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

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 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


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

Value
https://center6.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