UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of method for prediction of therapeutic effect of infliximab initial therapy for inflammatory bowel disease
Acronym	IPININ study
Scientific Title	Investigation of method for prediction of therapeutic effect of infliximab initial therapy for inflammatory bowel disease
Scientific Title:Acronym	IPININ study
Region	Japan

Condition
Condition	Ulcerative colitis, Crohn's disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We have investigated whether trough level of infliximab predicts future outcomes of induction therapy.
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary end point was prediction of a clinical response at week 22.
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	13 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with IBD who admitted to ofuna chuo hospital for induction therapy of Infliximab. Patients who gave written informed consent for this study
Key exclusion criteria	Patients who are considered not suitable for Infliximab use due to contraindication or considerable risks such as hypersensitivity to Infliximab. Other than above mentioned criteria, patients who are judged inappropriate by the doctor.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Atsushi Yoshida
Organization	Ofuna Chuo Hospital
Division name	Center for Gastroenterology and Inflammatory Bowel Disease
Zip code
Address	Ofuna 6-2-24, Kamakura, Japan
TEL	+81-46-745-2111
Email	atushi.y@kza.biglobe.ne.jp

Public contact
Name of contact person	1st name Middle name Last name Atsushi Yoshida
Organization	Ofuna Chuo Hospital
Division name	Center for Gastroenterology and Inflammatory Bowel Disease
Zip code
Address	Ofuna 6-2-24, Kamakura, Japan
TEL	+81-46-745-2111
Homepage URL
Email	atushi.y@kza.biglobe.ne.jp

Sponsor
Institute	Ofuna Chuo Hospital
Institute
Department

Funding Source
Organization	none
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
Address
Tel
Email

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	2016 Year 06 Month 14 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications	https://www.sciencedirect.com/science/article/abs/pii/S0928098720301068
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	Main results already published
Date of protocol fixation	2016 Year 04 Month 04 Day
Date of IRB	2016 Year 04 Month 04 Day
Anticipated trial start date	2016 Year 04 Month 04 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We have investigated whether trough level of infliximab predicts future outcomes of induction therapy using PK/PD model.

Management information
Registered date	2016 Year 06 Month 13 Day
Last modified on	2022 Year 10 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026177