UMIN-CTR Clinical Trial

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
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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
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Research case data
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