UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028139
Receipt number R000032210
Scientific Title Therapeutic reactivity of Ustekinumab in moderate to severe active stage Crohn's disease
Date of disclosure of the study information 2017/07/07
Last modified on 2022/01/31 16:32:01

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Basic information

Public title

Therapeutic reactivity of Ustekinumab in moderate to severe active stage Crohn's disease

Acronym

Therapeutic reactivity of Ustekinumab in moderate to severe active stage Crohn's disease

Scientific Title

Therapeutic reactivity of Ustekinumab in moderate to severe active stage Crohn's disease

Scientific Title:Acronym

Therapeutic reactivity of Ustekinumab in moderate to severe active stage Crohn's disease

Region

Japan


Condition

Condition

Crohn's disease

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aimed to evaluate the therapeutic effciency of Ustekinumab for Crohn's disease resistant to conventional treatment

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of the number of Ustekinumab bound cells in biopsy tissue and blood cells

Key secondary outcomes

Remission induction rate, drug efficacy rate, remission maintenance rate and duration, endoscopic improvement rate, side effect occurrence rate, biomarker such as CRP, changes in intestinal flora before and after administration of Ustekinumab, various inflammatory properties in blood and tissues Changes in cytokines


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Treatment with 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


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients with moderate to severe active phase Crohn's disease who are resistant to conventional treatment, or patients requiring the introduction of Ustekinumab after Crohn's disease surgery.
2) Patients who aged 20 years or older.
3) Patients who wanted treatment by Ustekinumab, and obtained written consent.

Key exclusion criteria

1) Patients with serious infection.
2) Patients with active tuberculosis.
3) Patients whose dosage of steroids is not stable (patients over 30 mg / day)
4) Patients with severe heart disease, liver disease, kidney disease.
5) Patients with marked blood coagulation disorders and thrombocytopenia.
6) Antithrombotic drugs Patients who are taking internal medicine and patients under anticoagulation therapy.
7) Pregnant women or patients who may be pregnant, breast-feeding patients.
8) Patients who are judged to be difficult to participate in the examination due to psychosis or psychiatric symptoms.
9) Patients with short bowel syndrome.
10) Patients who are judged inappropriate by the attending physician, such as a decline in compliance.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Takanari
Middle name /
Last name Kitazono

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Department of Medicine and Clinical Science

Zip code

812-8582

Address

Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan

TEL

0926425261

Email

kitazono@intmed2.med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name Yutaro
Middle name /
Last name Ihara

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Department of Medicine and Clinical Science

Zip code

8128582

Address

Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University,

TEL

0926425261

Homepage URL


Email

yihara@intmed2.med.kyushu-u.ac.jp


Sponsor or person

Institute

Graduate School of Medical Sciences, Kyushu University

Institute

Department

Personal name



Funding Source

Organization

Graduate School of Medical Sciences, Kyushu 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

KYUSHU UNIVERSITY Center for Clinical and Translational Research(CCTR)

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, JAPAN

Tel

0926425774

Email

ijkseimei@jimu.kyushu-u.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

2017 Year 07 Month 07 Day


Related information

URL releasing protocol

https://www.karger.com/Article/Abstract/518103

Publication of results

Published


Result

URL related to results and publications

https://www.karger.com/Article/Abstract/518103

Number of participants that the trial has enrolled

27

Results

The frequency of T helper 17 (Th17) cells was significantly decreased in the peripheral blood of patients with active CD after UST therapy, but not in the anti-TNF therapy. In addition, the changes in gene expression before and after UST and anti-TNF therapy were clearly different. From the above results, it was shown that the suppression of Th17 differentiation by UST therapy is associated with the anti-inflammatory effect on CD.

Results date posted

2022 Year 01 Month 31 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 11 Month 01 Day

Baseline Characteristics

The CD patients were limited to active patients with a CDAI150 points or higher, C-reactive protein (CRP) level 0.3 mg/dl or higher, or simple endoscopic score for CD (SES-CD) 3 points or higher.

Participant flow

We prospectively followed patients who underwent induction therapy for active phase CD from June 2017 to March 2020. We collected clinical information, blood samples, and colonic mucosal tissues.

Adverse events

none

Outcome measures

The changes in the proportions of T cell subsets after these therapies were analyzed by flow cytometry. Comprehensive gene expression changes in the colonic mucosa were also evaluated.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 07 Month 04 Day

Date of IRB

2017 Year 07 Month 04 Day

Anticipated trial start date

2017 Year 07 Month 04 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2020 Year 03 Month 31 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 07 Month 07 Day

Last modified on

2022 Year 01 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032210


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name