Rheumatoid arthritis
Conditions
Interventions
None listed
Sponsors
Juntendo University School of Medicine, Department of Internal Medicine and Rheumatology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Research subjects Patients with rheumatoid arthritis who are attending or hospitalized at the institutions participating in the study will be included in the study. (2) Selection criteria Patients who meet all of the following criteria (items 1-7) will be included in this study. 1)Patients with RA who meet the 2010 ACR/EULAR classification criteria (Aletaha D, et al:2010 Rheumatoid arthritis classification criteria) 2)RA patients with disease activity 3)bDMARD-naive patients who have had an inadequate response to one or more conventional synthetic anti-rheumatic drugs (csDMARDs) on previous treatment 4)Patients who meet the following criteria for blood tests: a)Peripheral blood white blood cell count: 4,000/mm3 or higher b)Peripheral blood lymphocyte count: more than 1,000/mm3 c)Blood beta-D-glucan negative 5)Patients who are 20 years of age or older at the time of obtaining consent to participate in this study 6)Patients who understand the principal investigator or sub-researcher's explanation of the research procedure and who can obtain written consent to participate in the research of their own volition 7)Patients who began subcutaneous administration of abatacept by the decision of their doctor
Exclusion criteria
Exclusion criteria: Patients who violate the following criteria (items 1-5) at the time of eligibility determination before obtaining consent shall be excluded. 1) Patients with a history of hypersensitivity to the ingredients of abatacept preparations 2) Patients with malignant tumor 3) Patients with active infections 4) Hepatitis B and hepatitis B virus carriers (HBsAg positive) 5) Pregnant or lactating patients, or potentially pregnant or lactating patients 6) Patients who are judged by the investigator or investigator to be ineligible for participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Simplified disease activity index (SDAI) remission rate at 12 months with subcutaneous administration of abatacept | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Evaluate the achievement rate of low disease activity of SDAI at 12 months after administration 2)Determine patient HLA genotype 3)The following items before administration, 6 months, 12 months, 24 months a)Changes in the proportion of disease activity categories by SDAI, CDAI, DAS28-ESR, DAS28-CRP b)Transition of SDAI, CDAI, DAS28-ESR and DAS28-CRP c)Evaluation of therapeutic responsiveness by DAS28-ESR and DAS28-CRP d)Transition of Japanese version health evaluation questionnaire (J-HAQ) score e)Transition of mTSS joint destruction score f)Changes in anti-CCP antibody titer and ACPA by antigen g)Transition of rheumatoid factor (RF) | — |
Countries
Japan
Contacts
Public ContactMakio Kusaoi
Juntendo University School of Medicine Department of Internal Medicine and Rheumatology
Outcome results
None listed