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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005144
Receipt No. R000006109
Scientific Title Analysis of Effectiveness and Safety of Abatacept in Japanese patients with Rheumatoid Arthritis.
Date of disclosure of the study information 2011/02/25
Last modified on 2014/03/24

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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
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
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
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
Email

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
2011 Year 02 Month 25 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
2010 Year 10 Month 19 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
Registered date File name

Research case data
Registered date File name


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