UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012524 |
|---|---|
| Receipt number | R000014657 |
| Scientific Title | Assessment of therapeutic responsiviveness by imaging of the joints in patients with rheumatoid arthritis;A observational cohort study |
| Date of disclosure of the study information | 2013/12/09 |
| Last modified on | 2016/07/05 16:02:30 |
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Basic information
Public title
Assessment of therapeutic responsiviveness by imaging of the joints in patients with rheumatoid arthritis;A observational cohort study
Acronym
Assessment of therapeutic responsiveness by imaging in patients with rheumatoid arthritis
Scientific Title
Assessment of therapeutic responsiviveness by imaging of the joints in patients with rheumatoid arthritis;A observational cohort study
Scientific Title:Acronym
Assessment of therapeutic responsiveness by imaging in patients with rheumatoid arthritis
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the associations between clinical courses, imaging assessments such as plain radiograph, ultrasound, and magnetic resonance imaging, and biomarkers in rheumatoid arthritis treated with anti-rheumatic drugs.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of abnormalities of imaging at 52 week after introduction of anti-rheumatic drugs
Key secondary outcomes
Association of improvement of clinical indices, biomarkers and image findings.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
RA patient by whom the consent to this research was got while going to hospital regularly to this department (under visitors and hospitalization)
Key exclusion criteria
Not applicable
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Kawakami |
Organization
Nagasaki University Hospital
Division name
Department of Immunology and Rheumatology Nagasaki University Graduate School of Biomedical Sciences
Zip code
Address
1-7-1Sakamoto,Nagasaki
TEL
095-819-7067
atsushik@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Kawashiri |
Organization
Nagasaki University Hospital
Division name
Department of Immunology and Rheumatology Nagasaki University Graduate School of Biomedical Sciences
Zip code
Address
1-7-1Sakamoto,Nagasaki
TEL
095-819-7067
Homepage URL
shin-ya@hotmail.co.jp
Sponsor or person
Institute
Nagasaki University Hospital
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
| 2013 | Year | 12 | Month | 09 | 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
| 2013 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Assess the outcome of treatment Joint supersonic wave,DAS28,SDAI,CDAI,and relationship of serum/Plasma marker for the patients who start treatment molecularly-targeted drug.
Management information
Registered date
| 2013 | Year | 12 | Month | 09 | Day |
Last modified on
| 2016 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014657
