UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014670 |
|---|---|
| Receipt number | R000010379 |
| Scientific Title | The effect of Tocilizumab on synovitis of rheumatoid arthritis. Analysis by musculoskeletal ultrasonography |
| Date of disclosure of the study information | 2014/07/28 |
| Last modified on | 2014/07/28 09:49:28 |
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Basic information
Public title
The effect of Tocilizumab on synovitis of rheumatoid arthritis. Analysis by musculoskeletal ultrasonography
Acronym
The effect of Tocilizumab on synovitis of rheumatoid arthritis
Scientific Title
The effect of Tocilizumab on synovitis of rheumatoid arthritis. Analysis by musculoskeletal ultrasonography
Scientific Title:Acronym
The effect of Tocilizumab on synovitis of rheumatoid arthritis
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
analysis of the effect of tocilizumab on synovitis by using ultrasonography
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The ratio of MKUS remission joint at 52 weeks after TCZ treatment
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Eligible patients
1) are fulfilled ACR/EULAR criteria for the classification of RA.
2)have inadequate response to at least one anti rheumatic drug
3) are diagnosed to have indication for Tocilizumab treatment.
All patient should give written informed consent.
Key exclusion criteria
Exclusion patients
1) have serious infectious disease.
2) have active tuberculosis
3) have past history of hypersensitivity to Tocilizumab
4) are judged as inadequate to tocilizumab treatment by attending doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Morinobu |
Organization
Kobe University Hospital
Division name
Rheumatology and Clinical Immunology
Zip code
Address
7-5-2 Kusunoki-cho, Chuou-Ku, Kobe, Hyogo, Japan
TEL
078-382-6197
morinobu@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Goichi Kageyama |
Organization
Kobe University Hospital
Division name
Rheumatology and Clinical Immunology
Zip code
Address
7-5-2 Kusunoki-cho, Chuou-Ku, Kobe, Hyogo, Japan
TEL
078-382-5111
Homepage URL
kageyama@med.kobe-u.ac.jp
Sponsor or person
Institute
Department of Rheumatology and Clinical Immunology, Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Other
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
神戸大学付属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | 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
| 2012 | Year | 08 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluation of synovitis after TCZ administration by US
Management information
Registered date
| 2014 | Year | 07 | Month | 28 | Day |
Last modified on
| 2014 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010379
