UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048381 |
|---|---|
| Receipt number | R000054625 |
| Scientific Title | Prospective observational study to investigate the relationships between pharmacokinetics and therapeutic efficacy and adverse effect of Janus kinase inhibitor in rheumatoid arthritis. |
| Date of disclosure of the study information | 2022/07/15 |
| Last modified on | 2022/07/15 11:07:50 |
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Basic information
Public title
Prospective observational study to investigate the relationships between pharmacokinetics and therapeutic efficacy and adverse effect of Janus kinase inhibitor in rheumatoid arthritis.
Acronym
Prospective observational study to investigate the relationships between pharmacokinetics and therapeutic efficacy and adverse effect of Janus kinase inhibitor in rheumatoid arthritis.
Scientific Title
Prospective observational study to investigate the relationships between pharmacokinetics and therapeutic efficacy and adverse effect of Janus kinase inhibitor in rheumatoid arthritis.
Scientific Title:Acronym
Prospective observational study to investigate the relationships between pharmacokinetics and therapeutic efficacy and adverse effect of Janus kinase inhibitor in rheumatoid arthritis.
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
to investigate the relationship between plasma concentration and efficacy and/or adverse effect of Janus kinase inhibitors
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma concentration of Janus kinase inhibitors
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who take a Janus kinase inhibitor for at least seven days
Those who provided a written consent to participate in the study or whose family provided a written consent to participate in the study
Key exclusion criteria
Those who the doctor in charge deems inappropriate
Those who do not agree to participate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Kawakami |
Organization
Hamamatsu University School of Medicine
Division name
Department of Hospital pharmacy
Zip code
431-3192
Address
1-20-1 Handayama, Hamamatsu 431-3192
TEL
053-435-2623
pharmacyham-adm@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yasuaki |
| Middle name | |
| Last name | Mino |
Organization
Hamamatsu University School of Medicine
Division name
Department of Hospital Pharmacy
Zip code
431-3192
Address
1-20-1 Handayama, Hamamatsu 431-3192
TEL
053-435-2623
Homepage URL
minoy@hama-med.ac.jp
Sponsor or person
Institute
Department of Hospital Pharmacy, Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Hospital Pharmacy, Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Hamamatsu 431-3192
Tel
053-435-2680
rinri@hama-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
| 2022 | Year | 07 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Observational study
Management information
Registered date
| 2022 | Year | 07 | Month | 15 | Day |
Last modified on
| 2022 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054625
