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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04497597
Registration number
NCT04497597
Ethics application status
Date submitted
30/07/2020
Date registered
4/08/2020
Date last updated
7/06/2024
Titles & IDs
Public title
A Study of Oral Upadacitinib Tablets to Assess Treatment Patterns, Achievement of Treatment Targets and Maintenance of Response in Adult Participants With Moderate to Severe Rheumatoid Arthritis
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Scientific title
Upadacitinib Treatment Patterns, Achievement of Treatment Targets and Maintenance of Response in Moderate to Severe Rheumatoid Arthritis Patients in Real-World Practice (UPHOLD)
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Secondary ID [1]
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P20-095
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Universal Trial Number (UTN)
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Trial acronym
UPHOLD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis (RA)
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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0
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Rheumatoid arthritis
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Participants receiving Upadacitinib - Participants receiving Upadacitinib for moderate to severe rheumatoid arthritis (RA).
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Who Achieve Remission
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Assessment method [1]
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Remission is defined as Disease Activity Score at 28 joints (DAS28) C-reactive Protein (CRP)<2.6.
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Timepoint [1]
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At Month 6
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Primary outcome [2]
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Percentage of Participants Who Achieve Remission at 6 Months and Maintain Remission
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Assessment method [2]
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Remission is defined as DAS28-CRP<2.6. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.
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Timepoint [2]
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At Month 12
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Secondary outcome [1]
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Percentage of Participants Who Achieve Remission at 6 Months and Maintain Remission
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Assessment method [1]
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Remission is defined as DAS28-CRP<2.6. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.
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Timepoint [1]
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At Month 24
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Secondary outcome [2]
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Percentage of Participants Who Achieve Low Disease Activity (LDA) at 6 months that maintain LDA
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Assessment method [2]
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LDA is defined as DAS28-CRP=3.2. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.
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Timepoint [2]
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Through Month 24
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Secondary outcome [3]
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Percentage of Participants Who Achieve Remission at 3 Months and Maintain Remission
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Assessment method [3]
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Remission is defined as DAS28-CRP<2.6. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.
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Timepoint [3]
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Through Month 24
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Secondary outcome [4]
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Percentage of Participants Who Achieve Remission at 6 Months and Maintain Remission Grouped by Glucocorticoid Dose
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Assessment method [4]
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Remission is defined as DAS28-CRP<2.6. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.
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Timepoint [4]
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At Month 12
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Secondary outcome [5]
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Percentage of Participants Who Achieve LDA at 3 months that maintain LDA Grouped by Glucocorticoid Dose
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Assessment method [5]
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LDA is defined as DAS28-CRP=3.2. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.
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Timepoint [5]
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Through Month 6
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Secondary outcome [6]
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Percentage of Participants in LDA that Achieve Glucocorticoid Dose <5 mg/Day Per Visit
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Assessment method [6]
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LDA is defined as DAS28-CRP<3.2.
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Timepoint [6]
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Through Month 24
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Secondary outcome [7]
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Percentage of Participants in Remission that Achieve Glucocorticoid Dose <5 mg/Day Per Visit
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Assessment method [7]
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Remission is defined as DAS28-CRP<2.6.
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Timepoint [7]
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Through Month 24
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Secondary outcome [8]
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Percentage of Participants Who Achieved a Glucocorticoid Dose <5 mg/Day Without Conventional Synthetic Disease Modifying Anti Rheumatic Drug (csDMARD) Intensification
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Assessment method [8]
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Percentage of participants who achieved a glucocorticoid dose <5 mg/day without csDMARD intensification.
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Timepoint [8]
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At Month 6
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Secondary outcome [9]
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Percentage of Participants Who Initiated Upadacitinib as Combination Therapy (csDMARD +/- Glucocorticoids) That Moved to Monotherapy (+/- Glucocorticoids)
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Assessment method [9]
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Percentage of participants who initiated Upadacitinib as combination therapy (csDMARD +/- Glucocorticoids) that moved to monotherapy (+/- glucocorticoids).
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Timepoint [9]
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Through Week 24
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Secondary outcome [10]
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Of the Participants Initiating Upadacitinib as Combination Therapy (csDMARD +/- Glucocorticoids) and Achieve Remission at 6 months, the Percentage of Participants that Maintain Remission Grouped by Maintenance of Combination Therapy Strategy
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Assessment method [10]
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Remission is defined as DAS28-CRP<2.6.
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Timepoint [10]
0
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Through Month 24
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Secondary outcome [11]
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Of the Participants Initiating Upadacitinib as Combination Therapy (csDMARD +/- Glucocorticoids) and Achieve LDA at 6 months, the Percentage of Participants that Maintain LDA Grouped by Maintenance of Combination Therapy Strategy
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Assessment method [11]
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LDA is defined as DAS28-CRP<3.2.
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Timepoint [11]
0
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Through Month 24
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Secondary outcome [12]
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Of the Participants Initiating Upadacitinib as Monotherapy Therapy (+/- Glucocorticoids) and Achieve Remission at 6 months, the Percentage of Participants that Maintain Remission Grouped by Maintenance of Monotherapy
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Assessment method [12]
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Remission is defined as DAS28-CRP<2.6.
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Timepoint [12]
0
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Through Month 24
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Secondary outcome [13]
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Of the Participants Initiating Upadacitinib as Monotherapy Therapy (+/- Glucocorticoids) and Achieve LDA at 6 months, the Percentage of Participants that Maintain LDA Grouped by Maintenance of Monotherapy
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Assessment method [13]
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LDA is defined as DAS28-CRP<3.2.
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Timepoint [13]
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Through Month 24
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Secondary outcome [14]
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Percentage of Participants Who Do Not Achieve Remission at Any Point in the Study
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Assessment method [14]
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Remission is defined as DAS28-CRP<2.6.
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Timepoint [14]
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Through Month 24
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Secondary outcome [15]
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Time to the Discontinuation of Upadacitinib
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Assessment method [15]
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Time to the discontinuation of Upadacitinib.
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Timepoint [15]
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Through Month 24
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Secondary outcome [16]
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Time to First Treatment Adjustment
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Assessment method [16]
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Treatment Adjustment is defined as treatment escalation/de-escalation/ addition/withdrawal.
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Timepoint [16]
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Baseline (Month 0) Through Month 24
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Secondary outcome [17]
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Percentage of Participants Achieving LDA Grouped by Therapy Strategy
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Assessment method [17]
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LDA is defined as DAS28-CRP<3.2, Simplified Disease Activity Index (SDAI) =11 and Clinical Disease Activity Index (CDAI) =10.
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Timepoint [17]
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Through Month 24
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Secondary outcome [18]
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Percentage of Participants Achieving Remission Grouped by Therapy Strategy
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Assessment method [18]
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Remission is defined as DAS28-CRP<2.6, SDAI=3.3 and CDAI =2.8.
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Timepoint [18]
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Through Month 24
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Secondary outcome [19]
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Change in Medication Burden Treatment Burden Questionnaire (TBQ) in Participants, Grouped by Therapy Strategy
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Assessment method [19]
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The TBQ is composed of 13 items rated on a Likert scale ranging from 0 (not a problem), to 10 (big problem). scores can be summed into a global score, ranging from 0 to 130.
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Timepoint [19]
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Through Week 24
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Secondary outcome [20]
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Change in Physical Function Health Assessment Questionnaire - Disability Index (HAQ-DI) in Participants, Grouped by Therapy Strategy
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Assessment method [20]
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HAQ is a widely accepted, validated, rheumatology specific instrument to assess physical function in Rheumatoid Arthritis. It consists of 20 questions, covering eight types of activities. For each question, scores range from 0 to 3 (0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty or with assistance; 3 = unable to do). HAQ Disability Index (HAQ-DI) score is the average of the highest score in each of the eight categories.
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Timepoint [20]
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Baseline (Month 0) Through Month 24
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Secondary outcome [21]
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Change in Pain Visual Analogue Scale (VAS) in participants, Grouped by Therapy Strategy
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Assessment method [21]
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A VAS is used to assess worst joint pain in the past 7 days.
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Timepoint [21]
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Baseline (Month 0) Through Month 24
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Secondary outcome [22]
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Change in Morning Stiffness in Participants, Grouped by Therapy Strategy
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Assessment method [22]
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A numeric rating scale (NRS) is used to assess severity and length of morning stiffness in the past 7 days.
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Timepoint [22]
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Baseline (Month 0) Through Month 24
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Secondary outcome [23]
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Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) in Participants, Grouped by Therapy Strategy
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Assessment method [23]
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The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four-point Likert scale (0 = not at all fatigued to 4 = very much fatigued).
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Timepoint [23]
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Baseline (Month 0) Through Month 24
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Eligibility
Key inclusion criteria
- Confirmed diagnosis of moderate to severe active Rheumatoid Arthritis (RA).
- Physician decision on patient treatment with upadacitinib must have been reached prior
to and independently of recruitment in the study.
- Upadacitinib prescribed in accordance to the applicable approved label and local
regulatory and reimbursement policies.
- French Participants Only: Taking oral glucocorticoids =5 mg/day of prednisone or
equivalent for at least 3 months prior to study start.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Prior treatment with Upadacitinib.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/10/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/05/2024
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Sample size
Target
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Accrual to date
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Final
1532
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Genesis Research Services /ID# 224060 - Broadmeadow
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Recruitment hospital [2]
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BJC Health /ID# 223884 - Paramatta
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Recruitment hospital [3]
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Private Practice - Scott Walter Graf /ID# 223958 - Adelaide
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Recruitment hospital [4]
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Emeritus Research /ID# 223883 - Camberwell
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Recruitment hospital [5]
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Joint West Rheumatology /ID# 223886 - Murdoch
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Recruitment postcode(s) [1]
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2292 - Broadmeadow
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Recruitment postcode(s) [2]
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2150 - Paramatta
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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3124 - Camberwell
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Recruitment postcode(s) [5]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Buenos Aires
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Country [2]
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Argentina
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State/province [2]
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Ciudad Autonoma De Buenos Aires
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Country [3]
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Argentina
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State/province [3]
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Santa Fe
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Country [4]
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Argentina
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State/province [4]
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Tucuman
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Argentina
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State/province [5]
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Cordoba
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Country [6]
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Argentina
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State/province [6]
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Santiago Del Estero
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Country [7]
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Austria
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State/province [7]
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Kaernten
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Austria
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Niederoesterreich
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Austria
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Steiermark
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Austria
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Wien
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Belgium
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Bruxelles-Capitale
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Belgium
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Hainaut
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Belgium
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Limburg
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Belgium
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Namur
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Belgium
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Oost-Vlaanderen
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Belgium
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Aalst
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Genk
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Allier
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Strasbourg
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0
Germany
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State/province [87]
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Ehringshausen
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Germany
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Erfurt
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Germany
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Gommern
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Leipzig
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Germany
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Leverkusen
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Germany
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Magdeburg
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Germany
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Pfarrkirchen
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Country [96]
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Germany
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Planegg
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Country [97]
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Germany
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Trier
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Greece
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Achaia
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Country [99]
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Greece
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Attiki
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Greece
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Evros
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Greece
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Kriti
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Country [102]
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Greece
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State/province [102]
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Athens
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Country [103]
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Greece
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State/province [103]
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Patras
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Country [104]
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Greece
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Thessaloniki
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Ireland
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Dublin
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Country [106]
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Israel
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H_efa
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Israel
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HaMerkaz
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Israel
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HaTsafon
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Country [109]
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Israel
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Tel-Aviv
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Country [110]
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Israel
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Haifa
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Country [111]
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Italy
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State/province [111]
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Ancona
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Country [112]
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Italy
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State/province [112]
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Ferrara
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Country [113]
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Italy
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Genova
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Country [114]
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Italy
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State/province [114]
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Lazio
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Country [115]
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Italy
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State/province [115]
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Milano
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Country [116]
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Italy
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State/province [116]
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Roma
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Country [117]
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Italy
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Torino
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Country [118]
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Italy
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Alessandria
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Country [119]
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Italy
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Bari
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Country [120]
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Italy
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Bergamo
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Country [121]
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Italy
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Brescia
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Country [122]
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Italy
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State/province [122]
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Chieti
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Country [123]
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Italy
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Milan
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Country [124]
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Italy
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Modena
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Country [125]
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Italy
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Napoli
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Country [126]
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Italy
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Palermo
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Country [127]
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Italy
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State/province [127]
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Pavia
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Country [128]
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Italy
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State/province [128]
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Pisa
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Country [129]
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Italy
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State/province [129]
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Potenza
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Country [130]
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Italy
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State/province [130]
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Rome
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Country [131]
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Italy
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State/province [131]
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Salerno
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Country [132]
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Italy
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State/province [132]
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Siena
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Country [133]
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Italy
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State/province [133]
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Udine
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Country [134]
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0
Italy
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State/province [134]
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Verona
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Country [135]
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0
Kuwait
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Hawalli
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Country [136]
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Kuwait
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State/province [136]
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Kuwait City
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Country [137]
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Kuwait
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State/province [137]
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Kuwait
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Country [138]
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Mexico
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State/province [138]
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Ciudad De Mexico
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Country [139]
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Mexico
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Jalisco
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Country [140]
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Mexico
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Nuevo Leon
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Country [141]
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Mexico
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State/province [141]
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Mexico City
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Country [142]
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Mexico
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State/province [142]
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Puebla
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Country [143]
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Russian Federation
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State/province [143]
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Komi, Respublika
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Country [144]
0
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Russian Federation
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State/province [144]
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Moskovskaya Oblast
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Country [145]
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Russian Federation
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State/province [145]
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Samarskaya Oblast
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Country [146]
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Russian Federation
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Sankt-Peterburg
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Russian Federation
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Tyumenskaya Oblast
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Russian Federation
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Khanty-Mansyisk
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Country [149]
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Russian Federation
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Moscow
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Country [150]
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Russian Federation
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Omsk
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Country [151]
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Russian Federation
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Orenburg
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Country [152]
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Russian Federation
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State/province [152]
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Petrozavodsk
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Country [153]
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Russian Federation
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State/province [153]
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Samara
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Country [154]
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Russian Federation
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State/province [154]
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0
St. Petersburg
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Country [155]
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Russian Federation
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State/province [155]
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Surgut
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Country [156]
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0
Russian Federation
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State/province [156]
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Tomsk
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Country [157]
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0
Russian Federation
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State/province [157]
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0
Ulyanovsk
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Country [158]
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0
Russian Federation
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State/province [158]
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Voronezh
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Country [159]
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Russian Federation
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State/province [159]
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Yaroslavl
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Country [160]
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0
Saudi Arabia
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Jeddah
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Country [161]
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0
Saudi Arabia
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State/province [161]
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0
Mushait
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Country [162]
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0
Saudi Arabia
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State/province [162]
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Riyadh
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Country [163]
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0
Spain
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State/province [163]
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0
A Coruna
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Country [164]
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0
Spain
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State/province [164]
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Badajoz
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Country [165]
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Spain
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Barcelona
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Country [166]
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Spain
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State/province [166]
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Caceres
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Country [167]
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Spain
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State/province [167]
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Cadiz
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Country [168]
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Spain
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State/province [168]
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Cordoba
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Country [169]
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Spain
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State/province [169]
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Madrid
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Country [170]
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Spain
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Murcia
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Country [171]
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Spain
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State/province [171]
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Pontevedra
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Country [172]
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Spain
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State/province [172]
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Santa Cruz De Tenerife
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Country [173]
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Spain
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Zaragoza
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Country [174]
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Spain
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Almeria
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Spain
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Granada
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Country [176]
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Spain
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Huelva
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Country [177]
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Spain
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Jaen
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Spain
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Malaga
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Spain
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Sevilla
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Country [180]
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Switzerland
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Aargau
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Switzerland
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Basel-Stadt
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Switzerland
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Sankt Gallen
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Switzerland
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Thurgau
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Country [184]
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Switzerland
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Vaud
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Switzerland
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Bern
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Switzerland
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Fribourg
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Taiwan
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Taipei
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Country [188]
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Country [190]
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Taiwan
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Tainan
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Country [191]
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Taiwan
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Taipei City
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Country [192]
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Taiwan
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Taoyuan City
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Country [193]
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United Arab Emirates
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State/province [193]
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Abu Dhabi
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Country [194]
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United Arab Emirates
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State/province [194]
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Dubai
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Country [195]
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Uruguay
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State/province [195]
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Montevideo
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness,
swelling and loss of joint function. Despite the range of treatment options for RA steadily
increasing, many patients remain sub-optimally managed, with sustained clinical remission
rarely achieved. This study will assess the treatment patterns, achievement of treatment
targets and maintenance of response.
Upadacitinib is a drug approved for the treatment of moderately to severely active rheumatoid
arthritis. Adult participants with moderate to severe RA who have been prescribed
upadacitinib by their physicians will be enrolled. Approximately, 1660 participants will be
enrolled this study, worldwide.
Participants will not receive Upadacitinib as part of this study, but will be followed for
response to treatment for up to 24 months.
There may be higher burden for participants in this trial compared to their standard of care.
Participants will attend regular visits, every 3 months, during the course of the study at a
hospital or clinic and will be asked to provide additional information by questionnaire at
each visit.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04497597
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
ABBVIE INC.
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Address
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AbbVie
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0
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Phone
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Fax
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04497597
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