UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001457
Receipt number R000001767
Scientific Title The efficacy evaluation of tocilizumab to glucocorticoid-resistant patients with adult Still's disease and systemic juvenile idiopathic arthritis: the open trial
Date of disclosure of the study information 2008/10/28
Last modified on 2014/04/28 12:06:10

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Basic information

Public title

The efficacy evaluation of tocilizumab to glucocorticoid-resistant patients with adult Still's disease and systemic juvenile idiopathic arthritis: the open trial

Acronym

Efficacy assessment of tocilizumab to steroid-resistant patients with adult Still's disease

Scientific Title

The efficacy evaluation of tocilizumab to glucocorticoid-resistant patients with adult Still's disease and systemic juvenile idiopathic arthritis: the open trial

Scientific Title:Acronym

Efficacy assessment of tocilizumab to steroid-resistant patients with adult Still's disease

Region

Japan


Condition

Condition

Adult Still's disease and systemic juvenile idiopathic arthritis

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of tocilizumab to patients with steroid-refractory adult Still's disease or juvenile idiopathic arthritis

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Amount of glucocorticoid-dose tapered after tocilizumab-administration

Key secondary outcomes



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 is to be infused every 2 to 4 weeks at 8 mg/kg of body weight

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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with steroid-resistant adult Still's disease or systemic juvenile idiopathic arthritis who are 18 years or older are to be enrolled.

Key exclusion criteria

1.pregnant women or women trying to get pregnant
2.patients with dementia
3.patients considered inappropriate judged by attending physicians

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahiro Iwamoto

Organization

Jichi Medical University

Division name

Division of Rheumatology & Clinical Immunology

Zip code


Address

3311-1 Yakushiji, Shimotsuke, Tochigi

TEL

0285587358

Email

hiro-iwa@jichi.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masahiro Iwamoto

Organization

Jichi Medical University

Division name

Division of Rheumatology & Clinical Immunology

Zip code


Address

3311-1 Yakushiji, Shimotsuke, Tochigi

TEL

0285587358

Homepage URL


Email

hiro-iwa@jichi.ac.jp


Sponsor or person

Institute

Division of Rheumatology & Clinical Immunology, Jichi Medical University

Institute

Department

Personal name



Funding Source

Organization

None

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

2008 Year 10 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

no recruitment

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

Terminated

Date of protocol fixation

2008 Year 06 Month 30 Day

Date of IRB


Anticipated trial start date

2008 Year 10 Month 01 Day

Last follow-up date

2013 Year 03 Month 01 Day

Date of closure to data entry

2013 Year 03 Month 31 Day

Date trial data considered complete

2013 Year 03 Month 31 Day

Date analysis concluded

2013 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2008 Year 10 Month 28 Day

Last modified on

2014 Year 04 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001767


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name