UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027373 |
|---|---|
| Receipt number | R000031368 |
| 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 |
| Date of disclosure of the study information | 2017/05/17 |
| Last modified on | 2020/11/18 19:26:09 |
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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
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
ped029@osaka-med.ac.jp
Sponsor or person
Institute
Department of lifetime clinical immunology, Graduate school of medical and dental sciences, Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031368
