UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of Effectiveness and Safety of Abatacept in Japanese patients with Rheumatoid Arthritis.
Acronym	Effectiveness and Safety of Abatacept in Japan
Scientific Title	Analysis of Effectiveness and Safety of Abatacept in Japanese patients with Rheumatoid Arthritis.
Scientific Title:Acronym	Effectiveness and Safety of Abatacept in Japan
Region	Japan

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

Objectives
Narrative objectives1	Abatacept, which suppresses T cells by binding with CD80/CD86 of antigen-presenting cells, was newly developed and approved in Japan for treatment of rheumatoid arthritis (RA) in September 2010. Some clinical trials implemented in Western countries and Japan suggested that the efficacy and safety of abatacept were equivalent to other existing biologic agents and the incidence of serious adverse events was relatively low. However, evidence of effectiveness and safety of abatacept in Japanese patients in the real world has not sufficiently proved yet and remains to be established. Therefore, we planned this study to clarify effectiveness and safety of abatacept in Japanese patients with RA and to find predictive factors for effectiveness. In addition, we also analyze comprehensive gene expression information from blood samples obtained at the initiation of and 6 months after the therapy with clinical information to find candidate genes associated with the effectiveness and safety of abatacept.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Effectiveness of abatacept: EULAR response rate at month 6; ACR/EULAR remission rate at month 6 Safety of abatacept: incidence of serious adverse drug reactions; incidence of serious infection during 1 year
Key secondary outcomes	Effectiveness of abatacept: changes of joint scores, acute inflammatory response, and visual analogue scales over time; changes of Total Sharp Score at year 1; percentages of patients with delta Total Sharp Score <0.5; changes of physical function over time (HAQ, EQ-5D). Safety of abatacept: incidence of adverse events and adverse drug reactions during 1 year; incidence of infection during 1 year Other outcomes: analysis of mRNA expression with clinical information

Base
Study type	Observational

Study design
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Randomization
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Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	A Patient of rheumatoid arthritis(RA) who meets all of the following will be eligible to the study. 1.A patient who is older than 20 years old 2.A patient who fulfills the 2010 ACR/EULAR classification criteria of RA 3.A patient whose disease activity remains moderate or high despite treatment with disease modifying anti-rheumatic drugs such as methotrexate more than 3 months. 4.A Patient who starts to use abatacept for the first time 5.A Patient who provides a written informed consent to join this study
Key exclusion criteria	A patient who has any of the following will be excluded from the study. 1.When a patient withdraws his or her consent. 2.When a doctor judges a patient not appropriate to join the study. 3.When a patient is pregnant or has possibility to be pregnant. 4.When a patient is under breast-feeding. 5.When a patient is under contraindication of abatacept.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masayoshi Harigai
Organization	Tokyo Medical and Dental university
Division name	Department of Pharmacovigilance, Department of Medicine and Rheumatology
Zip code
Address	5-45,Yushima 1-chome, Bunkyo-ku, Tokyo
TEL	03-5803-4677
Email	mharigai.phv@tmd.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hayato Yamazaki
Organization	Tokyo Medical and Dental university
Division name	Department of Pharmacovigilance, Department of Medicine and Rheumatology
Zip code
Address	1-5-45, Yushima, Bunkyoku
TEL	03-5803-4677
Homepage URL	https://iipsg.thurch.org/procgi10/procgi.exe?P=AS_ABA&writesheet=Login
Email	yamazaki.rheu@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental university
Institute
Department

Funding Source
Organization	Department of Pharmacovigilance, Tokyo Medical and Dental university
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Secondary IDs
Secondary IDs	NO
Study ID_1
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Study ID_2
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IND to MHLW

Institutions
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Other administrative information
Date of disclosure of the study information	2011 Year 02 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 10 Month 19 Day
Date of IRB
Anticipated trial start date	2010 Year 10 Month 01 Day
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Other

Other related information

Primary outcome: Effectiveness of abatacept: EULAR response rate at month 6; ACR/EULAR remission rate at month 6 Safety of abatacept: incidence of serious adverse drug reactions; incidence of serious infection during 1 year Key secondary outcomes: Effectiveness of abatacept: changes of joint scores, acute inflammatory response, and visual analogue scales over time; changes of Total Sharp Score at year 1; percentages of patients with delta Total Sharp Score <0.5; changes of physical function over time (HAQ, EQ-5D). Safety of abatacept: incidence of adverse events and adverse drug reactions during 1 year; incidence of infection during 1 year Other outcomes: analysis of mRNA expression with clinical information

Management information
Registered date	2011 Year 02 Month 25 Day
Last modified on	2014 Year 03 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006109

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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