UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000716 |
|---|---|
| Receipt number | R000000851 |
| Scientific Title | The Evaluation of Inflammatory Activity in Rheumatoid Arthritis by Using Fludeoxyglucose (18F) |
| Date of disclosure of the study information | 2007/05/11 |
| Last modified on | 2009/11/11 18:03:59 |
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Basic information
Public title
The Evaluation of Inflammatory Activity in Rheumatoid Arthritis by Using Fludeoxyglucose (18F)
Acronym
The Evaluation of RA activity by FDG-PET
Scientific Title
The Evaluation of Inflammatory Activity in Rheumatoid Arthritis by Using Fludeoxyglucose (18F)
Scientific Title:Acronym
The Evaluation of RA activity by FDG-PET
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology | Orthopedics | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the utility of FDG-PET in evaluating activity of rheumatoid arthritis
Basic objectives2
Others
Basic objectives -Others
Comparing the clinical evaluation of RA (physical examination and laboratory data) and the findings of synovitis in hand MRI, with the SUV in FDG-PET (adjusted by weighting at each joint)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The clinical evaluation of RA (physical examination and laboratory data), the findings of synovitis in hand MRI with contrast, and the SUV in FDG-PET (adjusted by weighting at each joint)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
active RA patient who fulfills all the criteria below:
1) diagnosed with RA by ACR criteria revised in 1987
2) more than 20 years old and who is able to self-judge
3) fully informed about this study and voluntarily consented for the enrollment
4) judged to be well-suited by the principal investigator or subinvestigator
Key exclusion criteria
patient who fulfills one of the following criteria must be excluded:
1) coexistence of arthropathy other than RA
2) complicated by clinically apparent infection or vasculitis
3) blood glucose more than 150mg/dL at the administration of 18F-FDG
4) under administration of infusion which contains glucose, or on insulin treatment
5) female patient during pregnancy or lactation
6) contraindicated for MRI
7) contraindicated for contrast-material infusion in MRI
8) judged to be inappropriate by the principal investigator or subinvestigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Yamamoto |
Organization
University of Tokyo
Division name
Department of Allergy and Rheumatology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
University of Tokyo
Division name
Department of Allergy and Rheumatology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Department of Allergy and Rheumatology and
Department of Radiology, University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
None declared
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
| 2007 | Year | 05 | Month | 11 | 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
| 2007 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 12 | Month | 01 | Day |
Other
Other related information
all participants will be evaluated by FDG-PET, hand MRI with contrast, and clinical examination and laboratory data, in one week per each patient.
Management information
Registered date
| 2007 | Year | 05 | Month | 11 | Day |
Last modified on
| 2009 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000851
