Analysis of Effectiveness and Safety of Abatacept in Japanese patients with Rheumatoid Arthritis.
Not Applicable
- Conditions
- Rheumatoid arthritis
- Registration Number
- JPRN-UMIN000005144
- Lead Sponsor
- Tokyo Medical and Dental university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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