Observational study For Investigating the ability of Recuperation of work/ house work State with Tocilizumab (Actemra) SubCutaneous treatment in biologics-naive RA patients
Phase 4
- Conditions
- rheumatoid arthritis
- Registration Number
- JPRN-UMIN000012306
- Lead Sponsor
- EPS Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 800
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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