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

AbbVie15 sites in 1 country97 target enrollmentMarch 14, 2022

ConditionsRheumatoid Arthritis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: AbbVie
Enrollment: 97
Locations: 15
Primary Endpoint: Percentage of Participants Achieving 28-Joint Disease Activity Score (DAS28) C-reactive protein (CRP) Clinical Remission
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 14, 2022

End Date

January 31, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

AbbVie

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Percentage of Participants Achieving 28-Joint Disease Activity Score (DAS28) C-reactive protein (CRP) Clinical Remission

Time Frame: 6 Months

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. Clinical remission is defined as a DAS28 CRP \<2.6.

Secondary Outcomes

Percentage of Participants Achieving DAS28 CRP Clinical Remission(3 Months)
Percentage of Participants Achieving Boolean Remission(6 Months)
Time to Discontinuation of Upadacitinib(Up to 6 Months)
Number of RA-Related Concomitant Medications Prescribed(Up to 6 Months)
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Clinical Remission(3 Months)
Percentage of Participants Remaining on Treatment(6 Months)
Change from Baseline in Patient Health Questionnaire-2 (PHQ-2) Score(Up to 6 Months)
Percentage of Participants Achieving MCID in FACIT-Fatigue Score(Up to 6 Months)
Percentage of Participants Achieving a Moderate European League Against Rheumatism (EULAR) Response(6 Months)
Percentage of Participants Achieving CDAI Low Disease Activity(6 Months)
Percentage of Participants Achieving CDAI Clinical Remission(6 Months)
Change from Baseline in Fatigue VAS Score(Up to 6 Months)
Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score(Up to 6 Months)
Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Pain VAS(Up to 6 Months)
Percentage of Participants Achieving MCID in PHQ-2 Score(Up to 6 Months)
Percentage of Participants Initiating Upadacitinib as Monotherapy(Baseline)
Percentage of Participants Initiating Upadacitinib in Combination Therapy(Baseline)
Number of Other (Not Rheumatoid Arthritis [RA]-Related) Concomitant Medications Prescribed(Baseline)
Percentage of Participants Achieving DAS28 CRP Low Disease Activity(6 Months)
Percentage of Participants Who Have Received any COVID-19 or Herpes Zoster Vaccination(Up to 6 Months)
Change from Baseline in Pain Visual Analogue Scale (VAS)(Up to 6 Months)
Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score(Up to 6 Months)
Change from Baseline in EQ-5D-5L Score(Up to 6 Months)
Change from Baseline in Work Productivity and Activity Impairment Questionnaire-General Health (WPAI-GH) Score(Up to 6 Months)
Percentage of Participants Achieving MCID in Fatigue VAS Score(Up to 6 Months)
Time to Achieve MCID in FACIT-Fatigue Score(Up to 6 Months)
Percentage of Participants Achieving MCID in HAQ-DI Score(Up to 6 Months)
Time to Achieve MCID in Pain VAS(Up to 6 Months)
Time to Achieve MCID in Fatigue VAS Score(Up to 6 Months)
Time to Achieve MCID in HAQ-DI Score(Up to 6 Months)
Time to Achieve MCID in PHQ-2 Score(Up to 6 Months)