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Investigation that the rapid dose increase of IFX is effective to control of CD, and IFX can be withdrawn for good condition CD patients.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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name