UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055177 |
|---|---|
| Receipt number | R000063046 |
| Scientific Title | Pharmacogenetic of methotrexate and establishment of personalised treatment for rheumatoid arthritis. |
| Date of disclosure of the study information | 2024/08/06 |
| Last modified on | 2024/08/08 10:23:00 |
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Basic information
Public title
Pharmacogenetic of methotrexate and establishment of personalised treatment for rheumatoid arthritis.
Acronym
Pharmacogenetic of methotrexate and establishment of personalised treatment for rheumatoid arthritis.
Scientific Title
Pharmacogenetic of methotrexate and establishment of personalised treatment for rheumatoid arthritis.
Scientific Title:Acronym
Pharmacogenetic of methotrexate and establishment of personalised treatment for rheumatoid arthritis.
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To elucidate the association between MTX dosage, drug-metabolising enzyme gene polymorphisms and MTX-PG concentrations in Japanese RA patients and to examine the association between efficacy and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Association of MTX-PG concentrations and drug-metabolising enzyme gene polymorphisms with efficacy and safety indicators.
Key secondary outcomes
N.A.
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients participating in the "Pharmacogenetics and Pharmacokinetics of Methotrexate in Japanese Patients with Rheumatoid Arthritis study"(20130405) and the "Establishment of Personalised Therapy with Methotrexate in Rheumatoid Arthritis study."(20140445)
Key exclusion criteria
Ineligible for the study judged by physicians
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Kaneko |
Organization
Keio University School of Medicine
Division name
Division of Rheumatology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3786
ykaneko.z6@keio.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Kaneko |
Organization
Keio University School of Medicine
Division name
Division of Rheumatology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3786
Homepage URL
ykaneko.z6@keio.jp
Sponsor or person
Institute
Keio University School of medicine
Institute
Department
Personal name
Funding Source
Organization
Nothing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
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
| 2024 | Year | 08 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
600
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
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Integration and analysis of previous data.
Management information
Registered date
| 2024 | Year | 08 | Month | 06 | Day |
Last modified on
| 2024 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063046
