UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002931 |
|---|---|
| Receipt number | R000003566 |
| Scientific Title | The influence of polymorphism in methotrexate pathway genes on efficacy and toxicity of methotrexate in patients with juvenile idiopathic arthritis |
| Date of disclosure of the study information | 2009/12/23 |
| Last modified on | 2009/12/22 16:45:18 |
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Basic information
Public title
The influence of polymorphism in methotrexate pathway genes on efficacy and toxicity of methotrexate in patients with juvenile idiopathic arthritis
Acronym
The influence of polymorphism in methotrexate pathway genes on efficacy and toxicity of methotrexate in patients with juvenile idiopathic arthritis
Scientific Title
The influence of polymorphism in methotrexate pathway genes on efficacy and toxicity of methotrexate in patients with juvenile idiopathic arthritis
Scientific Title:Acronym
The influence of polymorphism in methotrexate pathway genes on efficacy and toxicity of methotrexate in patients with juvenile idiopathic arthritis
Region
| Japan |
Condition
Condition
Articular-type juvenile idiopathic arthritis (JIA)
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the influence of gene polymorphisms related to the mechanism of action of methotrexate (MTX) on efficacy and toxicity of MTX in patients with juvenile idiopathic arthritis (JIA)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy and toxicity of methotrexate in patients with JIA
Key secondary outcomes
Subgroup analysis based on (1)time interval between onset and treatment, (2)response to therapy, (3)the level of anti-citrullinated peptide antibodies, and rheumatoid factor.
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
| Not applicable |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients with juvenile idiopathic arthritis who were treated with MTX in our hospital and with prior written informed consent from patients and/or their parents.
Key exclusion criteria
The patient who was judged by physicians as an improper case for enrollment in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakatsu Yanagimachi |
Organization
Yokohama City University School of Medicine
Division name
Pediatrics
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yokohama City University School of Medicine
Division name
Pediatrics
Zip code
Address
TEL
045-787-2800
Homepage URL
Sponsor or person
Institute
Department of Pediatrics, Yokohama City University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Health and labour Sciences Research Grants
Organization
Division
Category of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 23 | 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
Completed
Date of protocol fixation
| 2007 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective case-control study
Management information
Registered date
| 2009 | Year | 12 | Month | 22 | Day |
Last modified on
| 2009 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003566
