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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000001609 |
Receipt No. | 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 | 2014/06/30 |
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 |
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Condition | |||
Condition | Rheumatic arthritis | ||
Classification by specialty |
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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 | |
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Purpose of intervention | |
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Eligibility | ||||
Age-lower limit |
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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. |
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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. |
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Target sample size | 300 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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) | |
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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 |
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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 | |
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Results Delay Reason | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
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Other | |
Other related information | prospective study |
Management information | |||||||
Registered date |
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Last modified on |
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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 |