Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Percentage of Participants Achieving 28-Joint Disease Activity Score (DAS28) C-reactive protein (CRP) Remission following initiation of treatment with Upadacitinib |
The DAS28 CRP is a composite measure of a patient's level of disease activity at a given time. The score ranges from 0-9.4 with a higher score correlating to higher disease activity. Remission is defined as a DAS28 CRP <2.6. |
6 Months |
|
Secondary |
Percentage of Participants Achieving DAS28 CRP Remission following Initiation of Treatment with Upadacitinib |
The DAS28 CRP is a composite measure of a patient's level of disease activity at a given time. The score ranges from 0-9.4 with a higher score correlating to higher disease activity. Remission is defined as a DAS28 CRP <2.6. |
Up to 12 Months |
|
Secondary |
Percentage of Participants Achieving DAS28 CRP Remission at month 6 and maintain it in all subsequent visits |
The DAS28 CRP is a composite measure of a patient's level of disease activity at a given time. The score ranges from 0-9.4 with a higher score correlating to higher disease activity. Remission is defined as a DAS28 CRP <2.6. |
Up to 12 Months |
|
Secondary |
Percentage of Participants Achieving DAS28 CRP Low Disease Activity (LDA) following Initiation of Treatment with Upadacitinib |
The DAS28 CRP is a composite measure of a patient's level of disease activity at a given time. The score ranges from 0-9.4 with a higher score correlating to higher disease activity. Low disease activity is defined as DAS28 CRP <=3.2. |
Up to 12 Months |
|
Secondary |
Percentage of Participants Achieving DAS28 CRP Low Disease Activity at month 6 and maintain it in all subsequent visits |
The DAS28 CRP is a composite measure of a patient's level of disease activity at a given time. The score ranges from 0-9.4 with a higher score correlating to higher disease activity. Low disease activity is defined as DAS28 CRP <=3.2. |
Up to 12 Months |
|
Secondary |
Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score |
The HAQ-DI assesses physical function in RA. The HAQ-DI score is the average of the highest score in each of eight categories. The total score is between 0-3.0, in 0.125 increments. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment |
Up to 12 Months |
|
Secondary |
Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score |
The FACIT-Fatigue Scale measures an individual's level of fatigue during their usual daily activities over the past week on a four-point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The score range for FACIT-Fatigue is between 0 and 52. A score of less than 30 indicates severe fatigue. The higher the score, the better the quality of life. |
Up to 12 Months |
|
Secondary |
Change from Baseline in EQ-5D-5L Score |
The EQ-5D-5L comprises of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The respondent selects one of three different levels of problem severity. The levels are none, moderate and severe/extreme (coded 1 through 3, respectively). |
Up to 12 Months |
|
Secondary |
Change from Baseline in Morning Stiffness Visual Analogue Scale (VAS) Score |
The participant's level of morning stiffness in the past 7 days will be measured using a VAS. VAS scores range from 0 to 100 points with a higher score indicating severity of morning stiffness. |
Up to 12 months |
|
Secondary |
Change from Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Score |
TSQM scores have a range of 0 to 100, with higher scores indicating higher satisfaction. The 14 items of the TSQM cover four domains: Effectiveness, Side Effects, Convenience, and Global Satisfaction. |
Up to 12 Months |
|
Secondary |
Change from Baseline in Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis (WPAI-RA) Score |
The WPAI-RA measures the impact of health problems on presenteeism, absenteeism, total work productivity impairment, total activity impairment using a 0 to 10 VAS. |
Up to 12 Months |
|
Secondary |
Health Resource Utilization (HRU) Questionnaire - Difference in the Number of Hospital Inpatient Days |
Difference in the number of hospital inpatient days during 12 months of upadacitinib therapy and 12 months preceding the introduction of upadacitinib therapy. |
12 months prior to month 0 (baseline) and 12 months prior to month 12 |
|
Secondary |
HRU Questionnaire - Difference in the Number of Hospitalizations |
Difference in the number of hospital inpatient days during 12 months of upadacitinib therapy and 12 months preceding the introduction of upadacitinib therapy. |
12 months prior to month 0 (baseline) and 12 months prior to month 12 |
|
Secondary |
HRU Questionnaire - Difference in the Number of Sick Leave Days (in employed subjects only) |
Difference in the number of hospital inpatient days during 12 months of upadacitinib therapy and 12 months preceding the introduction of upadacitinib therapy. |
12 months prior to month 0 (baseline) and 12 months prior to month 12 |
|
Secondary |
HRU Questionnaire - Difference in the Number of Sick Leaves (in employed subjects only) |
Difference in the number of sick leaves during 12 months of upadacitinib therapy and 12 months preceding the introduction of upadacitinib therapy. |
12 months prior to month 0 (baseline) and 12 months prior to month 12 |
|
Secondary |
HRU Questionnaire - Difference in the Number of Outpatient Visits to Each Kind of Health Care Provider |
Difference in the number of outpatient visits to each kind of health care provider which includes general practitioner, rheumatologist, other specialists (ophthalmologist, gastroenterologist, dermatologist, physiatrist), physiotherapist and rheumatology nurses during 12 months of upadacitinib therapy and 12 months preceding the introduction of upadacitinib therapy. |
12 months prior to month 0 (baseline) and 12 months prior to month 12 |
|
Secondary |
Percentage of Participants remaining on Upadacitinib treatment |
Percentage of participants remaining on upadacitinib up to 12 months post initiation. |
Up to 12 Months |
|