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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04497597
Ethics application status
Date submitted
30/07/2020
Date registered
4/08/2020
Date last updated
3/02/2021

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 - Remission is defined as Disease Activity Score at 28 joints (DAS28) C-reactive Protein (CRP)<2.6.
Timepoint [1] 0 0
At Month 6
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
At Month 12
Secondary outcome [1] 0 0
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.
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 - LDA is defined as DAS28-CRP=3.2. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.
Timepoint [2] 0 0
Through Month 24
Secondary outcome [3] 0 0
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.
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 - Remission is defined as DAS28-CRP<2.6. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.
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 - LDA is defined as DAS28-CRP=3.2. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.
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 - LDA is defined as DAS28-CRP<3.2.
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 - Remission is defined as DAS28-CRP<2.6.
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 - Percentage of participants who achieved a glucocorticoid dose <5 mg/day without 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) - 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 - Remission is defined as DAS28-CRP<2.6.
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 - LDA is defined as DAS28-CRP<3.2.
Timepoint [11] 0 0
Through Month 24
Secondary outcome [12] 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 Monotherapy - Remission is defined as DAS28-CRP<2.6.
Timepoint [12] 0 0
Through Month 24
Secondary outcome [13] 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 Monotherapy - LDA is defined as DAS28-CRP<3.2.
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 - Remission is defined as DAS28-CRP<2.6.
Timepoint [14] 0 0
Through Month 24
Secondary outcome [15] 0 0
Time to the Discontinuation of Upadacitinib - Time to the discontinuation of Upadacitinib.
Timepoint [15] 0 0
Through Month 24
Secondary outcome [16] 0 0
Time to First Treatment Adjustment - Treatment Adjustment is defined as treatment escalation/de-escalation/ addition/withdrawal.
Timepoint [16] 0 0
Baseline (Month 0) Through Month 24
Secondary outcome [17] 0 0
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.
Timepoint [17] 0 0
Through Month 24
Secondary outcome [18] 0 0
Percentage of Participants Achieving Remission Grouped by Therapy Strategy - Remission is defined as DAS28-CRP<2.6, SDAI=3.3 and CDAI =2.8.
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 - 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.
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 - 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.
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 - A VAS is used to assess worst joint pain in the past 7 days.
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 - A numeric rating scale (NRS) is used to assess severity and length of morning stiffness in the past 7 days.
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 - 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).
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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Genesis Research Services Pty Ltd /ID# 224060 - Broadmeadow
Recruitment hospital [2] 0 0
BJC Health /ID# 223884 - Paramatta
Recruitment hospital [3] 0 0
Emeritus Research /ID# 223883 - Camberwell
Recruitment hospital [4] 0 0
Wexford Medical Centre /ID# 223886 - Murdoch
Recruitment hospital [5] 0 0
Scott Walter Graf /ID# 223958 - Adelaide
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
2150 - Paramatta
Recruitment postcode(s) [3] 0 0
3124 - Camberwell
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Santa Fe
Country [3] 0 0
Argentina
State/province [3] 0 0
Ciudad Autonoma Buenos Aires
Country [4] 0 0
Argentina
State/province [4] 0 0
Cordoba
Country [5] 0 0
Argentina
State/province [5] 0 0
Quilmes
Country [6] 0 0
Argentina
State/province [6] 0 0
San Miguel de Tucuman
Country [7] 0 0
Austria
State/province [7] 0 0
Wien
Country [8] 0 0
Austria
State/province [8] 0 0
Hollabrunn
Country [9] 0 0
Austria
State/province [9] 0 0
Vienna
Country [10] 0 0
Belgium
State/province [10] 0 0
Antwerpen
Country [11] 0 0
Belgium
State/province [11] 0 0
Hainaut
Country [12] 0 0
Belgium
State/province [12] 0 0
Oost-Vlaanderen
Country [13] 0 0
Belgium
State/province [13] 0 0
Aalst
Country [14] 0 0
Belgium
State/province [14] 0 0
Brugge
Country [15] 0 0
Belgium
State/province [15] 0 0
Brussels
Country [16] 0 0
Belgium
State/province [16] 0 0
Charleroi
Country [17] 0 0
Belgium
State/province [17] 0 0
Genk
Country [18] 0 0
Belgium
State/province [18] 0 0
Gistel
Country [19] 0 0
Belgium
State/province [19] 0 0
Hasselt
Country [20] 0 0
Belgium
State/province [20] 0 0
Liege
Country [21] 0 0
Belgium
State/province [21] 0 0
Sijsele
Country [22] 0 0
Belgium
State/province [22] 0 0
Sint-Niklaas
Country [23] 0 0
Belgium
State/province [23] 0 0
Yvoir
Country [24] 0 0
France
State/province [24] 0 0
Centre-Val De Loire
Country [25] 0 0
France
State/province [25] 0 0
Cote-d Or
Country [26] 0 0
France
State/province [26] 0 0
Deux-Sevres
Country [27] 0 0
France
State/province [27] 0 0
Doubs
Country [28] 0 0
France
State/province [28] 0 0
Franche-Comte
Country [29] 0 0
France
State/province [29] 0 0
Haute-Garonne
Country [30] 0 0
France
State/province [30] 0 0
Herault
Country [31] 0 0
France
State/province [31] 0 0
Loire
Country [32] 0 0
France
State/province [32] 0 0
Provence-Alpes-Cote-d Azur
Country [33] 0 0
France
State/province [33] 0 0
Albi
Country [34] 0 0
France
State/province [34] 0 0
Amiens
Country [35] 0 0
France
State/province [35] 0 0
Angouleme CEDEX 9
Country [36] 0 0
France
State/province [36] 0 0
Arras CEDEX
Country [37] 0 0
France
State/province [37] 0 0
Bordeaux
Country [38] 0 0
France
State/province [38] 0 0
Boulogne sur Mer
Country [39] 0 0
France
State/province [39] 0 0
Brest
Country [40] 0 0
France
State/province [40] 0 0
Cahors
Country [41] 0 0
France
State/province [41] 0 0
Caluire Et Cuire
Country [42] 0 0
France
State/province [42] 0 0
Chambray Les Tours
Country [43] 0 0
France
State/province [43] 0 0
Cholet
Country [44] 0 0
France
State/province [44] 0 0
Clermont Ferrand
Country [45] 0 0
France
State/province [45] 0 0
Corbeil Essonnes
Country [46] 0 0
France
State/province [46] 0 0
Grenoble
Country [47] 0 0
France
State/province [47] 0 0
Haguenau
Country [48] 0 0
France
State/province [48] 0 0
Laon CEDEX
Country [49] 0 0
France
State/province [49] 0 0
Le Puy en Velay
Country [50] 0 0
France
State/province [50] 0 0
Lille
Country [51] 0 0
France
State/province [51] 0 0
Lyon
Country [52] 0 0
France
State/province [52] 0 0
Marseille
Country [53] 0 0
France
State/province [53] 0 0
Monaco
Country [54] 0 0
France
State/province [54] 0 0
Montauban
Country [55] 0 0
France
State/province [55] 0 0
Montpellier
Country [56] 0 0
France
State/province [56] 0 0
Morlaix
Country [57] 0 0
France
State/province [57] 0 0
Moulins
Country [58] 0 0
France
State/province [58] 0 0
Mulhouse
Country [59] 0 0
France
State/province [59] 0 0
Nantes
Country [60] 0 0
France
State/province [60] 0 0
Paris
Country [61] 0 0
France
State/province [61] 0 0
Pierre Benite
Country [62] 0 0
France
State/province [62] 0 0
Reims
Country [63] 0 0
France
State/province [63] 0 0
Rennes CEDEX 2
Country [64] 0 0
France
State/province [64] 0 0
Roanne
Country [65] 0 0
France
State/province [65] 0 0
Roubaix, Cedex 01
Country [66] 0 0
France
State/province [66] 0 0
Rouen
Country [67] 0 0
France
State/province [67] 0 0
Saint Mande
Country [68] 0 0
France
State/province [68] 0 0
Ste Maxime
Country [69] 0 0
France
State/province [69] 0 0
Strasbourg Cedex
Country [70] 0 0
France
State/province [70] 0 0
Strasbourg
Country [71] 0 0
France
State/province [71] 0 0
Tarbes CEDEX 9
Country [72] 0 0
France
State/province [72] 0 0
Thionville
Country [73] 0 0
France
State/province [73] 0 0
Villeneuve Sur Lot CEDEX
Country [74] 0 0
Germany
State/province [74] 0 0
Baden-Wuerttemberg
Country [75] 0 0
Germany
State/province [75] 0 0
Berlin
Country [76] 0 0
Germany
State/province [76] 0 0
Braunschweig
Country [77] 0 0
Germany
State/province [77] 0 0
Cologne
Country [78] 0 0
Germany
State/province [78] 0 0
Erfurt
Country [79] 0 0
Germany
State/province [79] 0 0
Hamburg
Country [80] 0 0
Germany
State/province [80] 0 0
Heidelberg
Country [81] 0 0
Israel
State/province [81] 0 0
Tel-Aviv
Country [82] 0 0
Israel
State/province [82] 0 0
Afula
Country [83] 0 0
Israel
State/province [83] 0 0
Hadera
Country [84] 0 0
Israel
State/province [84] 0 0
Haifa
Country [85] 0 0
Israel
State/province [85] 0 0
Kfar Saba
Country [86] 0 0
Israel
State/province [86] 0 0
Nahariya
Country [87] 0 0
Israel
State/province [87] 0 0
Ramat Gan
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Leningradskaya Oblast
Country [89] 0 0
Russian Federation
State/province [89] 0 0
Khanty-mansiysk
Country [90] 0 0
Russian Federation
State/province [90] 0 0
Petrozavodsk
Country [91] 0 0
Russian Federation
State/province [91] 0 0
Tomsk
Country [92] 0 0
Russian Federation
State/province [92] 0 0
Yaroslavl
Country [93] 0 0
Switzerland
State/province [93] 0 0
Sankt Gallen
Country [94] 0 0
Switzerland
State/province [94] 0 0
Aarau
Country [95] 0 0
Switzerland
State/province [95] 0 0
Basel
Country [96] 0 0
Switzerland
State/province [96] 0 0
Bern
Country [97] 0 0
Switzerland
State/province [97] 0 0
Fribourg
Country [98] 0 0
Switzerland
State/province [98] 0 0
Lausanne
Country [99] 0 0
Switzerland
State/province [99] 0 0
Weinfelden
Country [100] 0 0
Uruguay
State/province [100] 0 0
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/show/NCT04497597
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries

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