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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000716
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Allergy and Rheumatology and
Department of Radiology, University of Tokyo
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000851

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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