UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	To measure the m-RNA of RFC, research on lymphocyte osteoarthritis and rheumatoid arthritis
Title of the study (Brief title)	Folic acid intracellular absorption enzyme RFC activity of arthritis
Region	Japan

Condition
Condition	Osteoarthritis,rheumatoid arthritis
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To measure the m-RNA of RFC, research on lymphocyte in patients with osteoarthritis and rheumatoid arthritis
Basic objectives2	Others
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The difference of the change in the RFC m-RNA
Key secondary outcomes	glycometabolism

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	blood examination study duration: 1days
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with osteoarthritis or rheumatoid arthritis
Key exclusion criteria	Patients who doctors determined to be inappropriate as a subject.
Target sample size	60

Research contact person
Name of lead principal investigator	Seiji　Tsuboi
Organization	Shizuoka Kousei Hospital
Division name	rheumatology
Address	23kitabanncho,aoi-ku,Shizuoka　City
TEL	054-271-7177
Email	ja-sizukousei-ra@krc.biglobe.ne.jp

Public contact
Name of contact person	Seiji　Tsuboi
Organization	Shizuoka Kousei Hospital
Division name	rheumatology
Address	23kitabanncho,aoi-ku,Shizuoka　City
TEL	054-271-7177
Homepage URL
Email	ja-sizukousei-ra@krc.biglobe.ne.jp

Sponsor
Institute	Shizuoka Kousei Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Self funding
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	2016 Year 04 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 09 Month 11 Day
Anticipated trial start date	2016 Year 04 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

Management information
Registered date	2016 Year 04 Month 01 Day
Last modified on	2016 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000025064