UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of strategy for secondary failure of infliximab maintenance therapy to measure anti-infliximab antibody levels in patients with inflammatory bowel disease.
Title of the study (Brief title)	IFXATIIBD
Region	Japan

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

Objectives
Narrative objectives1	While anti-TNF-alpha antibody preparation (infliximab (Remicade), adalimumab (Humira)) is given in patients with inflammatory bowel disease, we do the drug treatment preferences criteria in the second case that became invalid if clear.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Two kinds evade that the second becomes invalid together early by doing the criteria for selection of anti-TNF-alpha antibody preparation having only two kinds if clear, and symptom exacerbation prevention of patients is enabled now.
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	15 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	It is the patient receiving anti-TNF-alpha antibody preparation (infliximab (Remicade), adalimumab (Humira)) among patients with ulcerative colitis, bowel type Behcet's disease and Crohn's disease.
Key exclusion criteria	The patients that it was not obtained consent after explanation.
Target sample size	150

Research contact person
Name of lead principal investigator	Hirotsugu Imaeda
Organization	Shiga University of Medical Science
Division name	Division of Gastroenterology, Department of Medicine
Address	Setatsukinowa, Otsu
TEL	0775482217
Email	imaeda@belle.shiga-med.ac.jp

Public contact
Name of contact person	Hirotsugu Imaeda
Organization	Shiga University of Medical Science
Division name	Division of Gastroenterology, Department of Medicine
Address	Setatsukinowa, Otsu
TEL	0775482217
Homepage URL
Email	imaeda@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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 02 Month 17 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 02 Month 16 Day
Anticipated trial start date	2017 Year 02 Month 16 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	2022 Year 04 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Study continuous

Management information
Registered date	2017 Year 02 Month 16 Day
Last modified on	2018 Year 08 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030075