UMIN-CTR Clinical Trial

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
Email	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
Email	minoy@hama-med.ac.jp

Sponsor
Institute	Department of Hospital Pharmacy, Hamamatsu University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054625