UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005144 |
|---|---|
| Receipt number | 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 09:01:08 |
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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
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
yamazaki.rheu@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006109
