Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Incidence rate of adverse events (AEs) will be measured. |
Number of patients who develop malignancy, cardiovascular disease, serious infection, inflammatory bowel syndrome, hepatic events, neurological events and general serious adverse events (SAEs) in Japanese clinical practice will be assessed in subjects receiving Conventional synthetic DMARDs, JAK inhibitors, Anti-TNF biologic DMARDs, and Non-TNF biologic DMARDs as standard of care. |
e outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. |
|
Secondary |
The number of tender and swollen joints, 28 joint counts, will be recorded as a measure of disease activity. |
|
1. the outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. |
|
Secondary |
Patient pain assessment will be collected using visual analogue scale measurements (VAS) |
|
The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. |
|
Secondary |
Physician global disease severity assessment will be collected using VAS |
|
The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. |
|
Secondary |
Patient global disease severity assessment will be collected using VAS. |
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The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. |
|
Secondary |
The duration of morning stiffness will be recorded in minutes or hours. enrollment and subsequent visits |
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The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. |
|
Secondary |
The severity of morning stiffness, stiffness and associated pain, will be recorded using VAS. |
|
The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. |
|
Secondary |
DAS-28 ESR rates will be calculated. . |
|
The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. |
|
Secondary |
Composite indices of disease activity: CDAI score, will be calculated from the elements in the CorEvitas Questionnaires. |
|
The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. |
|
Secondary |
Composite indices of disease activity, ACR score, will be calculated from the elements in the CorEvitas Questionnaires. |
|
The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. |
|
Secondary |
Composite indices of disease activity, DAS score, will be calculated from the elements in the CorEvitas Questionnaires. |
|
The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. |
|
Secondary |
PROs will be collected via instruments including the EQ-5D questionnaire. |
|
The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. |
|
Secondary |
PROs will be collected via instruments including the HAQ-DI questionnaire. |
|
The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. |
|
Secondary |
PROs will be collected via instruments including the WPAI questionnaire. |
|
The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. |
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