UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006061 |
|---|---|
| Receipt number | R000007177 |
| Scientific Title | The clinical assessment of rheumatoid arthritis using FDG-PET |
| Date of disclosure of the study information | 2011/07/28 |
| Last modified on | 2011/07/28 15:59:43 |
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Basic information
Public title
The clinical assessment of rheumatoid arthritis using FDG-PET
Acronym
The assessment of rheumatoid arthritis using FDG-PET
Scientific Title
The clinical assessment of rheumatoid arthritis using FDG-PET
Scientific Title:Acronym
The assessment of rheumatoid arthritis using FDG-PET
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we evaluated if the FDG uptake of the affected joints represented by SUV correlated with the clinical assessment of patients with RA .
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
a correlation between the difference of SUV and improvement of clinical findings in RA patients
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
DMARDs and Biologics
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
ACR1987 criteria RA patients.
Informed consent is obtained from each patietns .
Key exclusion criteria
RA patietns who can not be treated by biologics.
RA patietns who has overlap collagen diseases.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Okamura |
Organization
Gunma University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
Showamachi 3-39-15, Maebasi, Gunma
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Okamura |
Organization
Gunma University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
Showamachi 3-39-15, Maebasi, Gunma
TEL
Homepage URL
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
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
| 2011 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | 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
Management information
Registered date
| 2011 | Year | 07 | Month | 28 | Day |
Last modified on
| 2011 | 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=R000007177
