UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of allergic reaction during the treatment of anti-TNF alpha monoclonal antibody in patients with inflammatory bowel diseases
Title of the study (Brief title)	Investigation of allergic reaction in anti-TNF alpha monoconal antibody- treatment
Region	Japan

Condition
Condition	inflammatory boewl diseases
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of prognostic biomarker for detection of allergic reaction of anti-TNF alpha monoclonal antibody
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Investigation of biomarker
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine Other
Interventions/Control_1	Allergic group for anti-TNF aplha monoclonal antibody
Interventions/Control_2	non allergic group for anti-TNF aplha monoclonal antibody
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	IBD patients who had or will have a informed consent of clinical study of UMIN000005032
Key exclusion criteria	Patients without informed consent
Target sample size	60

Research contact person
Name of lead principal investigator	Shingo Kato
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Gastroenterology and Hepatology
Address	1981 Kamoda, Kawagoe, Saitama 350-8550, Japan
TEL	049-228-3564
Email	skato@saitama-med.ac.jp

Public contact
Name of contact person	Shingo Kato
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Gastroenterology and Hepatology
Address	1981 Kamoda, Kawagoe, Saitama 350-8550, Japan
TEL	049-228-3564
Homepage URL
Email	skato@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization	Saitama Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization	Other
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	2013 Year 05 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 01 Day
Anticipated trial start date	2013 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 03 Month 31 Day

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

Management information
Registered date	2013 Year 04 Month 16 Day
Last modified on	2018 Year 01 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012291