UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Long-term observational study of finger joint synovitis developing refractoriness in rheumatoid arthritis
Title of the study (Brief title)	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	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	2014 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://onlinelibrary.wiley.com/doi/full/10.1111/1756-185X.13030
Results
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