UMIN-CTR Clinical Trial

Basic information
Public title	Current Status of the Effectiveness of Infliximab with Crohn's disease-A prospective observational study of serum Infliximab consentrations-
Acronym	Current Status of the Effectiveness of Infliximab with Crohn's disease-A prospective observational study of serum Infliximab consentrations-
Scientific Title	Current Status of the Effectiveness of Infliximab with Crohn's disease-A prospective observational study of serum Infliximab consentrations-
Scientific Title:Acronym	Current Status of the Effectiveness of Infliximab with Crohn's disease-A prospective observational study of serum Infliximab consentrations-
Region	Japan

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

Objectives
Narrative objectives1	We prospectively study treatment outcomes in Crohn's disease patients who received infliximab, including measurement of serum infliximab concentrations and the titers of antibodies to infliximab for 2 years.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	improvement rates 54 weeks after starting treatment with infliximab
Key secondary outcomes	remission and improvement rates 14, 54 and 102 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 The rate of continuing treatment with infliximab 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	Crohn's disease active stage in Kitasato University Hospital over 16 years old
Key exclusion criteria	Patients enrolled in other clinical trial pregnancy 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	1st name Kaoru Middle name Last name Yokoyama
Organization	Kitasato University School of Medicine
Division name	Gastroenterology
Zip code	252-0374
Address	1-15-1 Kitasato Minami, Sagamihara Kanagawa
TEL	042-778-8111
Email	kaoru.y@kitasato-u.ac.jp

Public contact
Name of contact person	1st name Kaoru Middle name Last name Yokoyama
Organization	Kitasato University School of Medicine
Division name	Gastroenterology
Zip code	252-0374
Address	1-15-1 Kitasato Minami, Sagamihara Kanagawa
TEL	042-778-8111
Homepage URL
Email	kaoru.y@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University School of Medicine
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)

IRB Contact (For public release)
Organization	1-15-1 Kitasato Minami, Sagamihara Kanagawa
Address	1-15-1 Kitasato Minami, Sagamihara Kanagawa
Tel	042-778-8111
Email	rinri@med.kitasato-u.ac.jp

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	北里大学病院

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 23 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	12
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	Completed
Date of protocol fixation	2013 Year 10 Month 31 Day
Date of IRB	2013 Year 10 Month 31 Day
Anticipated trial start date	2013 Year 12 Month 27 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 04 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	prospective observational study Crohn's disease cases who need Infliximab that adapted to criteria for selection case registration period: From 27 Dec 2013 to 31 Dec 2016. measurement items:complete blood count, clinical chemistry tests,serum infliximab concentrations, ATI

Management information
Registered date	2017 Year 07 Month 23 Day
Last modified on	2020 Year 01 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032440