UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of combination therapy of tocilizumab and abatacept in patients with refractory systemic-onset juvenile idiopathic arthritis
Title of the study (Brief title)	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	Asami Oohara
Organization	Yokohama City University Hospital
Division name	Pediatrics
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	Asami Oohara
Organization	Yokohama City University Hospital
Division name	Pediatrics
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 08 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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