UMIN-CTR Clinical Trial

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
Email	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
Email	hashiguchi-ms@pha.keio.ac.jp

Sponsor
Institute	Faculty of Pharmacy, Keio Univeristy Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019827