An observational study in Rheumatoid Arthritis (RA), sponsored by AbbVie. Completed at 263 sites in 19 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-13.
Sponsored by AbbVie · Observational
Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. Despite the range of treatment options for RA steadily increasing, many patients remain sub-optimally managed, with sustained clinical remission rarely achieved. This study will assess the treatment patterns, achievement of treatment targets and maintenance of response.
Upadacitinib is a drug approved for the treatment of moderately to severely active rheumatoid arthritis. Adult participants with moderate to severe RA who have been prescribed upadacitinib by their physicians will be enrolled. Approximately, 1660 participants will be enrolled this study, worldwide.
Participants will not receive Upadacitinib as part of this study, but will be followed for response to treatment for up to 24 months.
There may be higher burden for participants in this trial compared to their standard of care. Participants will attend regular visits, every 3 months, during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's enrollment of 1,532 is above the median of 176 across 1,016 observational studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adults receiving Upadacitinib according to the product prescribing information, for moderate to severe active Rheumatoid Arthritis (RA).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receiving Upadacitinib for moderate to severe rheumatoid arthritis (RA).
Percentage of Participants Who Achieve Remission
Remission is defined as Disease Activity Score at 28 joints (DAS28) C-reactive Protein (CRP)\<2.6.
Time frame: At Month 6
Percentage of Participants Who Achieve Remission at 6 Months and Maintain Remission
Remission is defined as DAS28-CRP\<2.6. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.
Time frame: At Month 12
Percentage of Participants Who Achieve Remission at 6 Months and Maintain Remission
Remission is defined as DAS28-CRP\<2.6. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.
Time frame: At Month 24
Percentage of Participants Who Achieve Low Disease Activity (LDA) at 6 months that maintain LDA
LDA is defined as DAS28-CRP≤3.2. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.
Time frame: Through Month 24
Percentage of Participants Who Achieve Remission at 3 Months and Maintain Remission
Remission is defined as DAS28-CRP\<2.6. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.
Time frame: Through Month 24
Percentage of Participants Who Achieve Remission at 6 Months and Maintain Remission Grouped by Glucocorticoid Dose
Remission is defined as DAS28-CRP\<2.6. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.
Time frame: At Month 12
Percentage of Participants Who Achieve LDA at 3 months that maintain LDA Grouped by Glucocorticoid Dose
LDA is defined as DAS28-CRP≤3.2. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.
Time frame: Through Month 6
Percentage of Participants in LDA that Achieve Glucocorticoid Dose <5 mg/Day Per Visit
LDA is defined as DAS28-CRP\<3.2.
Time frame: Through Month 24
Percentage of Participants in Remission that Achieve Glucocorticoid Dose <5 mg/Day Per Visit
Remission is defined as DAS28-CRP\<2.6.
Time frame: Through Month 24
Percentage of Participants Who Achieved a Glucocorticoid Dose <5 mg/Day Without Conventional Synthetic Disease Modifying Anti Rheumatic Drug (csDMARD) Intensification
Percentage of participants who achieved a glucocorticoid dose \<5 mg/day without csDMARD intensification.
Time frame: At Month 6
Percentage of Participants Who Initiated Upadacitinib as Combination Therapy (csDMARD +/- Glucocorticoids) That Moved to Monotherapy (+/- Glucocorticoids)
Percentage of participants who initiated Upadacitinib as combination therapy (csDMARD +/- Glucocorticoids) that moved to monotherapy (+/- glucocorticoids).
Time frame: Through Week 24
Of the Participants Initiating Upadacitinib as Combination Therapy (csDMARD +/- Glucocorticoids) and Achieve Remission at 6 months, the Percentage of Participants that Maintain Remission Grouped by Maintenance of Combination Therapy Strategy
Remission is defined as DAS28-CRP\<2.6.
Time frame: Through Month 24
Of the Participants Initiating Upadacitinib as Combination Therapy (csDMARD +/- Glucocorticoids) and Achieve LDA at 6 months, the Percentage of Participants that Maintain LDA Grouped by Maintenance of Combination Therapy Strategy
LDA is defined as DAS28-CRP\<3.2.
Time frame: Through Month 24
Of the Participants Initiating Upadacitinib as Monotherapy Therapy (+/- Glucocorticoids) and Achieve Remission at 6 months, the Percentage of Participants that Maintain Remission Grouped by Maintenance of Monotherapy
Remission is defined as DAS28-CRP\<2.6.
Time frame: Through Month 24
Of the Participants Initiating Upadacitinib as Monotherapy Therapy (+/- Glucocorticoids) and Achieve LDA at 6 months, the Percentage of Participants that Maintain LDA Grouped by Maintenance of Monotherapy
LDA is defined as DAS28-CRP\<3.2.
Time frame: Through Month 24
Percentage of Participants Who Do Not Achieve Remission at Any Point in the Study
Remission is defined as DAS28-CRP\<2.6.
Time frame: Through Month 24
Time to the Discontinuation of Upadacitinib
Time to the discontinuation of Upadacitinib.
Time frame: Through Month 24
Time to First Treatment Adjustment
Treatment Adjustment is defined as treatment escalation/de-escalation/ addition/withdrawal.
Time frame: Baseline (Month 0) Through Month 24
Percentage of Participants Achieving LDA Grouped by Therapy Strategy
LDA is defined as DAS28-CRP\<3.2, Simplified Disease Activity Index (SDAI) ≤11 and Clinical Disease Activity Index (CDAI) ≤10.
Time frame: Through Month 24
Percentage of Participants Achieving Remission Grouped by Therapy Strategy
Remission is defined as DAS28-CRP\<2.6, SDAI≤3.3 and CDAI ≤2.8.
Time frame: Through Month 24
Change in Medication Burden Treatment Burden Questionnaire (TBQ) in Participants, Grouped by Therapy Strategy
The TBQ is composed of 13 items rated on a Likert scale ranging from 0 (not a problem), to 10 (big problem). scores can be summed into a global score, ranging from 0 to 130.
Time frame: Through Week 24
Change in Physical Function Health Assessment Questionnaire - Disability Index (HAQ-DI) in Participants, Grouped by Therapy Strategy
HAQ is a widely accepted, validated, rheumatology specific instrument to assess physical function in Rheumatoid Arthritis. It consists of 20 questions, covering eight types of activities. For each question, scores range from 0 to 3 (0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty or with assistance; 3 = unable to do). HAQ Disability Index (HAQ-DI) score is the average of the highest score in each of the eight categories.
Time frame: Baseline (Month 0) Through Month 24
Change in Pain Visual Analogue Scale (VAS) in participants, Grouped by Therapy Strategy
A VAS is used to assess worst joint pain in the past 7 days.
Time frame: Baseline (Month 0) Through Month 24
Change in Morning Stiffness in Participants, Grouped by Therapy Strategy
A numeric rating scale (NRS) is used to assess severity and length of morning stiffness in the past 7 days.
Time frame: Baseline (Month 0) Through Month 24
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) in Participants, Grouped by Therapy Strategy
The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four-point Likert scale (0 = not at all fatigued to 4 = very much fatigued).
Time frame: Baseline (Month 0) Through Month 24
Showing the first 100 of 263 sites across 19 countries. Choose a country and city above to see the rest.
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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