A Study of Oral Upadacitinib Tablets to Assess the Change in Disease Symptoms in Adult Canadian Participants With Moderate to Severe Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. This study will assess how effective Upadacitinib is in changing the disease symptoms in Canadian participants with RA. Upadacitinib is a drug approved for the treatment of moderately to severely active rheumatoid arthritis. Adult Canadian participants with moderate to severe RA who have been prescribed upadacitinib by their physicians will be enrolled. Approximately, 390 participants will be enrolled this study, in multiple sites within Canada. Participants will receive Upadacitinib as prescribed by the physician and will be followed for approximately 24 months. There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits 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
-----------------
Canadian Real-life Post-marketing Observational Study Assessing the Effectiveness of Upadacitinib for Treating Rheumatoid Arthritis (CLOSEUP)

Conditions
-----------------
Rheumatoid Arthritis (RA)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of moderate to severe Rheumatoid Arthritis (RA) according to the investigator. Decision to initiate UPA treatment by investigator according to the local product label independent of the participant's participation in the study. Has been previously treated with Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) and corresponds to one of the following subgroups: Has not been previously exposed to any Biologic Disease-Modifying Antirheumatic Drugs (bDMARD) or Targeted Synthetic Disease-Modifying Antirheumatic Drugs (tsDMARD). Has not been previously exposed to tsDMARD and has been previously exposed to <= 2 bDMARDs. Has been previously treated with one tsDMARD and <=1 bDMARD prior to treatment with that tsDMARD. Exclusion Criteria: Presence of any condition that, in the opinion of the treating physician, prohibits the participant from participating in the study or obscures the assessment of the treatment of RA. Diagnosis of rheumatic disease other than RA. Diagnosis of juvenile RA. Currently participating in an investigational clinical trial. Has prior exposure to a bDMARD after exposure to a tsDMARD. Has prior exposure to tsDMARD in an investigational clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Achieve Clinical Remission | Clinical remission is defined as Disease Activity Score at 28 joints (DAS28) C-reactive Protein (CRP)<2.6. | At Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Using Visual Analogue Scale (VAS) | Pain is defined using VAS, where a higher score indicates worse pain. | Baseline (Month 0) Through Month 24 | 
| Duration of Morning Stiffness | Duration of morning joint stiffness is defined using VAS, where a higher score indicates worse joint stiffness. | Baseline (Month 0) Through Month 24 | 
| Severity of Morning Stiffness | Severity of morning joint stiffness is defined using VAS, where a higher score indicates worse joint stiffness. | Baseline (Month 0) Through Month 24 | 
| Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) | 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 | 
| Percentage of Participants Achieving Clinical Remission | Clinical Remission is defined as DAS28-CRP<2.6, Simplified Disease Activity Index (SDAI) ≤3.3, Clinical Disease Activity Index (CDAI) ≤2.8, American College of Rheumatology (ACR)-European League Against Rheumatism (EULAR) Boolean remission. | Baseline (Month 0) Through Month 24 | 
| Percentage of Participants Achieving Low Disease Activity (LDA) | LDA is defined as DAS28-CRP<3.2, SDAI ≤11, CDAI ≤10. | Baseline (Month 0) Through Month 24 | 
| Earliest Date When a Response to Treatment is Known to Have Occurred | Earliest date when a response to treatment is known to have occurred. | Baseline (Month 0) Through Month 24 | 
| Earliest Date When Their RA is Known to have Returned (In those Participants who Achieve a Response to Treatment) | Earliest date when their RA is known to have returned (In those participants who achieve a response to treatment). | Through Month 24 | 
| Change in DAS28-CRP Score | The DAS28-CRP used to evaluate disease activity in participants with RA, where worsening RA activity is defined by a higher score. | Baseline (Month 0) Through Month 24 | 
| Change in CDAI Score | The CDAI is used to evaluate disease activity in participants with RA , where worsening RA activity is defined by a higher score. | Baseline (Month 0) Through Month 24 | 
| Change in Tender Joint Count | Change in Tender Joint Count. | Baseline (Month 0) Through Month 24 | 
| Change in Swollen Joint Count | Change in Swollen Joint Count. | Baseline (Month 0) Through Month 24 | 
| Change in Physical Function (HAQ-DI) Score | The HAQ DI is a questionnaire that determines physical function. | Baseline (Month 0) Through Month 24 | 
| Change in Patient Assessment of Global Disease Activity (PtGA) | The PtGA is a outcome instrument to assess the participant's assessment of disease severity. | Baseline (Month 0) Through Month 24 | 
| Change in Physician Assessment of Global Disease Activity (PGA) | The PGA is a outcome instrument to assess the participant's assessment of disease severity. | Baseline (Month 0) Through Month 24 | 
| Percentage of Participants Who Discontinue Upadacitinib | Percentage of participants who discontinue Upadacitinib. | Through Month 24 | 
| Time of Discontinuation from Upadacitinib Initiation Date | Time of discontinuation from Upadacitinib initiation date. | Through Month 24 | 
| Reasons for Upadacitinib Treatment Discontinuation | Reasons for Upadacitinib treatment discontinuation. | Through Month 24 | 
| Immediate Change in RA Medications Following Discontinuation of Upadacitinib | Immediate change in RA medications following discontinuation of Upadacitinib. | Through Month 24 | 
| Percentage of Participants Who Achieve Sustained Remission Following Discontinuation of Upadacitinib | Clinical remission is defined as DAS28 and CRP<2.6. | Through Month 24 | 

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