UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prediction of therapeutic efficacy of infliximab for refractory ulcerative colitis by analyzing and measuring serum concentration of cytokines and infliximab
Title of the study (Brief title)	Prediction of therapeutic efficacy of IFX for refractory UC by measuring serum cytokines and IFX
Region	Japan

Condition
Condition	Ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To establish a biomarker to predict the therapeutic efficacy of infliximab for refractory ulcerative colitis.
Basic objectives2	Others
Basic objectives -Others	To search a predicting factor for the efficacy
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The correlation between the clinical and endoscopic efficacy of infliximab for ulcerative colitis and the serum concentration of IL-6, TNF-alpha and IFX.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with refractory ulcerative colitis who are candidates for infliximab therapy.
Key exclusion criteria	Patients who refuse the induction infliximab therapy or those who don't agree with participating in this study after sufficient written explanation.
Target sample size	100

Research contact person
Name of lead principal investigator	Tadakazu Hisamatsu
Organization	School of Medicine, Keio University
Division name	Division Gastroenterology and Hepatology, Department of Internal Medicine
Address	Shinanomachi 35, Shinjuku-ku, Tokyo
TEL	03-5363-3790
Email	hisamachi@a7.keio.jp

Public contact
Name of contact person	Tadakazu Hisamatsu
Organization	School of Medicine, Keio University
Division name	Division Gastroenterology and Hepatology, Department of Internal Medicine
Address	Shinanomachi 35, Shinjuku-ku, Tokyo
TEL	03-5363-3790
Homepage URL
Email	hisamachi@a7.keio.jp

Sponsor
Institute	School of Medicine, Keio University Division Gastroenterology and Hepatology, Department of Internal Medicine
Institute
Department

Funding Source
Organization	School of Medicine, Keio University Division Gastroenterology and Hepatology, Department of Internal 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	慶應義塾大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 03 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 04 Day
Anticipated trial start date	2013 Year 03 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2015 Year 03 Month 31 Day

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

Management information
Registered date	2013 Year 03 Month 10 Day
Last modified on	2018 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011951