UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017104 |
|---|---|
| Receipt number | R000019827 |
| Scientific Title | Personalized therapy for methotrexate in patients with rheumatoid arthritis |
| Date of disclosure of the study information | 2015/04/11 |
| Last modified on | 2021/05/01 11:20:55 |
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Basic information
Public title
Personalized therapy for methotrexate in patients with rheumatoid arthritis
Acronym
Personalized therapy for methotrexate
Scientific Title
Personalized therapy for methotrexate in patients with rheumatoid arthritis
Scientific Title:Acronym
Personalized therapy for methotrexate
Region
| Japan |
Condition
Condition
Rheumatoid arthiritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To establish the personalized therapy for methotrexate in patients with rheumatoid arthritis in Japan, we investigate the genotype frequencies of enzyme and transporter related to methotrexate, the concentration of methotrexate polyglutamates (MTX-PGs) in red blood cell, frequencies of DNA methylation in patients with rheumatoid arthritis and the influence on the association between effectiveness and safety of methotrexate.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical effectiveness such as DAS28, etc.
Key secondary outcomes
genotype frequencies of enzyme and transporter related to methotrexate, the concentration of methotrexate polyglutamates (MTX-PGs), frequencies of DNA methylation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Among patient who get outpatient treatment in the University Hospital and have the prescription history of methotrexate, and/or will newly start to prescribe methotrexate, all patients who we could get informed consent for this study are target population
Key exclusion criteria
Nothing special defined
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mayumi Mochizuki |
Organization
Keio Univeristy
Division name
Faculty of Pharmacy
Zip code
Address
1-5-30 Shibakouen, Minato-ku, Tokyo
TEL
03-5400-2120
mochizuki-my@pha.keio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Hashiguchi |
Organization
Keio Univeristy
Division name
Faculty of Pharmacy
Zip code
Address
1-5-30 Shibakouen, Minato-ku, Tokyo
TEL
03-5400-2120
Homepage URL
hashiguchi-ms@pha.keio.ac.jp
Sponsor or person
Institute
Faculty of Pharmacy, Keio Univeristy
Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University
Institute
Department
Personal name
Funding Source
Organization
Faculty of Pharmacy, Keio Univeristy
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
| 2015 | Year | 04 | Month | 11 | 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
| 2014 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing special
Management information
Registered date
| 2015 | Year | 04 | Month | 11 | Day |
Last modified on
| 2021 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019827
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
