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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04497597




Registration number
NCT04497597
Ethics application status
Date submitted
30/07/2020
Date registered
4/08/2020
Date last updated
7/06/2024

Titles & IDs
Public title
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
Scientific title
Upadacitinib Treatment Patterns, Achievement of Treatment Targets and Maintenance of Response in Moderate to Severe Rheumatoid Arthritis Patients in Real-World Practice (UPHOLD)
Secondary ID [1] 0 0
P20-095
Universal Trial Number (UTN)
Trial acronym
UPHOLD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis (RA) 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants receiving Upadacitinib - Participants receiving Upadacitinib for moderate to severe rheumatoid arthritis (RA).
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieve Remission
Timepoint [1] 0 0
At Month 6
Primary outcome [2] 0 0
Percentage of Participants Who Achieve Remission at 6 Months and Maintain Remission
Timepoint [2] 0 0
At Month 12
Secondary outcome [1] 0 0
Percentage of Participants Who Achieve Remission at 6 Months and Maintain Remission
Timepoint [1] 0 0
At Month 24
Secondary outcome [2] 0 0
Percentage of Participants Who Achieve Low Disease Activity (LDA) at 6 months that maintain LDA
Timepoint [2] 0 0
Through Month 24
Secondary outcome [3] 0 0
Percentage of Participants Who Achieve Remission at 3 Months and Maintain Remission
Timepoint [3] 0 0
Through Month 24
Secondary outcome [4] 0 0
Percentage of Participants Who Achieve Remission at 6 Months and Maintain Remission Grouped by Glucocorticoid Dose
Timepoint [4] 0 0
At Month 12
Secondary outcome [5] 0 0
Percentage of Participants Who Achieve LDA at 3 months that maintain LDA Grouped by Glucocorticoid Dose
Timepoint [5] 0 0
Through Month 6
Secondary outcome [6] 0 0
Percentage of Participants in LDA that Achieve Glucocorticoid Dose <5 mg/Day Per Visit
Timepoint [6] 0 0
Through Month 24
Secondary outcome [7] 0 0
Percentage of Participants in Remission that Achieve Glucocorticoid Dose <5 mg/Day Per Visit
Timepoint [7] 0 0
Through Month 24
Secondary outcome [8] 0 0
Percentage of Participants Who Achieved a Glucocorticoid Dose <5 mg/Day Without Conventional Synthetic Disease Modifying Anti Rheumatic Drug (csDMARD) Intensification
Timepoint [8] 0 0
At Month 6
Secondary outcome [9] 0 0
Percentage of Participants Who Initiated Upadacitinib as Combination Therapy (csDMARD +/- Glucocorticoids) That Moved to Monotherapy (+/- Glucocorticoids)
Timepoint [9] 0 0
Through Week 24
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
Through Month 24
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
Through Month 24
Secondary outcome [12] 0 0
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
Timepoint [12] 0 0
Through Month 24
Secondary outcome [13] 0 0
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
Timepoint [13] 0 0
Through Month 24
Secondary outcome [14] 0 0
Percentage of Participants Who Do Not Achieve Remission at Any Point in the Study
Timepoint [14] 0 0
Through Month 24
Secondary outcome [15] 0 0
Time to the Discontinuation of Upadacitinib
Timepoint [15] 0 0
Through Month 24
Secondary outcome [16] 0 0
Time to First Treatment Adjustment
Timepoint [16] 0 0
Baseline (Month 0) Through Month 24
Secondary outcome [17] 0 0
Percentage of Participants Achieving LDA Grouped by Therapy Strategy
Timepoint [17] 0 0
Through Month 24
Secondary outcome [18] 0 0
Percentage of Participants Achieving Remission Grouped by Therapy Strategy
Timepoint [18] 0 0
Through Month 24
Secondary outcome [19] 0 0
Change in Medication Burden Treatment Burden Questionnaire (TBQ) in Participants, Grouped by Therapy Strategy
Timepoint [19] 0 0
Through Week 24
Secondary outcome [20] 0 0
Change in Physical Function Health Assessment Questionnaire - Disability Index (HAQ-DI) in Participants, Grouped by Therapy Strategy
Timepoint [20] 0 0
Baseline (Month 0) Through Month 24
Secondary outcome [21] 0 0
Change in Pain Visual Analogue Scale (VAS) in participants, Grouped by Therapy Strategy
Timepoint [21] 0 0
Baseline (Month 0) Through Month 24
Secondary outcome [22] 0 0
Change in Morning Stiffness in Participants, Grouped by Therapy Strategy
Timepoint [22] 0 0
Baseline (Month 0) Through Month 24
Secondary outcome [23] 0 0
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) in Participants, Grouped by Therapy Strategy
Timepoint [23] 0 0
Baseline (Month 0) Through Month 24

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior treatment with Upadacitinib.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/05/2024
Sample size
Target
Accrual to date
Final
1532
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Genesis Research Services /ID# 224060 - Broadmeadow
Recruitment hospital [2] 0 0
BJC Health /ID# 223884 - Paramatta
Recruitment hospital [3] 0 0
Private Practice - Scott Walter Graf /ID# 223958 - Adelaide
Recruitment hospital [4] 0 0
Emeritus Research /ID# 223883 - Camberwell
Recruitment hospital [5] 0 0
Joint West Rheumatology /ID# 223886 - Murdoch
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
2150 - Paramatta
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3124 - Camberwell
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment outside Australia
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autonoma De Buenos Aires
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Taoyuan City
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Dubai
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Montevideo

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04497597
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
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AbbVie
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Contact person for public queries
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Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04497597