UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007423 |
|---|---|
| Receipt number | 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 14:00:55 |
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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
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
kmoriwa@saitama-med.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
