UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025429 |
|---|---|
| Receipt number | R000029173 |
| Scientific Title | Post-marketing surveillance for acute Kawasaki Disease under Remicade treatment |
| Date of disclosure of the study information | 2016/12/27 |
| Last modified on | 2020/01/07 14:59:13 |
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Basic information
Public title
Post-marketing surveillance for acute Kawasaki Disease under Remicade treatment
Acronym
SAKURA study
Scientific Title
Post-marketing surveillance for acute Kawasaki Disease under Remicade treatment
Scientific Title:Acronym
SAKURA study
Region
| Japan |
Condition
Condition
Acute Kawasaki disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The Specified Drug Use Survey is implemented to collect and evaluate information on the safety and efficacy of the Drug for pediatric patients with Kawasaki disease who are treated with the Drug under actual use conditions for the treatment of the disease.
After completion of assessments of safety and efficacy of the Drug, follow-up will also be conducted in the Survey for potential development of infections caused by administration of live vaccines in children.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defervescence rate within dosage 48 hours
Incidence of advers drug reactions
Key secondary outcomes
Change in defervescence rate
Duration of fever
Incidence of the coronary lesion
Overall improvement
Infections caused by administration of live vaccines
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with acute Kawasaki disease who receive the Drug (Limited to those having inadequate response to conventional therapy)
Key exclusion criteria
Patients with acute Kawasaki disease who meet "CONTRAINDICATIONS" to the use of the Drug
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Kubo |
Organization
Mitsubishi Tanabe Pharma Corporation
Division name
Ikuyaku Medical Researh Department
Zip code
541-8505
Address
3-2-10, Dosho-machi,Chuo-ku, Osaka 541-8505, Japan
TEL
06-6205-5362
kubo.hajime@mm.mt-pharma.co.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Sasaki |
Organization
Mitsubishi Tanabe Pharma Corporation
Division name
Pharmacovigilance Department
Zip code
541-8505
Address
3-16-89, Kashima, Yodogawa-ku, Osaka 532-8505, Japan
TEL
06-6300-2584
Homepage URL
sasaki.yoshifumi@mm.mt-pharma.co.jp
Sponsor or person
Institute
Mitsubishi Tanabe Pharma Corporation
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
None
Address
None
Tel
None
None
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 27 | Day |
Related information
URL releasing protocol
https://journals.lww.com/pidj/Fulltext/2020/01000/Real_world_Safety_and_Effectiveness_of_Infliximab
Publication of results
Partially published
Result
URL related to results and publications
https://journals.lww.com/pidj/Fulltext/2020/01000/Real_world_Safety_and_Effectiveness_of_Infliximab.
Number of participants that the trial has enrolled
291
Results
Please see:
https://journals.lww.com/pidj/Fulltext/2020/01000/Real_world_Safety_and_Effectiveness_of_Infliximab.8.aspx
Results date posted
| 2020 | Year | 01 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Please see:
https://journals.lww.com/pidj/Fulltext/2020/01000/Real_world_Safety_and_Effectiveness_of_Infliximab.8.aspx
Participant flow
Please see:
https://journals.lww.com/pidj/Fulltext/2020/01000/Real_world_Safety_and_Effectiveness_of_Infliximab.8.aspx
Adverse events
Please see:
https://journals.lww.com/pidj/Fulltext/2020/01000/Real_world_Safety_and_Effectiveness_of_Infliximab.8.aspx
Outcome measures
Please see:
https://journals.lww.com/pidj/Fulltext/2020/01000/Real_world_Safety_and_Effectiveness_of_Infliximab.8.aspx
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 28 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 28 | Day |
Other
Other related information
None
Management information
Registered date
| 2016 | Year | 12 | Month | 27 | Day |
Last modified on
| 2020 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029173
