UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of finger joint with positive synovial vascularity in patient with rheumatoid arthritis under low disease activity
Title of the study (Brief title)	Study of finger joint with positive synovial vascularity
Region	Japan

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

Objectives
Narrative objectives1	To inevestigate change of synovial vascularity and prognosis of finger joint with positive synovial vascularity despite under low disease activity
Basic objectives2	Others
Basic objectives -Others	Relation between change of synovial vascularity and bone damage progression
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 52nd week. Power Doppler ultrasonography is performed at baseline, 8th, 20th and 52nd 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 (ACR) 1987 RA classification criteria or 2010 ACR/European League Against Rheumatism (EULAR) classification criteria 2) Patients diagnosed as low disease activity state of RA according to clinical decision by investigator 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	30

Research contact person
Name of lead principal investigator	Kazuhide Tanimura
Organization	Hokkaido Medical Center for Rheumatic Diseases
Division name	Center for Rheumatic Diseases
Address	1-45, 3-chome, Kotoni-1jo, Nishi-ku, Sapporo, Hokkaido
TEL	011-611-1371
Email	k.tanimura@pep.ne.jp

Public contact
Name of contact person	Jun Fukae
Organization	Hokkaido Medical Center for Rheumatic Diseases
Division name	Center for Rheumatic Diseases
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)

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	2012 Year 02 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 09 Month 30 Day
Anticipated trial start date	2011 Year 10 Month 01 Day
Last follow-up date	2014 Year 04 Month 01 Day
Date of closure to data entry	2014 Year 04 Month 01 Day
Date trial data considered complete	2014 Year 04 Month 01 Day
Date analysis concluded	2014 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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	2012 Year 02 Month 16 Day
Last modified on	2017 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008605