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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001250
Receipt No. R000001523
Scientific Title Study on the glucocorticoid-sparing effects of tocilizumab among glucocorticoid-dependent patients with adult Still's disease and systemic juvenile idiopathic arthritis: the open trial
Date of disclosure of the study information 2008/07/16
Last modified on 2013/07/16

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Basic information
Public title Study on the glucocorticoid-sparing effects of tocilizumab among glucocorticoid-dependent patients with adult Still's disease and systemic juvenile idiopathic arthritis: the open trial
Acronym Effects of tocilizumab-addition to steroid-dependent patients with adult Still's disease
Scientific Title Study on the glucocorticoid-sparing effects of tocilizumab among glucocorticoid-dependent patients with adult Still's disease and systemic juvenile idiopathic arthritis: the open trial
Scientific Title:Acronym Effects of tocilizumab-addition to steroid-dependent patients with adult Still's disease
Region
Japan

Condition
Condition Adult Still's disease or systemic juvenile idiopathic arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the steroid-reducing capability of tocilizumab in patients with steroid-dependent adult Still's disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amount of glucocorticoid-dose tapered after tocilizumab-addition
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 (8 mg/kg of body weight) is to be infused every 2 to 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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with steroid-dependent adult Still's disease or systemic juvenile idiopathic arthritis 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
Email

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
TEL
Homepage URL
Email hiro-iwa@jichi.ac.jp

Sponsor
Institute Division of Rheumatology & Clinical Immunology, Jichi Medical University
Institute
Department

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 07 Month 16 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2008 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2008 Year 07 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
2013 Year 04 Month 01 Day
Date trial data considered complete
2013 Year 09 Month 30 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 07 Month 15 Day
Last modified on
2013 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001523

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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