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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007423
Receipt No. R000008739
Scientific Title Infliximab(anti human TNF alfa monoclonal antibody, Remicade) off-label treatment for refractory Kawasaki disease
Date of disclosure of the study information 2012/03/01
Last modified on 2016/03/01

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Basic information
Public title Infliximab(anti human TNF alfa monoclonal antibody, Remicade) off-label treatment for refractory Kawasaki disease
Acronym Infliximab treatment for refractory Kawasaki Disease
Scientific Title Infliximab(anti human TNF alfa monoclonal antibody, Remicade) off-label treatment for refractory Kawasaki disease
Scientific Title:Acronym Infliximab treatment for refractory Kawasaki Disease
Region
Japan

Condition
Condition Kawasaki disease
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test the efficacy of infliximab for refractory Kawasaki disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Coronary artery abnormality after infliximab treatment
Key secondary outcomes duration of fever

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 infliximab treatment
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
0 years-old <=
Age-upper limit
18 years-old >=
Gender Male and Female
Key inclusion criteria Patients with Kawasaki disease who do not respond to 2 cycles of high-dose gamma globulin and steroid pulse therapy, who do not respond to single cycle of high-dose gamma globulin with steroid and steroid pulse therapy, or who do not respond to 2 cycles of high-dose gamma globulin with steroid
Key exclusion criteria congestive heart failure, severe infection, active tuberculosis, hypersensitivity for mouse-derived protein, demyelinating decease
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Tamura
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Pediatrics
Zip code
Address Kamoda 1981, Kawagoe, Saitama, Japan
TEL 049-228-3617
Email mstamura@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Moriwaki
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Pediatrics
Zip code
Address Kamoda 1981, Kawagoe, Saitama, Japan
TEL 049-228-3617
Homepage URL
Email kmoriwa@saitama-med.ac.jp

Sponsor
Institute Department of Pediatrics, Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization Department of Pediatrics, Saitama Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization Self funding
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 埼玉医科大学総合医療センター(埼玉県)

Other administrative information
Date of disclosure of the study information
2012 Year 03 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 Completed
Date of protocol fixation
2012 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
2016 Year 02 Month 29 Day
Date of closure to data entry
2016 Year 02 Month 29 Day
Date trial data considered complete
2016 Year 02 Month 29 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 03 Month 01 Day
Last modified on
2016 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008739

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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