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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Rheumatoid arthritis | |
Classification by specialty |
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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 | |
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Purpose of intervention | |
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Eligibility | ||||
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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 |
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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. |
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Target sample size | 300 |
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Name of lead principal investigator |
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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 |
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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 | |
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 | |
Institutions |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Progress | |||||||
Recruitment status | Completed | ||||||
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006109 |
Research Plan | |
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Research case data | |
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