UMIN-CTR Clinical Trial

Basic information
Public title	Study on the concentration of methotrexate polyglutamates in erythrocytes for the purpose of formulating the evidence-based guideline of diagnosis and treatment on juvenile idiopathic arthritis
Acronym	Study on the concentration of methotrexate polyglutamates in erythrocytes in management for juvenile idiopathic arthritis
Scientific Title	Study on the concentration of methotrexate polyglutamates in erythrocytes for the purpose of formulating the evidence-based guideline of diagnosis and treatment on juvenile idiopathic arthritis
Scientific Title:Acronym	Study on the concentration of methotrexate polyglutamates in erythrocytes in management for juvenile idiopathic arthritis
Region	Japan

Condition
Condition	Juvenile idiopathic arthritis
Classification by specialty	Clinical immunology Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The concentration of methotrexate polyglutamates in erythrocytes shows race difference and difference between administration ways. We aim to formulate diagnose and treatment guideline by evaluating concentration of methotrexate polyglutamates and the correlation with efficacy and safety.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Concentration of MTX-PG in every age and administered dose Disease activity score ( JADAS-27)
Key secondary outcomes	Adverse effects (nausea, liver transaminase abnormality, increase of infection)

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	2 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with juvenile idiopathic arthritis who was prescribed the stable dose of methotrexate for 4 weeks
Key exclusion criteria	Patients who was prescribed increasing or decreasing dose of methotrexate in 4 weeks. Patients who was prescribed other immunosuppressants. Patients that the consent to enroll in this study was not obtained.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Nami Middle name Last name Okamoto MD. Ph.D
Organization	Graduate school of medicine, Osaka Medical College
Division name	Department of Pediatrics
Zip code	569-8686
Address	Takatsuki-city
TEL	09038707539
Email	ped029@osaka-med.ac.jp

Public contact
Name of contact person	1st name Nami Middle name Last name Okamoto MD. Ph.D
Organization	Graduate School of Medicine, Osaka Medical College
Division name	Department of Pediatrics
Zip code	569-8686
Address	Takatsuki-city
TEL	09038707539
Homepage URL
Email	ped029@osaka-med.ac.jp

Sponsor
Institute	Department of lifetime clinical immunology, Graduate school of medical and dental sciences, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB of Osaka Medical College
Address	2-7 Daigaku-machi
Tel	072-683-1221
Email	rinri@art.osaka-med.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	2017 Year 05 Month 17 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	Main results already published
Date of protocol fixation	2016 Year 10 Month 20 Day
Date of IRB	2016 Year 07 Month 05 Day
Anticipated trial start date	2016 Year 12 Month 01 Day
Last follow-up date	2022 Year 07 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	prospective study, case control sampling

Management information
Registered date	2017 Year 05 Month 17 Day
Last modified on	2020 Year 11 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031368