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

Rheumatoid Arthritis Clinical Trial

— ENDEAVOUR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05170646
• Other study ID #: P20-235
• Status: Completed
• Start date: March 14, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United Kingdom	Royal United Hospitals Bath /ID# 251707	Bath
United Kingdom	Cambridge University Hospitals NHS Foundation Trust /ID# 251706	Cambridge
United Kingdom	Medway NHS Foundation Trust /ID# 244673	Gillingham	Kent
United Kingdom	University Hospitals of Morecambe Bay NHS Foundation Trust /ID# 242376	Kendal	Cumbria
United Kingdom	Leicester Royal Infirmary /ID# 244674	Leicester	England
United Kingdom	Liverpool University Hospitals NHS Foundation Trust /ID# 251701	Liverpool
United Kingdom	Guys and St Thomas NHS Foundation Trust /ID# 251704	London	London, City Of
United Kingdom	King's College Hospital NHS Foundation Trust /ID# 251705	London
United Kingdom	Western Health and Social Care Trust /ID# 251702	Londonderry
United Kingdom	Luton and Dunstable Hospital NHS Foundation Trust /ID# 251699	Luton
United Kingdom	Aneurin Bevan University Health Board /ID# 251703	Newport
United Kingdom	Northampton General Hospital NHS Trust /ID# 251710	Northampton	Northamptonshire
United Kingdom	Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 251700	Norwich	Norfolk
United Kingdom	The Royal Wolverhampton NHS Trust /ID# 251708	Wolverhampton
United Kingdom	York and Scarborough Teaching Hospitals NHS Foundation Trust /ID# 244672	York

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving 28-Joint Disease Activity Score (DAS28) C-reactive protein (CRP) Clinical Remission	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.	6 Months
Secondary	Percentage of Participants Achieving a Moderate European League Against Rheumatism (EULAR) Response	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. A moderate EULAR response is defined as a DAS28 CRP >5.1 with a DAS28 CRP decrease >1.2 or DAS 28 CRP score >3.2 and =5.1 with DAS28 CRP decrease >0.6.	6 Months
Secondary	Percentage of Participants Achieving DAS28 CRP Clinical Remission	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.	3 Months
Secondary	Percentage of Participants Achieving DAS28 CRP Low Disease Activity	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. Low disease activity is defined as DAS28 CRP <=3.2.	3 Months
Secondary	Percentage of Participants Achieving DAS28 CRP Low Disease Activity	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. Low disease activity is defined as DAS28 CRP <=3.2.	6 Months
Secondary	Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Clinical Remission	The CDAI is a validated measure of RA disease activity. Scores on the CDAI range from 0 (lowest disease activity) to 76 (highest disease activity). Clinical remission is defined as CDAI <=2.8.	3 Months
Secondary	Percentage of Participants Achieving CDAI Low Disease Activity	The CDAI is a validated measure of RA disease activity. Scores on the CDAI range from 0 (lowest disease activity) to 76 (highest disease activity). Low disease activity is defined as CDAI <=10.	3 Months
Secondary	Percentage of Participants Achieving CDAI Clinical Remission	The CDAI is a validated measure of RA disease activity. Scores on the CDAI range from 0 (lowest disease activity) to 76 (highest disease activity). Clinical remission is defined as CDAI <=2.8.	6 Months
Secondary	Percentage of Participants Achieving CDAI Low Disease Activity	The CDAI is a validated measure of RA disease activity. Scores on the CDAI range from 0 (lowest disease activity) to 76 (highest disease activity). Low disease activity is defined as CDAI <=10.	6 Months
Secondary	Percentage of Participants Achieving Boolean Remission	Boolean remission is achieved when all of the following conditions are satisfied: tender joint count <=1, swollen joint count <=1, CRP <=1 mg/dL, and patient global assessment <=1 (on a 0-10 scale).	3 Months
Secondary	Percentage of Participants Achieving Boolean Remission	Boolean remission is achieved when all of the following conditions are satisfied: tender joint count <=1, swollen joint count <=1, CRP <=1 mg/dL, and patient global assessment <=1 (on a 0-10 scale).	6 Months
Secondary	Percentage of Participants Initiating Upadacitinib as Monotherapy	Percentage of participants initiating upadacitinib without conventional synthetic disease-modifying antirheumatic drugs (csDMARDs).	Baseline
Secondary	Percentage of Participants Initiating Upadacitinib in Combination Therapy	Percentage of participants initiating upadacitinib in combination therapy with csDMARDs.	Baseline
Secondary	Time to Discontinuation of Upadacitinib	Time from initiation to discontinuation of upadacitinib.	Up to 6 Months
Secondary	Percentage of Participants Remaining on Treatment	Percentage of participants remaining on upadacitinib 6 months post initiation.	6 Months
Secondary	Number of Other (Not Rheumatoid Arthritis [RA]-Related) Concomitant Medications Prescribed	Other (not RA-related) concomitant medications include statins and other non-RA-related concomitant medications.	Baseline
Secondary	Number of RA-Related Concomitant Medications Prescribed	RA-related concomitant medications include csDMARDS, corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), other painkillers, and other RA-related concomitant medications.	Up to 6 Months
Secondary	Percentage of Participants Who Have Received any COVID-19 or Herpes Zoster Vaccination	Percentage of participants who have received any COVID-19 or Herpes Zoster vaccination and a summary of vaccination details.	Up to 6 Months
Secondary	Change from Baseline in Pain Visual Analogue Scale (VAS)	The patient's level of pain in the last 24 hours will be measured using a pain VAS. VAS scores range from 0 to 100 points with a higher score indicating more pain.	Up to 6 Months
Secondary	Change from Baseline in Fatigue VAS Score	A fatigue VAS will be used to assess the patient's level of fatigue on a weekly basis. VAS scores range from 0 to 100 points with a higher score indicating more fatigue.	Up to 6 Months
Secondary	Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score	The FACIT-Fatigue Scale measures an individual's level of fatigue during their usual daily activities over the past week. on a four-point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The score range for FACIT-Fatigue is between 0 and 52. A score of less than 30 indicates severe fatigue. The higher the score, the better the quality of life.	Up to 6 Months
Secondary	Change from Baseline in Patient Health Questionnaire-2 (PHQ-2) Score	The PHQ-2 screens for the presence of possible depression. The PHQ-2 inquires about the frequency of depressed mood and anhedonia over the past 2 weeks, scoring each component from 0 ("not at all") to 3 ("nearly every day").	Up to 6 Months
Secondary	Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score	The HAQ-DI assesses physical function in RA. The HAQ-DI score is the average of the highest score in each of eight categories. The total score is between 0-3.0, in 0.125 increments. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment	Up to 6 Months
Secondary	Change from Baseline in EQ-5D-5L Score	The EQ-5D-5L comprises of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. In addition, a vertical VAS is used to assess patient's self-rated health status. The endpoints for the VAS are labelled 'the best health you can imagine' and 'the worst health you can imagine'. The recall period is one day.	Up to 6 Months
Secondary	Change from Baseline in Work Productivity and Activity Impairment Questionnaire-General Health (WPAI-GH) Score	The WPAI-GH measures the impact of health problems on absenteeism, presenteeism, overall work performance and non-work activities using a 0 to 10 VAS.	Up to 6 Months
Secondary	Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Pain VAS	The patient's level of pain in the last 24 hours will be measured using a pain VAS. VAS scores range from 0 to 100 points with a higher score indicating more pain. MCID is defined as at least a 10 point difference from baseline.	Up to 6 Months
Secondary	Percentage of Participants Achieving MCID in Fatigue VAS Score	A fatigue VAS will be used to assess the patient's level of fatigue on a weekly basis. VAS scores range from 0 to 100 points with a higher score indicating more fatigue. MCID is defined as a decrease of -1.12.	Up to 6 Months
Secondary	Percentage of Participants Achieving MCID in FACIT-Fatigue Score	The FACIT-Fatigue Scale measures an individual's level of fatigue during their usual daily activities over the past week. on a four-point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The score range for FACIT-Fatigue is between 0 and 52. A score of less than 30 indicates severe fatigue. The higher the score, the better the quality of life. MCID is defined as a 4-point increase.	Up to 6 Months
Secondary	Percentage of Participants Achieving MCID in PHQ-2 Score	The PHQ-2 screens for the presence of possible depression. The PHQ-2 inquires about the frequency of depressed mood and anhedonia over the past 2 weeks, scoring each component from 0 ("not at all") to 3 ("nearly every day"). MCID is defined as achievement of a PHQ-2 score <=2 and absence of low mood.	Up to 6 Months
Secondary	Percentage of Participants Achieving MCID in HAQ-DI Score	The HAQ-DI assesses physical function in RA. The HAQ-DI score is the average of the highest score in each of eight categories. The total score is between 0-3.0, in 0.125 increments. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment. MCID is defined as decrease of -0.22.	Up to 6 Months
Secondary	Time to Achieve MCID in FACIT-Fatigue Score	The FACIT-Fatigue Scale measures an individual's level of fatigue during their usual daily activities over the past week. on a four-point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The score range for FACIT-Fatigue is between 0 and 52. A score of less than 30 indicates severe fatigue. The higher the score, the better the quality of life. MCID is defined as a 4-point increase.	Up to 6 Months
Secondary	Time to Achieve MCID in Pain VAS	The patient's level of pain in the last 24 hours will be measured using a pain VAS. VAS scores range from 0 to 100 points with a higher score indicating more pain. MCID is defined as at least a 10 point difference from baseline.	Up to 6 Months
Secondary	Time to Achieve MCID in Fatigue VAS Score	A fatigue VAS will be used to assess the patient's level of fatigue on a weekly basis. VAS scores range from 0 to 100 points with a higher score indicating more fatigue. MCID is defined as a decrease of -1.12.	Up to 6 Months
Secondary	Time to Achieve MCID in PHQ-2 Score	The PHQ-2 screens for the presence of possible depression. The PHQ-2 inquires about the frequency of depressed mood and anhedonia over the past 2 weeks, scoring each component from 0 ("not at all") to 3 ("nearly every day"). MCID is defined as achievement of a PHQ-2 score <=2 and absence of low mood.	Up to 6 Months
Secondary	Time to Achieve MCID in HAQ-DI Score	The HAQ-DI assesses physical function in RA. The HAQ-DI score is the average of the highest score in each of eight categories. The total score is between 0-3.0, in 0.125 increments. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment. MCID is defined as decrease of -0.22.	Up to 6 Months

External Links

•   Related Info