UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory research to analyze the effects of disease susceptibility genes on therapeutic response and autoantibodies in rheumatoid arthritis
Acronym	Research to analyze the effects of disease susceptibility genes on therapeutic response and autoantibodies in rheumatoid arthritis
Scientific Title	Exploratory research to analyze the effects of disease susceptibility genes on therapeutic response and autoantibodies in rheumatoid arthritis
Scientific Title:Acronym	Research to analyze the effects of disease susceptibility genes on therapeutic response and autoantibodies in rheumatoid arthritis
Region	Japan

Condition
Condition	Rheumatoid arthritis
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The aim of this study is to analyze the therapeutic response after treatment in targeted synthetic, biological, and conventional synthetic disease modifying antirheumatic drugs (DMARDs) according to the presence or absence of human leukocyte antigen(HLA) and shared epitope (SE).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison of clinical disease activity at 3, 6, and 12 months after the treatment between treatments with targeted synthetic/biological DMARDs and conventional synthetic DMARDs according to the presence or absence of human leukocyte antigen(HLA) and shared epitope (SE).
Key secondary outcomes	Comparison of ultrasound activity at 6 and 12 months after the treatment between treatments with targeted synthetic/biological DMARDs and conventional synthetic DMARDs according to the presence or absence of human leukocyte antigen(HLA) and shared epitope (SE). Comparison of autoantibody titers at 3 and 12 months after the treatment between treatments with targeted synthetic/biological DMARDs and conventional synthetic DMARDs according to the presence or absence of HLA and SE.

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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who have already participated in previous studies associated with rheumatoid arthritis at our institution and who have obtained consent for this study.
Key exclusion criteria	Not applicable
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Kawakami
Organization	Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Medical Sciences
Division name	Department of Immunology and Rheumatology
Zip code	852-8501
Address	1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL	095-819-7260
Email	atsushik@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Yushiro Middle name Last name Endo
Organization	Nagasaki University Hospital
Division name	Department of Immunology and Rheumatology
Zip code	852-8501
Address	1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL	095-819-7260
Homepage URL
Email	yushiro19861105@hotmail.co.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

Funding Source
Organization	Ono Pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Clinical Research Center, Nagasaki University
Address	1-7-1 Sakamoto, Nagasaki 852-8501, Japan
Tel	095-819-7726
Email	toshimasashimizu2000@yahoo.co.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	2020 Year 05 Month 01 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	2020 Year 03 Month 17 Day
Date of IRB	2020 Year 04 Month 20 Day
Anticipated trial start date	2020 Year 05 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Not applicable

Management information
Registered date	2020 Year 04 Month 30 Day
Last modified on	2020 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045952