UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001609
Receipt number R000001741
Scientific Title PK/PD analysis of methotrexate in the rheumatic treatment made use of genetic polymorphism of drug delivery protein and clinical development
Date of disclosure of the study information 2008/12/30
Last modified on 2021/09/06 14:32:19

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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 or person

Institute

Oita University Hospital
Clinical pharmacology center

Institute

Department

Personal name



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

Completed

Date of protocol fixation

2008 Year 01 Month 17 Day

Date of IRB

2008 Year 10 Month 01 Day

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

2021 Year 09 Month 06 Day



Link to view the page

Value
https://center6.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