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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004476
Receipt No. R000005347
Scientific Title Observational study for assessing disease activity with quantitative joint power Doppler ultrasonography in patient with rheumatoid arthritis
Date of disclosure of the study information 2010/10/29
Last modified on 2012/11/29

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Basic information
Public title Observational study for assessing disease activity with quantitative joint power Doppler ultrasonography in patient with rheumatoid arthritis
Acronym Assessment of disease activity with quantitative joint power Doppler ultrasonography in patient with rheumatoid arthritis
Scientific Title Observational study for assessing disease activity with quantitative joint power Doppler ultrasonography in patient with rheumatoid arthritis
Scientific Title:Acronym Assessment of disease activity with quantitative joint power Doppler ultrasonography in patient with rheumatoid arthritis
Region
Japan

Condition
Condition Rheumatoid arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate response of synovial vascularity to biological agents, determined by power Doppler ultrasonography, and progression of structural joint damage in rheumatoid arthritis
Basic objectives2 Others
Basic objectives -Others Examine a relation between synovial vascularity and radiographic joint damage
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical and laboratory assessments are examined through study. Radiography of hands and feet are performed at baseline, 20th and the 50th week. Power Doppler ultrasonography is performed at baseline, 8th, 20th and 40th week.
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 Patient who are satisfied the criteria below:
1) Patients who are satisfied American College of Rheumatology 1987 RA diagnostic criteria
2) Patients diagnosed as active state of RA according to DAS28-ESR (>3.2)
3) Patients who are started to be treated with biologics
4) Patients are informed of this protocol and consented to participated
Key exclusion criteria Patients who fulfill one of the following criteria must be excluded:
1) Patients who have apparent infection
2) Female patients who are during pregnancy or lactation
3) Patients who are judged to be inappropriate by investigator
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhide Tanimura
Organization Hokkaido Medical Center for Rheumatic Diseases
Division name Center for Rheumatic Diseases
Zip code
Address 1-45, 3-chome, Kotoni-1jo, Nishi-ku, Sapporo, Hokkaido
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Jun Fukae
Organization Hokkaido Medical Center for Rheumatic Diseases
Division name Center for Rheumatic Diseases
Zip code
Address 1-45, 3-chome, Kotoni-1jo, Nishi-ku, Sapporo, Hokkaido
TEL 011-611-1371
Homepage URL
Email jun.fukae@ryumachi-jp.com

Sponsor
Institute Hokkaido Medical Center for Rheumatic Diseases
Institute
Department

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
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
2010 Year 10 Month 29 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results 
Result: Clinical composite scores for rheumatoid activity were significantly decreased from baseline to 8th week, being sustained at a low level by biologic agents during the observational period. MCP and PIP joints with positive synovial vascularity after 8th week showed more subsequent joint damage progression than joints without synovial vascularity throughout the follow-up.
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
2009 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2013 Year 01 Month 01 Day
Date of closure to data entry
2013 Year 03 Month 01 Day
Date trial data considered complete
2013 Year 03 Month 01 Day
Date analysis concluded
2013 Year 03 Month 01 Day

Other
Other related information Objective: To investigate the relation between synovial vascularity, assessed by quantitative power Doppler ultrasonography, and progression of structural damage in individual finger joint in patients with RA Design: prospective observational study Sampling: Patients were examined by joint imaging assessments through study

Management information
Registered date
2010 Year 10 Month 29 Day
Last modified on
2012 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005347

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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