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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 (UPHOLD)

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ClinicalTrials.gov Identifier: NCT04497597
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : October 13, 2021
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Rheumatoid Arthritis (RA)

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Study Type : Observational
Estimated Enrollment : 1660 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Upadacitinib Treatment Patterns, Achievement of Treatment Targets and Maintenance of Response in Moderate to Severe Rheumatoid Arthritis Patients in Real-World Practice (UPHOLD)
Actual Study Start Date : October 16, 2020
Estimated Primary Completion Date : February 15, 2024
Estimated Study Completion Date : February 15, 2024

Resource links provided by the National Library of Medicine


Group/Cohort
Participants receiving Upadacitinib
Participants receiving Upadacitinib for moderate to severe rheumatoid arthritis (RA).



Primary Outcome Measures :
  1. Percentage of Participants Who Achieve Remission [ Time Frame: At Month 6 ]
    Remission is defined as Disease Activity Score at 28 joints (DAS28) C-reactive Protein (CRP)<2.6.

  2. Percentage of Participants Who Achieve Remission at 6 Months and Maintain Remission [ Time Frame: 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.


Secondary Outcome Measures :
  1. Percentage of Participants Who Achieve Remission at 6 Months and Maintain Remission [ Time Frame: 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.

  2. Percentage of Participants Who Achieve Low Disease Activity (LDA) at 6 months that maintain LDA [ Time Frame: 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.

  3. Percentage of Participants Who Achieve Remission at 3 Months and Maintain Remission [ Time Frame: 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.

  4. Percentage of Participants Who Achieve Remission at 6 Months and Maintain Remission Grouped by Glucocorticoid Dose [ Time Frame: 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.

  5. Percentage of Participants Who Achieve LDA at 3 months that maintain LDA Grouped by Glucocorticoid Dose [ Time Frame: 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.

  6. Percentage of Participants in LDA that Achieve Glucocorticoid Dose <5 mg/Day Per Visit [ Time Frame: Through Month 24 ]
    LDA is defined as DAS28-CRP<3.2.

  7. Percentage of Participants in Remission that Achieve Glucocorticoid Dose <5 mg/Day Per Visit [ Time Frame: Through Month 24 ]
    Remission is defined as DAS28-CRP<2.6.

  8. Percentage of Participants Who Achieved a Glucocorticoid Dose <5 mg/Day Without Conventional Synthetic Disease Modifying Anti Rheumatic Drug (csDMARD) Intensification [ Time Frame: At Month 6 ]
    Percentage of participants who achieved a glucocorticoid dose <5 mg/day without csDMARD intensification.

  9. Percentage of Participants Who Initiated Upadacitinib as Combination Therapy (csDMARD +/- Glucocorticoids) That Moved to Monotherapy (+/- Glucocorticoids) [ Time Frame: Through Week 24 ]
    Percentage of participants who initiated Upadacitinib as combination therapy (csDMARD +/- Glucocorticoids) that moved to monotherapy (+/- glucocorticoids).

  10. 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 [ Time Frame: Through Month 24 ]
    Remission is defined as DAS28-CRP<2.6.

  11. 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 [ Time Frame: Through Month 24 ]
    LDA is defined as DAS28-CRP<3.2.

  12. 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 [ Time Frame: Through Month 24 ]
    Remission is defined as DAS28-CRP<2.6.

  13. 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 [ Time Frame: Through Month 24 ]
    LDA is defined as DAS28-CRP<3.2.

  14. Percentage of Participants Who Do Not Achieve Remission at Any Point in the Study [ Time Frame: Through Month 24 ]
    Remission is defined as DAS28-CRP<2.6.

  15. Time to the Discontinuation of Upadacitinib [ Time Frame: Through Month 24 ]
    Time to the discontinuation of Upadacitinib.

  16. Time to First Treatment Adjustment [ Time Frame: Baseline (Month 0) Through Month 24 ]
    Treatment Adjustment is defined as treatment escalation/de-escalation/ addition/withdrawal.

  17. Percentage of Participants Achieving LDA Grouped by Therapy Strategy [ Time Frame: Through Month 24 ]
    LDA is defined as DAS28-CRP<3.2, Simplified Disease Activity Index (SDAI) ≤11 and Clinical Disease Activity Index (CDAI) ≤10.

  18. Percentage of Participants Achieving Remission Grouped by Therapy Strategy [ Time Frame: Through Month 24 ]
    Remission is defined as DAS28-CRP<2.6, SDAI≤3.3 and CDAI ≤2.8.

  19. Change in Medication Burden Treatment Burden Questionnaire (TBQ) in Participants, Grouped by Therapy Strategy [ Time Frame: 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.

  20. Change in Physical Function Health Assessment Questionnaire - Disability Index (HAQ-DI) in Participants, Grouped by Therapy Strategy [ Time Frame: 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.

  21. Change in Pain Visual Analogue Scale (VAS) in participants, Grouped by Therapy Strategy [ Time Frame: Baseline (Month 0) Through Month 24 ]
    A VAS is used to assess worst joint pain in the past 7 days.

  22. Change in Morning Stiffness in Participants, Grouped by Therapy Strategy [ Time Frame: 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.

  23. Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) in Participants, Grouped by Therapy Strategy [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults receiving Upadacitinib according to the product prescribing information, for moderate to severe active Rheumatoid Arthritis (RA).
Criteria

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.

Exclusion Criteria:

  • Prior treatment with Upadacitinib.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04497597


Contacts
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Contact: Tanja Plath 844-663-3742 tanja.plath@abbvie.com

Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04497597    
Other Study ID Numbers: P20-095
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: October 13, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Rheumatoid Arthritis
Upadacitinib
RINVOQ
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases