UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011820 |
|---|---|
| Receipt number | 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 | 2023/03/29 09:34:44 |
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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Investigation that the rapid dose increase of IFX is effective to control of CD, and IFX can be withdrawn for good condition CD patients.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
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
toyotatu@kmail.plala.or.jp
Sponsor or person
Institute
NationalOrganizationHospital Fukuyama medical center
Institute
Department
Personal name
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
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
under analysis
Publication of results
Unpublished
Result
URL related to results and publications
under analysis
Number of participants that the trial has enrolled
15
Results
under analysis
Results date posted
| 2023 | Year | 03 | Month | 29 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
under analysis
Date of the first journal publication of results
Baseline Characteristics
under analysis
Participant flow
under analysis
Adverse events
under analysis
Outcome measures
under analysis
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
| 2012 | Year | 12 | Month | 01 | Day |
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
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 20 | Day |
Last modified on
| 2023 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013783
