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

Study Overview
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Brief Summary
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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.

Official Title
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Upadacitinib Treatment Patterns, Achievement of Treatment Targets and Maintenance of Response in Moderate to Severe Rheumatoid Arthritis Patients in Real-World Practice (UPHOLD)

Conditions
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Rheumatoid Arthritis (RA)

Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: - Prior treatment with Upadacitinib.

Ages Eligible for Study
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Minimum Age: 18 Years


Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants receiving Upadacitinib<br>Participants receiving Upadacitinib for moderate to severe rheumatoid arthritis (RA). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Achieve Remission | Remission is defined as Disease Activity Score at 28 joints (DAS28) C-reactive Protein (CRP)<2.6. | At Month 6 | 
| Percentage of Participants Who Achieve Remission at 6 Months and Maintain Remission | Remission is defined as DAS28-CRP<2.6. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP. | At Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Achieve Remission at 6 Months and Maintain Remission | Remission is defined as DAS28-CRP<2.6. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP. | At Month 24 | 
| Percentage of Participants Who Achieve Low Disease Activity (LDA) at 6 months that maintain LDA | LDA is defined as DAS28-CRP≤3.2. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP. | Through Month 24 | 
| Percentage of Participants Who Achieve Remission at 3 Months and Maintain Remission | Remission is defined as DAS28-CRP<2.6. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP. | Through Month 24 | 
| Percentage of Participants Who Achieve Remission at 6 Months and Maintain Remission Grouped by Glucocorticoid Dose | Remission is defined as DAS28-CRP<2.6. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP. | At Month 12 | 
| Percentage of Participants Who Achieve LDA at 3 months that maintain LDA Grouped by Glucocorticoid Dose | LDA is defined as DAS28-CRP≤3.2. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP. | Through Month 6 | 
| Percentage of Participants in LDA that Achieve Glucocorticoid Dose <5 mg/Day Per Visit | LDA is defined as DAS28-CRP<3.2. | Through Month 24 | 
| Percentage of Participants in Remission that Achieve Glucocorticoid Dose <5 mg/Day Per Visit | Remission is defined as DAS28-CRP<2.6. | Through Month 24 | 
| Percentage of Participants Who Achieved a Glucocorticoid Dose <5 mg/Day Without Conventional Synthetic Disease Modifying Anti Rheumatic Drug (csDMARD) Intensification | Percentage of participants who achieved a glucocorticoid dose <5 mg/day without csDMARD intensification. | At Month 6 | 
| Percentage of Participants Who Initiated Upadacitinib as Combination Therapy (csDMARD +/- Glucocorticoids) That Moved to Monotherapy (+/- Glucocorticoids) | Percentage of participants who initiated Upadacitinib as combination therapy (csDMARD +/- Glucocorticoids) that moved to monotherapy (+/- glucocorticoids). | Through Week 24 | 
| 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 | Remission is defined as DAS28-CRP<2.6. | Through Month 24 | 
| 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 | LDA is defined as DAS28-CRP<3.2. | Through Month 24 | 
| 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 | Remission is defined as DAS28-CRP<2.6. | Through Month 24 | 
| 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 | LDA is defined as DAS28-CRP<3.2. | Through Month 24 | 
| Percentage of Participants Who Do Not Achieve Remission at Any Point in the Study | Remission is defined as DAS28-CRP<2.6. | Through Month 24 | 
| Time to the Discontinuation of Upadacitinib | Time to the discontinuation of Upadacitinib. | Through Month 24 | 
| Time to First Treatment Adjustment | Treatment Adjustment is defined as treatment escalation/de-escalation/ addition/withdrawal. | Baseline (Month 0) Through Month 24 | 
| Percentage of Participants Achieving LDA Grouped by Therapy Strategy | LDA is defined as DAS28-CRP<3.2, Simplified Disease Activity Index (SDAI) ≤11 and Clinical Disease Activity Index (CDAI) ≤10. | Through Month 24 | 
| Percentage of Participants Achieving Remission Grouped by Therapy Strategy | Remission is defined as DAS28-CRP<2.6, SDAI≤3.3 and CDAI ≤2.8. | Through Month 24 | 
| Change in Medication Burden Treatment Burden Questionnaire (TBQ) in Participants, Grouped by Therapy Strategy | 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. | Through Week 24 | 
| Change in Physical Function Health Assessment Questionnaire - Disability Index (HAQ-DI) in Participants, Grouped by Therapy Strategy | 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. | Baseline (Month 0) Through Month 24 | 
| Change in Pain Visual Analogue Scale (VAS) in participants, Grouped by Therapy Strategy | A VAS is used to assess worst joint pain in the past 7 days. | Baseline (Month 0) Through Month 24 | 
| Change in Morning Stiffness in Participants, Grouped by Therapy Strategy | A numeric rating scale (NRS) is used to assess severity and length of morning stiffness in the past 7 days. | Baseline (Month 0) Through Month 24 | 
| Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) in Participants, Grouped by Therapy Strategy | 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). | Baseline (Month 0) Through Month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis, Upadacitinib, RINVOQ