UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024178 |
|---|---|
| Receipt number | 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 00:18:07 |
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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
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
asami_sherry@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University Hospital Department of Pediatrics
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027836
