine the optimization of ustekinumab dosing intervals in patients with ulcerative colitis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

endoscopic therapeutic effects and clinical findings after UST administration at week 28 to 32.

Key secondary outcomes

Lichtiger index, white blood cells, platelets, albumin, C-reactive protein, erythrocyte sedimentation rate


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Endoscopy was performed 28 to 32 weeks after the administration of ustekinumab

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

20 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Patients aged 20 years or older at the time of obtaining the consent form.
2. Patients with ulcerative colitis who received ustekinumab.
3. Ulcers that have already started treatment with ustekinumab but have not undergone endoscopy after treatment within 24 weeks

Key exclusion criteria

1.Patients judged by the principal investigator to be inappropriate as subjects
2.Patients without discernment
3.Patients who cannot obtain written consent

Target sample size

30


Research contact person

Name of lead principal investigator

1st name YUKA
Middle name
Last name FUKUO

Organization

JUNTENDO UNIVERSITY NERIMA HOSPITAL

Division name

Gastroenterology

Zip code

1778521

Address

3-1-10 Takanodai Nerima-ku Tokyo

TEL

03-5923-3111

Email

yfukuo@juntendo.ac.jp


Public contact

Name of contact person

1st name YUKA
Middle name
Last name FUKUO

Organization

JUNTENDO UNIVERSITY NERIMA HOSPITAL

Division name

Gastroenterology

Zip code

1778521

Address

3-1-10 Takanodai Nerima-ku Tokyo

TEL

03-5923-3111

Homepage URL


Email

yfukuo@juntendo.ac.jp


Sponsor or person

Institute

JUNTENDO UNIVERSITY NERIMA HOSPITAL

Institute

Department

Personal name



Funding Source

Organization

nothing

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

JUNTENDO UNIVERSITY NERIMA HOSPITAL

Address

3-1-10 Takanodai Nerima-ku Tokyo

Tel

0359233111

Email

yfukuo@juntendo.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

2022 Year 01 Month 18 Day


Related information

URL releasing protocol


Publication of results

Partially published


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 10 Month 08 Day

Date of IRB

2020 Year 10 Month 08 Day

Anticipated trial start date

2020 Year 10 Month 08 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



Management information

Registered date

2022 Year 01 Month 16 Day

Last modified on

2022 Year 01 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053213


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name