UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Joint imaging for Rheumatoid Arthritis based on differential phase contrast by X-ray Talbot-Lau interferometry
Title of the study (Brief title)	Detection of cartilage damage in RA with X-ray Talbot-Lau interferometry
Region	Japan

Condition
Condition	Rheumatoid arthritis
Classification by specialty	Medicine in general Clinical immunology Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To detect a cartilage damage in rheumatoid arthritis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Change of maximam cartilao thickness in joint of finger with RA after treatment
Key secondary outcomes	Comparison between obtained image by MRI and X-ray Talbot-Lau interferometry etc

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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) age of 20y/o to 75 y/o 2) RA diagnosed with ACR criteria 3) With active disease and need change in therapy 4) Written informed consent to participate.
Key exclusion criteria	1) The pregnant and lactating female , female who has possibility of the pregnancy. 2) Patients with Steinbrocker classIV 3) Patients who were judged inappropriate to entry this study by physician
Target sample size	45

Research contact person
Name of lead principal investigator	Tomonori Ishii
Organization	Tohoku university hospital
Division name	Hematology and Rheumatology
Address	1-1, Seiryocho, Aobaku, Sendai, Miyagi
TEL	022-717-7165
Email	tishii@med.tohoku.ac.jp

Public contact
Name of contact person	Tomonori Ishii
Organization	Tohoku university hospital
Division name	Hematology and Rheumatology
Address	1-1, Seiryocho, Aobaku, Sendai, Miyagi
TEL	022-717-7165
Homepage URL
Email	tishii@med.tohoku.ac.jp

Sponsor
Institute	Tohoku university hospital
Institute
Department

Funding Source
Organization	Konica Minolta
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Konica Minolta
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	東北大学病院

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 27 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2015 Year 05 Month 15 Day
Anticipated trial start date	2015 Year 09 Month 01 Day
Last follow-up date	2018 Year 07 Month 31 Day
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	X-ray of joint will take at 0 week and 24 week after DMARD treatment start

Management information
Registered date	2015 Year 08 Month 27 Day
Last modified on	2017 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021772