UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Current Status of the Effectiveness of Infliximab with Ulcerative colitis-A prospective observational study of serum Infliximab consentrations-
Title of the study (Brief title)	Current Status of the Effectiveness of Infliximab with Ulcerative colitis-A prospective observational study of serum Infliximab consentrations-
Region	Japan

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

Objectives
Narrative objectives1	We prospectively study treatment outcomes in patients who received infliximab, including measurement of serum infliximab concentrations and the titers of antibodies to infliximab.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	improvement rates 14 weeks after starting treatment with infliximab
Key secondary outcomes	improvement rates 14 and 54 weeks after starting treatment with infliximab serum infliximab concentrations and ATI rates at these times correlations of serum infliximab concentrations with disease severity and the treatment response mucosal healing rate at 54 weeks side effect

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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	ulcerative colitis active stage over 16 years old
Key exclusion criteria	Patients enrolled in other clinical trial pregnancy post operation of ulcerative colitis past history: cancer, malignancy serious infection tuberculosis allergy to medicine multiple sclerosis heart fairuler
Target sample size	20

Research contact person
Name of lead principal investigator	Kaoru Yokoyama
Organization	Kitasato University Hospital
Division name	Gastroenterology
Address	1-15-1Kitasato Minami-ku Sagamiara Japan
TEL	042-778-8111
Email	kaoru.y@kitasato-u.ac.jp

Public contact
Name of contact person	Kaoru Yokoyama
Organization	Kitasato University Hospital
Division name	Gastroenterology
Address	1-15-1Kitasato Minami-ku Sagamihara Japan
TEL	042-778-8111
Homepage URL
Email	kaoru.y@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University
Institute
Department

Funding Source
Organization	Self funding
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 02 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 31 Day
Anticipated trial start date	2013 Year 10 Month 31 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	prospective observational study ulcerative colitis cases who need Infliximab that adapted to criteria for selection case registration period: From 31 Oct 2013 to 31 March 2016. measurement items:complete blood count, clinical chemistry tests,serum infliximab concentrations, ATI, colonoscopy

Management information
Registered date	2017 Year 02 Month 05 Day
Last modified on	2017 Year 08 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029896