Analysis of Effectiveness and Safety of Abatacept in Japanese patients with Rheumatoid Arthritis.

Analysis of Effectiveness and Safety of Abatacept in Japanese patients with Rheumatoid Arthritis. - Effectiveness and Safety of Abatacept in Japan

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000005144

Enrollment

300

Registered

2011-02-25

Start date

2010-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactHayato Yamazaki

Tokyo Medical and Dental university Department of Pharmacovigilance, Department of Medicine and Rheumatology

yamazaki.rheu@tmd.ac.jp03-5803-4677

Outcome results