Rheumatoid Arthritis
Conditions
Interventions
None listed
Sponsors
Department of Internal Medicine, Toho University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients diagnosed with RA based on the 2010 RA diagnostic criteria of the ACR/EULAR,and from whom written consent for participation in the study can be obtained.Among RA patients who are refractory to nonbiological conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and have no history of treatment with biological drugs. RA patients in whom abatacept (ABT) is newly started and young (20 to 64 years old) and elderly (65 years or older), and RA patients in whom a new csDMARD is started (addition or change of csDMARDs).
Exclusion criteria
Exclusion criteria: 1)Patients who correspond to the contraindications of abatacept 2)Patients with active infection and malignant tumor 3)Patients aged less than 20 years 4)Pregnant and lactating women and women who are willing to become pregnant 5)Patients from whom consent for participation in the study cannot be obtained 6)Patients who are judged inappropriate for participation in the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EULAR good response rate at 6 months will be compared between the ABT and csDMARD groups in young patients and in elderly patients. Changes in intima-media thickness by carotid duplex at 3 years will be compared between the ABT and csDMARD groups in young patients and in elderly patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)EULAR moderate response rate, changing in DAS28 score, remission, low-disease activity and moderate-disease activity rates in DAS28, changing in SDAI and CDAI score, remission rate in SDAI and CDAI, and Boolean remission rate at 6 months will be compared between the ABT and csDMARD groups in young patients and in elderly patients. 2)EULAR good and moderate response rates, changing in DAS28 score, remission, low-disease activity and moderate-disease activity rates in DAS28, changing in SDAI and CDAI score, remission rate in SDAI and CDAI, Boolean remission rate, changing in Total Sharp Score, and HAQ score at 1, 2 and 3 years will be compared between the ABT and csDMARD groups in young patients and in elderly patients. 3)Changes in intima-media thickness by carotid duplex, PWV and ABI at 1, 2 and 3 years will be compared between the ABT and csDMARD groups in young patients and in elderly patients. The relationship between RA disease activity (efficacy of ABT on RA) and atherosclerosis will be analyzed. 4)The ABT continuation rate will be compared between young and elderly patients up to 3 years. 5)The frequency of serious infection will be compared between the ABT and csDMARD groups. The risk factors of onset will be analyzed and compared between young and elderly patients. The type, etc. of infection will also be analyzed in detail. | — |
Countries
Japan
Contacts
Public ContactMegumi Nagasaki
Teikyo University Teikyo Academic Research Center
Outcome results
None listed