UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of tight control of Infliximab (IFX) for Crohn's disease (CD) by CRP value and fecal concentration of calprotectin (Quattro C study)
Acronym	Investigation of efficacy of tight control or withdrawal of Infliximab (IFX) for Crohn's disease (CD) by CRP value and fecal concentration of calprotectin
Scientific Title	Efficacy of tight control of Infliximab (IFX) for Crohn's disease (CD) by CRP value and fecal concentration of calprotectin (Quattro C study)
Scientific Title:Acronym	Investigation of efficacy of tight control or withdrawal of Infliximab (IFX) for Crohn's disease (CD) by CRP value and fecal concentration of calprotectin
Region	Japan

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

Objectives
Narrative objectives1	Investigation that the rapid dose increase of IFX is effective to control of CD, and IFX can be withdrawn for good condition CD patients. Elucidate of evaluating disease condition by CRP value and fecal concentration of calprotectin
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Clinical remission rate after 104 weeks (Interim analysis performed in 52 weeks)
Key secondary outcomes	Correlation with change of IFX dose and CRP value or fecal concentration of calprotectin

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Withdrawal of IFX for patients with clinical remission and negative of CRP value
Interventions/Control_2	Resume or dose increase of IFX for patients with consecutive positive of CRP value or fecal concentration of calprotectin
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 receiving IFX more than 3 times previously
Key exclusion criteria	Patients receiving IFX with 10 mg/kg dose Patients receiving IFX at interval of less than 6 weeks
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Tatsuya Middle name Last name Toyokawa
Organization	NationalOrganizationHospital Fukuyama medical center
Division name	Department of Gastroenterology
Zip code	720-8520
Address	4-14-17 Okinogami-cho,Fukuyama-city,Hiroshima
TEL	084-922-0001
Email	toyotatu@kmail.plala.or.jp

Public contact
Name of contact person	1st name Tatsuya Middle name Last name Toyokawa
Organization	NationalOrganizationHospital Fukuyama medical center
Division name	Department of Gastroenterology
Zip code	720-8520
Address	4-14-17 Okinogami-cho,Fukuyama-city,Hiroshima
TEL	084-922-0001
Homepage URL
Email	toyotatu@kmail.plala.or.jp

Sponsor
Institute	NationalOrganizationHospital Fukuyama medical center
Institute
Department

Funding Source
Organization	NationalOrganizationHospital Fukuyama medical center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor	None
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization	National Hospital Organization Fukuyama Medical Center
Address	4-14-17, Okinogami-cho, Fukuyama city
Tel	084-922-0001
Email	toyotatu@kmail.plala.or.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	国立病院機構福山医療センター（広島県）

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 01 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	Open public recruiting
Date of protocol fixation	2013 Year 04 Month 11 Day
Date of IRB
Anticipated trial start date	2013 Year 05 Month 01 Day
Last follow-up date	2018 Year 06 Month 30 Day
Date of closure to data entry	2018 Year 06 Month 30 Day
Date trial data considered complete	2018 Year 06 Month 30 Day
Date analysis concluded	2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2013 Year 09 Month 20 Day
Last modified on	2020 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013783

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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