UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027250 |
|---|---|
| Receipt number | R000031217 |
| Scientific Title | Precision medicine of methotrexate in the patients with rheumatoid arthritis |
| Date of disclosure of the study information | 2017/05/08 |
| Last modified on | 2021/01/31 21:34:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Precision medicine of methotrexate in the patients with rheumatoid arthritis
Acronym
Methotrexate precision medicine
Scientific Title
Precision medicine of methotrexate in the patients with rheumatoid arthritis
Scientific Title:Acronym
Methotrexate precision medicine
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To establish the precision medicine of methotrexate, we clarify the factors related to individual drug response including genetic information
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MTX therapeutic response and adverse drug reaction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
MTX administration
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
In patient with rheumatoid arthritis and/or osteoarthritis, they have scheduled surgery of total Hip Arthroplasty (THA) and/or total Knee Arthroplasty (TKA) and administered MTX or no administration of MTX
Key exclusion criteria
Patients including infectious disease (Hepatitis B, C, HIV, syphilis) ministration of MTX
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Hashiguchi |
Organization
Keio University
Division name
Faculty of Pharmacy
Zip code
Address
1-5-30 Shibakoen, Minato-ku, Tokyo
TEL
03-5400-2120
hashiguchi-ms@pha.keio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Hashiguchi |
Organization
Keio University
Division name
Faculty of Pharmacy
Zip code
Address
1-5-30 Shibakoen, Minato-ku, Tokyo
TEL
03-5400-2120
Homepage URL
hashiguchi-ms@pha.keio.ac.jp
Sponsor or person
Institute
Keio University
Fukuoka Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
Keio University
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
医療法人徳洲会 福岡徳洲会病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 05 | Day |
Last modified on
| 2021 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031217
