UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002036
Receipt number R000002417
Scientific Title Assessment of disease activity with quantitative joint power Doppler ultrasonography in patient with rheumatoid arthritis
Date of disclosure of the study information 2009/06/18
Last modified on 2010/04/30 20:18:25

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Basic information

Public title

Assessment of 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

Assessment of 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 association between synovial vascularity determined by power Doppler ultrasonography and progression of structural joint damage

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 and 20th week. Power Doppler ultrasonography is performed at baseline and 8th week. Magnetic resonance imaging (MRI) is performed at baseline.

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 (>2.7)
3) 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

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhide Tanimura

Organization

Tokeidai Memorial Hospital

Division name

Center for Rheumatic Diseases

Zip code


Address

Kita-1, Higashi-1, Cyuo-ku, Sapporo, Hokkaido

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Tokeidai Memorial Hospital

Division name

Center for Rheumatic Diseases

Zip code


Address


TEL


Homepage URL


Email

jun.fukae@ryumachi-jp.com


Sponsor or person

Institute

Center for Rheumatic Diseases, Tokeidai Memorial Hospital

Institute

Department

Personal name



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

2009 Year 06 Month 18 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

Results: Quantitative power Doppler ultrasonography (PDUS) was significantly correlated with enhancement rate of MRI in each single finger joint. Comparing quantitative synovial vascularity and radiographic change in single MCP or PIP joint, the level of vascularity at baseline showed significant positive correlation with radiographic progression at the 20th week. The change of vascularity responded to DMARDs, defined as the percentage change in vascularity by the 8th week from baseline, was inversely correlated with radiographic progression in each MCP joint. Quantitative PDUS method was more useful than semi-quantitative method for the evaluation of synovial vascularity in single finger joint.

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 11 Month 30 Day

Date of IRB


Anticipated trial start date

2007 Year 12 Month 01 Day

Last follow-up date

2010 Year 01 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



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

2009 Year 06 Month 03 Day

Last modified on

2010 Year 04 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002417


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name