An Observational Study to Assess the Real-World Effectiveness of Upadacitinib in Adult Participants With Rheumatoid Arthritis

Real World Clinical and Patient-Reported Outcomes of Patients With Moderate-to-Severe Rheumatoid Arthritis Initiating Upadacitinib in the United Kingdom: A Prospective, Observational Cohort Study

Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. RA can reduce the ability to perform everyday tasks. This study will assess the clinical and patient-reported outcomes with upadacitinib in adult participants with moderate-to-severe RA in a real-world setting.

Upadacitinib is an approved drug for the treatment of adults with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate. Adult participants with moderate-to-severe RA will be enrolled. Around 150 participants will be enrolled in the study in multiple sites in the United Kingdom.

Participants will receive upadacitinib per their physician's usual prescription. Individual data will be collected for 6 months.

No additional study-related tests will be conducted during the routine physician visits. Only data which are routinely collected during a regular visit will be utilized for this study.

Inclusion Criteria:

• American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) confirmed diagnosis of rheumatoid arthritis (RA).
• Moderate RA (defined by National Institute for Health and Care Excellence [NICE] as 28-joint Disease Activity Score [DAS28] C-reactive protein [CRP] >3.2 and ≤5.1) or severe RA (defined by NICE as DAS28 CRP >5.1) at the time of enrollment.
• Prescribed upadacitinib in line with marketing authorization.
• Decision to treat with upadacitinib has been made independently and prior to enrolment in the study.
• Able to read and understand English.
• Willing and able to participate in the collection of patient-reported data via mobile app.

Exclusion Criteria:

• First dose of upadacitinib received prior to enrollment in the study (same day permitted) or more than 28 days after enrolment into the study.
• Previously received >4 biologic disease-modifying antirheumatic drugs (bDMARD) (1 switch to a biosimilar for non-clinical reasons is allowed for each bDMARD received) or any Janus kinase (JAK) inhibitor for the treatment of RA.
• In the opinion of the treating clinician, participant symptoms are predominately being driven by fibromyalgia or unrelated pain component instead of underlying inflammatory disease.
• Participation in any interventional clinical trial within the 3 months prior to initiation or at any point during the study observation period.