UMIN-CTR Clinical Trial

Basic information
Public title	PK/PD analysis of methotrexate in the rheumatic treatment made use of genetic polymorphism of drug delivery protein and clinical development
Acronym	PK/PD analysis of methotrexate in the rheumatic treatment and clinical development
Scientific Title	PK/PD analysis of methotrexate in the rheumatic treatment made use of genetic polymorphism of drug delivery protein and clinical development
Scientific Title:Acronym	PK/PD analysis of methotrexate in the rheumatic treatment and clinical development
Region	Japan

Condition
Condition	Rheumatic arthritis
Classification by specialty	Clinical immunology Orthopedics
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	We aim to clarify the influence on the Pharmacokinetics of Methotrexate (MTX) We aim to clarify the influence on the Pharmacokinetics of Methotrexate (MTX) pharmacokinetics by the difference of the miRNA,genetic polymorphism associated the drug transporter of MTX.We also examined the DAS 28 to evaluate the side effect.
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Genetic polymorphism Expression of protein Concentration of Methotrexate in blood DAS28
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1.20-70 years old men and women. 2.The patient who has articular rheumatism diagnosed by classification standard in 1987 of American rheumatic society (ACR). 3.The patient who does not have history of previous of MTX medication and needs MTX treatment. 4.The patient who takes MTX more than 5mg in a week.
Key exclusion criteria	1.History of severe circulatory disease, hepatic disorder,renal disease, digestive system disease, blood disorder, interstitial pneumonia. 2.The patient which treatment of RA is no good. 3.The patient having therapeutic experience of surgical remedy for RA during study participation. 4.A pregnant woman, nursing mother, a person who hope for the pregnancy all over the study period.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takuya Morimoto
Organization	Oita University Hospital
Division name	Clinical pharmacology center
Zip code
Address	1-1 Idaigaika,Hazama,Yufu,Oita
TEL	097-586-5952
Email	morimott@med.oita-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takuya Morimoto
Organization	Oita University Hospital
Division name	Clinical pharmacology center
Zip code
Address	1-1 Idaigaika,Hazama,Yufu,Oita
TEL	097-586-5952
Homepage URL
Email	morimott@med.oita-u.ac.jp

Sponsor
Institute	Oita University Hospital Clinical pharmacology center
Institute
Department

Funding Source
Organization	Research fellowship of a clinic pharmacology study promotion foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	1.Oita University School of Medicine 2.Kyushu University graduate school 3.Oribe clinic 4.Otsuka clinic 5.Mie kinen hospital 6.Osaka rosai Hospital
Name of secondary funder(s)	none

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	2008 Year 12 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
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	No longer recruiting
Date of protocol fixation	2008 Year 01 Month 17 Day
Date of IRB
Anticipated trial start date	2008 Year 10 Month 01 Day
Last follow-up date	2010 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	prospective study

Management information
Registered date	2008 Year 12 Month 29 Day
Last modified on	2014 Year 06 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001741

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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