UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Bone structure analysis by 3T-MRI in patients with rheumatoid arthritis
Title of the study (Brief title)	Bone structure analysis using MRI in RA
Region	Japan

Condition
Condition	rheumatoid arthritis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal the features of bone structure using MRI in patients with rheumatoid arthritis and osteoarthritis
Basic objectives2	Others
Basic objectives -Others	To investigate factors which associate bone structure parameters in patients with rheumatoid arthritis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To identify the difference in bone structure parameters between patients with rheumatoid arthritis and osteoarthritis
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Patients diagnosed with rheumatoid arthritis based on the American College of Rheumatology (ACR)/ EULAR 2010 criteria for the classification of RA 2.Patients diagnosed with Osteoarthritis based on the American College of Rheumatology (ACR)1986 criteria
Key exclusion criteria	1) treated with operation 2)infection 3)malignant tumor 4)other collagen disease 5)diabetes mellitus
Target sample size	60

Research contact person
Name of lead principal investigator	Suto Takahito
Organization	Gunma University Graduate School of Medicine
Division name	Orthopaedics
Address	3-39-22, Showamachi, Maebashisi, Gunma, Japan
TEL	027-220-8275
Email	sdosdosdo11@gmail.com

Public contact
Name of contact person	Suto Takahito
Organization	Gunma University Graduate School of Medicine
Division name	Orthopaedics
Address	3-39-22, Showamachi, Maebashisi, Gunma, Japan
TEL	027-220-8275
Homepage URL
Email	sdosdosdo11@gmail.com

Sponsor
Institute	Department of Orthopaedic Surgery, Gunma University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Orthopaedic Surgery, Gunma University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
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	2018 Year 01 Month 31 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 12 Month 18 Day
Anticipated trial start date	2018 Year 02 Month 01 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	Unpublished
URL releasing results
Results
Other related information	nothing particular

Management information
Registered date	2018 Year 01 Month 31 Day
Last modified on	2018 Year 02 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035500