rheumatoid arthritis
Conditions
Interventions
None listed
Sponsors
EPS Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Age => 20 years at registration (2) Diagnosis of rheumatoid arthritis according to the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria (3) Currently being treated with one or more conventional DMARDs (4) Patients engaged in work (either salaried or self-employed) or the patients primarily responsible for the housework in a family (5) Disease activity as evidenced by DAS28-ESR ≥ 3.2 (6) Patients who did not receive biological DMARDs treatment previously. (7) Attending physician has determined that the patient is eligible for treatment with a biological agent, in accordance with the guidelines on the use of biological agents in rheumatoid arthritis of the Japan College of Rheumatology (8) Patients who want to be treated with TCZ-SC or who want to switch to, add, or increase the dose of a DMARD other than a biological agent (9) Consent to study participation has been obtained in writing from the patient personally
Exclusion criteria
Exclusion criteria: (1) Patients who cannot use the drug in this study by contraindication. (2) The principal investigator or co-investigator has determined that the participation of the patient in the study would not be appropriate (3) Patients who have been registered and examined in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in percent overall work impairment (at the last observation, up to week 52) in paid workers, by the Work Productivity and Activity Impairment Questionnaire (WPAI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the percentage of presenteeism, absenteeism, and activity impairment of daily work by WPAI Change in employment rate by WPAI Changes in WFun Changes in Frenchay Activities Index (FAI) among house workers Changes in EuroQol 5 Dimension (EQ5D) Changes in Health Assessment Questionnaire Disability Index (some questions are replaced to accommodate Japanese lifestyle differences and have been validated/confirmed) Changes in disease activity by DAS28-ESR, Clinical disease activity index (CDAI), Simplified disease activity index (SDAI) Conductes to assess the relationship between characteristics and each assessment outcome | — |
Countries
Japan
Contacts
Public ContactHideki Furuya
EPS Corporation Clinical Coodinating Center Clinical Coodinating Department
Outcome results
None listed