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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024178
Receipt No. R000027836
Scientific Title Efficacy and safety of combination therapy of tocilizumab and abatacept in patients with refractory systemic-onset juvenile idiopathic arthritis
Date of disclosure of the study information 2016/09/28
Last modified on 2016/09/27

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Basic information
Public title Efficacy and safety of combination therapy of tocilizumab and abatacept in patients with refractory systemic-onset juvenile idiopathic arthritis
Acronym Efficacy and safety of combination therapy of tocilizumab and abatacept in patients with refractory systemic-onset juvenile idiopathic arthritis
Scientific Title Efficacy and safety of combination therapy of tocilizumab and abatacept in patients with refractory systemic-onset juvenile idiopathic arthritis
Scientific Title:Acronym Efficacy and safety of combination therapy of tocilizumab and abatacept in patients with refractory systemic-onset juvenile idiopathic arthritis
Region
Japan

Condition
Condition Systemic-onset juvenile idiopathic arthritis(sJIA)
Classification by specialty
Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of combination therapy of tocilizumab and abatacept in patients with refractory systemic-onset juvenile idiopathic arthritis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ACR pedi30 at week 24
Key secondary outcomes Safety
dose of corticosteroids
biomarkers of disease activity(MMP-3, IL-6, and IL18)
ultrasonography

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Tocilizumab 8mg/kg every 2 weeks, and Abatacept 10 mg/kg every 4 weeks
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
2 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1 Patients with a diagnosis of sJIA at childhood and with refractory arthritis
2 Patients gave written informed consent
Key exclusion criteria 1 Pulmonary tuberculosis, active bacterial infection or deep mycotic infection
2 Infection of HIV, HCV, HBV
3 Administration of live vaccine within 4 weeks
4 Cardiac dysfunction
5 Pregnant subjects or subjects who do not agree with contraception during the study period
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Asami Oohara
Organization Yokohama City University Hospital
Division name Pediatrics
Zip code
Address Fukuura 3-9, Kanazawa-ku, Yokohama city, Kanagawa 236-0004, Japan
TEL 045-787-2800
Email asami_sherry@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Asami Oohara
Organization Yokohama City University Hospital
Division name Pediatrics
Zip code
Address Fukuura 3-9, Kanazawa-ku, Yokohama city, Kanagawa 236-0004, Japan
TEL 045-787-2800
Homepage URL
Email asami_sherry@yahoo.co.jp

Sponsor
Institute Yokohama City University Hospital Department of Pediatrics
Institute
Department

Funding Source
Organization self funding
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

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 28 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 Open public recruiting
Date of protocol fixation
2016 Year 08 Month 03 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 27 Day
Last modified on
2016 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027836

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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