UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011820
Receipt No. R000013783
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)
Date of disclosure of the study information 2013/10/01
Last modified on 2020/03/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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Narrative objectives1 Investigation that the rapid dose increase of IFX is effective to control of CD, and IFX can be withdrawn for good condition CD patients.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


Contact us.