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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000025429
Receipt No. 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

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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
Email 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
Email sasaki.yoshifumi@mm.mt-pharma.co.jp

Sponsor
Institute Mitsubishi Tanabe Pharma Corporation
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029173

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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