A Study of Oral Upadacitinib Tablets to Assess Treatment Patterns, Achievement of Treatment Targets and Maintenance of Response in Adult Participants With Moderate to Severe Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis (RA)
- Registration Number
- NCT04497597
- Lead Sponsor
- AbbVie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1532
- Confirmed diagnosis of moderate to severe active Rheumatoid Arthritis (RA).
- Physician decision on patient treatment with upadacitinib must have been reached prior to and independently of recruitment in the study.
- Upadacitinib prescribed in accordance to the applicable approved label and local regulatory and reimbursement policies.
- French Participants Only: Taking oral glucocorticoids ≥5 mg/day of prednisone or equivalent for at least 3 months prior to study start.
- Prior treatment with Upadacitinib.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Achieve Remission at 6 Months and Maintain Remission At Month 12 Remission is defined as DAS28-CRP\<2.6. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.
Percentage of Participants Who Achieve Remission At Month 6 Remission is defined as Disease Activity Score at 28 joints (DAS28) C-reactive Protein (CRP)\<2.6.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Achieved a Glucocorticoid Dose <5 mg/Day Without Conventional Synthetic Disease Modifying Anti Rheumatic Drug (csDMARD) Intensification At Month 6 Percentage of participants who achieved a glucocorticoid dose \<5 mg/day without csDMARD intensification.
Percentage of Participants Who Achieve Remission at 6 Months and Maintain Remission At Month 24 Remission is defined as DAS28-CRP\<2.6. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.
Percentage of Participants Who Achieve Remission at 3 Months and Maintain Remission Through Month 24 Remission is defined as DAS28-CRP\<2.6. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.
Percentage of Participants in Remission that Achieve Glucocorticoid Dose <5 mg/Day Per Visit Through Month 24 Remission is defined as DAS28-CRP\<2.6.
Percentage of Participants Who Achieve LDA at 3 months that maintain LDA Grouped by Glucocorticoid Dose Through Month 6 LDA is defined as DAS28-CRP≤3.2. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.
Percentage of Participants Who Do Not Achieve Remission at Any Point in the Study Through Month 24 Remission is defined as DAS28-CRP\<2.6.
Time to the Discontinuation of Upadacitinib Through Month 24 Time to the discontinuation of Upadacitinib.
Time to First Treatment Adjustment Baseline (Month 0) Through Month 24 Treatment Adjustment is defined as treatment escalation/de-escalation/ addition/withdrawal.
Percentage of Participants Achieving LDA Grouped by Therapy Strategy Through Month 24 LDA is defined as DAS28-CRP\<3.2, Simplified Disease Activity Index (SDAI) ≤11 and Clinical Disease Activity Index (CDAI) ≤10.
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) in Participants, Grouped by Therapy Strategy Baseline (Month 0) Through Month 24 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).
Percentage of Participants Who Achieve Low Disease Activity (LDA) at 6 months that maintain LDA Through Month 24 LDA is defined as DAS28-CRP≤3.2. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.
Percentage of Participants Who Achieve Remission at 6 Months and Maintain Remission Grouped by Glucocorticoid Dose At Month 12 Remission is defined as DAS28-CRP\<2.6. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.
Percentage of Participants Who Initiated Upadacitinib as Combination Therapy (csDMARD +/- Glucocorticoids) That Moved to Monotherapy (+/- Glucocorticoids) Through Week 24 Percentage of participants who initiated Upadacitinib as combination therapy (csDMARD +/- Glucocorticoids) that moved to monotherapy (+/- glucocorticoids).
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 Through Month 24 Remission is defined as DAS28-CRP\<2.6.
Change in Pain Visual Analogue Scale (VAS) in participants, Grouped by Therapy Strategy Baseline (Month 0) Through Month 24 A VAS is used to assess worst joint pain in the past 7 days.
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 Through Month 24 Remission is defined as DAS28-CRP\<2.6.
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 Through Month 24 LDA is defined as DAS28-CRP\<3.2.
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 Through Month 24 LDA is defined as DAS28-CRP\<3.2.
Percentage of Participants Achieving Remission Grouped by Therapy Strategy Through Month 24 Remission is defined as DAS28-CRP\<2.6, SDAI≤3.3 and CDAI ≤2.8.
Change in Medication Burden Treatment Burden Questionnaire (TBQ) in Participants, Grouped by Therapy Strategy Through Week 24 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.
Change in Physical Function Health Assessment Questionnaire - Disability Index (HAQ-DI) in Participants, Grouped by Therapy Strategy Baseline (Month 0) Through Month 24 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.
Change in Morning Stiffness in Participants, Grouped by Therapy Strategy Baseline (Month 0) Through Month 24 A numeric rating scale (NRS) is used to assess severity and length of morning stiffness in the past 7 days.
Percentage of Participants in LDA that Achieve Glucocorticoid Dose <5 mg/Day Per Visit Through Month 24 LDA is defined as DAS28-CRP\<3.2.
Trial Locations
- Locations (263)
Hospital Italiano La Plata /ID# 222190
🇦🇷La Plata, Buenos Aires, Argentina
CER Instituto Medico /ID# 222193
🇦🇷Quilmes, Buenos Aires, Argentina
Organizacion Medica de Investigacion (OMI) /ID# 222187
🇦🇷Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina
CIER Centro de Investigaciones en Enfermedades Reumaticas /ID# 231769
🇦🇷Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina
Instituto CAICI S.R.L /ID# 222191
🇦🇷Rosario, Santa Fe, Argentina
CIMER Centro Integral de Medicina Respiratoria /ID# 222188
🇦🇷San Miguel de Tucuman, Tucuman, Argentina
DOM Centro de Reumatologia /ID# 222194
🇦🇷Buenos Aires, Argentina
Instituto Medico Strusberg /ID# 222189
🇦🇷Cordoba, Argentina
Instituto de Cardiologia /ID# 226634
🇦🇷Santiago Del Estero, Argentina
Genesis Research Services /ID# 224060
🇦🇺Broadmeadow, New South Wales, Australia
Scroll for more (253 remaining)Hospital Italiano La Plata /ID# 222190🇦🇷La Plata, Buenos Aires, Argentina