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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014025
Receipt No. R000016326
Scientific Title Long-term observational study of finger joint synovitis developing refractoriness in rheumatoid arthritis
Date of disclosure of the study information 2014/06/01
Last modified on 2018/05/24

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Basic information
Public title Long-term observational study of finger joint synovitis developing refractoriness in rheumatoid arthritis
Acronym Observational study of refractory synovitis in rheumatoid arthritis
Scientific Title Long-term observational study of finger joint synovitis developing refractoriness in rheumatoid arthritis
Scientific Title:Acronym Observational study of refractory synovitis in rheumatoid arthritis
Region
Japan

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

Objectives
Narrative objectives1 To study local synovitis developing refractoriness despite having clinical remission in rheumatoid arthritis. We use ultrasonography, magnetic resonance imaging and X-ray of finger joints and study mechanism of developing refractoriness of local synovitis.
Basic objectives2 Others
Basic objectives -Others To study refractory synovitis in rheumatoid arthritis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Joint ultrasonography and clinical assessments are examined at the baseline, 8th, 16th, 24th, 52nd, 76th and 104th week. Magnetic resonance imaging of finger joints and X-ray are performed at the baseline, 24th, 52nd and 104th 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
85 years-old >
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 and/or 2010 ACR/Eulopean League Against Rheumatism (EULAR) classification criteria
2) Patients diagnosed as active state of RA according to clinical information
3) Patients who need to start or adjust anti-rheumatic therapy
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 011-611-1371
Email k.tanimura@pep.ne.jp

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
2014 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://onlinelibrary.wiley.com/doi/full/10.1111/1756-185X.13030
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
2014 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Objective: To study the refractory mechanism of synovitis of finger joint in patients with RA
Design: prospective observational study
Sampling: Patients were examined by joint imaging assessments through study

Management information
Registered date
2014 Year 05 Month 22 Day
Last modified on
2018 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016326

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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