UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of a human interleukin 12/23 monoclonal antibody and investigation of expression of IL12/23p40 in Crohn disease anorectal lesion.
Title of the study (Brief title)	The efficacy of a human interleukin 12/23 monoclonal antibody and investigation of expression of IL12/23p40 in Crohn disease anorectal lesion.
Region	Japan

Condition
Condition	Crohn's disease
Classification by specialty	Gastroenterology Gastrointestinal surgery Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the efficacy of a human interleukin 12/23 monoclonal antibody on Crohn's disease anorectal lesion by the change in PDAI before and after treatment and the change in the expression level of cytokines including IL12 / 23p40, and to examine the relationship between efficacy and patient characteristics.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the efficacy of a human interleukin 12/23 monoclonal antibody in Crohn's disease anorectal lesion
Key secondary outcomes	A Blood cytokine expression status before and after administration of a human interleukin 12/23 monoclonal antibody

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	10 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who introduce a human interleukin 12/23 monoclonal antibody in Crohn's disease anal lesion
Key exclusion criteria	Age under 10 yrs. Patients without consent.
Target sample size	100

Research contact person
Name of lead principal investigator	Hiroki Ikeuchi
Organization	Hyogo College of Medicine
Division name	Department of Inflammatory Bowel Disease
Address	1-1 Mukogawacho, Nishinomiya, Hyogo, Japan
TEL	0798456371
Email	Ikeuci2s@hyo-med.ac.jp

Public contact
Name of contact person	Hiroki Ikeuchi
Organization	Hyogo College of Medicine
Division name	Department of Inflammatory Bowel Disease
Address	1-1 Mukogawacho, Nishinomiya, Hyogo, Japan
TEL	0798456371
Homepage URL
Email	Ikeuci2s@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Hyogo College of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 08 Month 21 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 08 Month 12 Day
Anticipated trial start date	2017 Year 08 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	PDAI is evaluated before administration of a human interleukin 12/23 monoclonal antibody and 6 weeks after administration, and cytokines including IL12 / 23p40 are quantified by ELISA.

Management information
Registered date	2017 Year 08 Month 21 Day
Last modified on	2019 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031806