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
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
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
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
