An observational study in Rheumatoid Arthritis, sponsored by AbbVie. Completed at 15 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by AbbVie · Observational
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 97 is below the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult Participants with moderate-to-severe rheumatoid arthritis (RA)
Exclusion Criteria:
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.
Time frame: 6 Months
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.
Time frame: 6 Months
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.
Time frame: 3 Months
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.
Time frame: 3 Months
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.
Time frame: 6 Months
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.
Time frame: 3 Months
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.
Time frame: 3 Months
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.
Time frame: 6 Months
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.
Time frame: 6 Months
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).
Time frame: 3 Months
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).
Time frame: 6 Months
Percentage of Participants Initiating Upadacitinib as Monotherapy
Percentage of participants initiating upadacitinib without conventional synthetic disease-modifying antirheumatic drugs (csDMARDs).
Time frame: Baseline
Percentage of Participants Initiating Upadacitinib in Combination Therapy
Percentage of participants initiating upadacitinib in combination therapy with csDMARDs.
Time frame: Baseline
Time to Discontinuation of Upadacitinib
Time from initiation to discontinuation of upadacitinib.
Time frame: Up to 6 Months
Percentage of Participants Remaining on Treatment
Percentage of participants remaining on upadacitinib 6 months post initiation.
Time frame: 6 Months
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.
Time frame: Baseline
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.
Time frame: Up to 6 Months
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.
Time frame: Up to 6 Months
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.
Time frame: Up to 6 Months
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.
Time frame: Up to 6 Months
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.
Time frame: Up to 6 Months
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").
Time frame: Up to 6 Months
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
Time frame: Up to 6 Months
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.
Time frame: Up to 6 Months
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.
Time frame: Up to 6 Months
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.
Time frame: Up to 6 Months
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.
Time frame: Up to 6 Months
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.
Time frame: Up to 6 Months
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.
Time frame: Up to 6 Months
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.
Time frame: Up to 6 Months
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.
Time frame: Up to 6 Months
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.
Time frame: Up to 6 Months
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.
Time frame: Up to 6 Months
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.
Time frame: Up to 6 Months
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.
Time frame: Up to 6 Months
Plan to share: Undecided
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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