UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001250 |
|---|---|
| Receipt number | 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 08:50:23 |
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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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001523
