UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037953
Receipt number R000043263
Scientific Title Correlation between anti-infliximab trough level and clinical markers in ulcerative colitis patients treated with infliximab
Date of disclosure of the study information 2019/09/09
Last modified on 2023/03/10 18:32:03

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Basic information

Public title

Correlation between anti-infliximab trough level and clinical markers in ulcerative colitis patients treated with infliximab

Acronym

IFX trough level in UC patients

Scientific Title

Correlation between anti-infliximab trough level and clinical markers in ulcerative colitis patients treated with infliximab

Scientific Title:Acronym

IFX trough level in UC patients

Region

Japan


Condition

Condition

ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine the efficacy of measuring anti-infliximab trough levels.

Basic objectives2

Pharmacodynamics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

time for clinical and endoscopic recurrence

Key secondary outcomes

factors associated with anti-infliximab trough levels


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

ulcerative colitis patients treated with infliximab

Key exclusion criteria

patients with allergy to infliximab
patients with severe cardiovascular disease treated with anticoagulant medications
patients suspected colonic cancer
patinent with severe infectious disease through blood

Target sample size

22


Research contact person

Name of lead principal investigator

1st name Hiroki
Middle name
Last name Tanabe

Organization

Asahikawa general Kousei hospital

Division name

Department of gastroenterology

Zip code

078-8211

Address

1-Jo 24-chome, Asahikawa, Hokkaido, Japan

TEL

+81-166-33-7171

Email

tant@asahikawa-med.ac.jp


Public contact

Name of contact person

1st name Hiroki
Middle name
Last name Tanabe

Organization

Asahikawa Medical University

Division name

Department of Medicine

Zip code

078-8510

Address

Midorigaoka-Higashi 2-1-1-1, Asahikawa, Hokkaido

TEL

+81-166-68-2462

Homepage URL


Email

tant@asahikawa-med.ac.jp


Sponsor or person

Institute

Asahikawa Medical University

Institute

Department

Personal name



Funding Source

Organization

Asahikawa Medical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Asahikawa Kouse General Hospital ethical committee

Address

1-jo 24-chome, Asahikawa

Tel

+81-166-68-2297

Email

kotomi.hashimoto at ja-hokkaidoukouseiren.or.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

2019 Year 09 Month 09 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

18

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

Completed

Date of protocol fixation

2016 Year 08 Month 16 Day

Date of IRB

2017 Year 02 Month 07 Day

Anticipated trial start date

2017 Year 02 Month 07 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry

2022 Year 03 Month 31 Day

Date trial data considered complete

2022 Year 03 Month 31 Day

Date analysis concluded

2023 Year 03 Month 31 Day


Other

Other related information

Anti-TNF trough levels were measured from eligible patients and they were treated for 3 years, observed in clinical and endoscopic remission


Management information

Registered date

2019 Year 09 Month 06 Day

Last modified on

2023 Year 03 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043263


Research Plan
Registered date File name
2020/09/07 研究計画書・IFXトラフ値v2.2.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name