UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory study of relation between efficacy and serum infliximab level, and predictors of response to infliximab dose escalation in patients with crohn's disease
Acronym	Exploratory study of relation between efficacy and serum infliximab level, and predictors of response to infliximab dose escalation in patients with crohn's disease
Scientific Title	Exploratory study of relation between efficacy and serum infliximab level, and predictors of response to infliximab dose escalation in patients with crohn's disease
Scientific Title:Acronym	Exploratory study of relation between efficacy and serum infliximab level, and predictors of response to infliximab dose escalation in patients with crohn's disease
Region	Japan

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

Objectives
Narrative objectives1	The aims of this study are to assess the relation between efficacy and serum infliximab level, and to find predictors of response to infliximab dose escalation in patients with crohn's disease.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between CDAI change and serum infliximab level from week 0 to week 16 and 40 in increased dose period
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	dose escalation of infliximab
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with active crohn's disease ( CDAI>= 150 and CRP >= 0.3mg/dL ) on 5mg/kg infliximab
Key exclusion criteria	1)Patients whose age below 18 years old 2)Patients with serious infection (sepsis,etc) 3)Patients with active tuberculosis 4)Patients with history of allergy to ingredients of infliximab or to proteins derived from mouse 5)Patients with demyelinating diseases and its past history 6)Patients with congestive heart failure 7)Patients who are inadequate to enter this trial due to the other reasons by physician's judgments
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Satoshi Motoya
Organization	Sapporo Kosei General Hospital
Division name	IBD Center
Zip code
Address	Kita-3, Higashi-8, Chuo-ku, Sapporo, HOKKAIDO, Japan
TEL	011-261-5331
Email	sa-motoya@nifty.com

Public contact
Name of contact person	1st name Middle name Last name Hiroki Tanaka
Organization	Sapporo Kosei General Hospital
Division name	IBD Center
Zip code
Address	Kita-3, Higashi-8, Chuo-ku, Sapporo, HOKKAIDO, Japan
TEL	011-261-5331
Homepage URL
Email	hirokit@mtc.biglobe.ne.jp

Sponsor
Institute	IBD Center, Sapporo Kosei General Hospital
Institute
Department

Funding Source
Organization	Department of Gastroenterology, Rheumatology and Clinical Immunology, Sapporo Medical University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2014 Year 07 Month 31 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
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	2014 Year 04 Month 22 Day
Date of IRB	2014 Year 08 Month 01 Day
Anticipated trial start date	2014 Year 08 Month 01 Day
Last follow-up date	2015 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 05 Month 20 Day
Last modified on	2022 Year 10 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016314