Clinical trial NCT05170646: An Observational Study to Assess the Real-World Effectiveness of Upadacitinib in Adult Participants With Rheumatoid Arthritis
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis (RA)
Upadacitinib
RINVOQ
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-12-28
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Participants with moderate-to-severe rheumatoid arthritis (RA)

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.


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.

Primary outcomes:
measure: Percentage of Participants Achieving 28-Joint Disease Activity Score (DAS28) C-reactive protein (CRP) Clinical Remission
timeFrame: 6 Months
Secondary outcomes:
measure: Percentage of Participants Achieving a Moderate European League Against Rheumatism (EULAR) Response
timeFrame: 6 Months
measure: Percentage of Participants Achieving DAS28 CRP Clinical Remission
timeFrame: 3 Months
measure: Percentage of Participants Achieving DAS28 CRP Low Disease Activity
timeFrame: 3 Months
measure: Percentage of Participants Achieving DAS28 CRP Low Disease Activity
timeFrame: 6 Months
measure: Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Clinical Remission
timeFrame: 3 Months
measure: Percentage of Participants Achieving CDAI Low Disease Activity
timeFrame: 3 Months
measure: Percentage of Participants Achieving CDAI Clinical Remission
timeFrame: 6 Months
measure: Percentage of Participants Achieving CDAI Low Disease Activity
timeFrame: 6 Months
measure: Percentage of Participants Achieving Boolean Remission
timeFrame: 3 Months
measure: Percentage of Participants Achieving Boolean Remission
timeFrame: 6 Months
measure: Percentage of Participants Initiating Upadacitinib as Monotherapy
timeFrame: Baseline
measure: Percentage of Participants Initiating Upadacitinib in Combination Therapy
timeFrame: Baseline
measure: Time to Discontinuation of Upadacitinib
timeFrame: Up to 6 Months
measure: Percentage of Participants Remaining on Treatment
timeFrame: 6 Months
measure: Number of Other (Not Rheumatoid Arthritis [RA]-Related) Concomitant Medications Prescribed
timeFrame: Baseline
measure: Number of RA-Related Concomitant Medications Prescribed
timeFrame: Up to 6 Months
measure: Percentage of Participants Who Have Received any COVID-19 or Herpes Zoster Vaccination
timeFrame: Up to 6 Months
measure: Change from Baseline in Pain Visual Analogue Scale (VAS)
timeFrame: Up to 6 Months
measure: Change from Baseline in Fatigue VAS Score
timeFrame: Up to 6 Months
measure: Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score
timeFrame: Up to 6 Months
measure: Change from Baseline in Patient Health Questionnaire-2 (PHQ-2) Score
timeFrame: Up to 6 Months
measure: Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
timeFrame: Up to 6 Months
measure: Change from Baseline in EQ-5D-5L Score
timeFrame: Up to 6 Months
measure: Change from Baseline in Work Productivity and Activity Impairment Questionnaire-General Health (WPAI-GH) Score
timeFrame: Up to 6 Months
measure: Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Pain VAS
timeFrame: Up to 6 Months
measure: Percentage of Participants Achieving MCID in Fatigue VAS Score
timeFrame: Up to 6 Months
measure: Percentage of Participants Achieving MCID in FACIT-Fatigue Score
timeFrame: Up to 6 Months
measure: Percentage of Participants Achieving MCID in PHQ-2 Score
timeFrame: Up to 6 Months
measure: Percentage of Participants Achieving MCID in HAQ-DI Score
timeFrame: Up to 6 Months
measure: Time to Achieve MCID in FACIT-Fatigue Score
timeFrame: Up to 6 Months
measure: Time to Achieve MCID in Pain VAS
timeFrame: Up to 6 Months
measure: Time to Achieve MCID in Fatigue VAS Score
timeFrame: Up to 6 Months
measure: Time to Achieve MCID in PHQ-2 Score
timeFrame: Up to 6 Months
measure: Time to Achieve MCID in HAQ-DI Score
timeFrame: Up to 6 Months
Other outcomes:
Locations:
city: Kendal
country: United Kingdom
facility: University Hospitals of Morecambe Bay NHS Foundation Trust /ID# 242376
state: Cumbria
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary /ID# 244674
state: England
city: Gillingham
country: United Kingdom
facility: Medway NHS Foundation Trust /ID# 244673
state: Kent
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust /ID# 251704
state: London, City Of
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 251700
state: Norfolk
city: Northampton
country: United Kingdom
facility: Northampton General Hospital NHS Trust /ID# 251710
state: Northamptonshire
city: Bath
country: United Kingdom
facility: Royal United Hospitals Bath /ID# 251707
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust /ID# 251706
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals NHS Foundation Trust /ID# 251701
city: Londonderry
country: United Kingdom
facility: Western Health and Social Care Trust /ID# 251702
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust /ID# 251705
city: Luton
country: United Kingdom
facility: Luton and Dunstable Hospital NHS Foundation Trust /ID# 251699
city: Newport
country: United Kingdom
facility: Aneurin Bevan University Health Board /ID# 251703
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton NHS Trust /ID# 251708
city: York
country: United Kingdom
facility: York and Scarborough Teaching Hospitals NHS Foundation Trust /ID# 244672
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: