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A Study of Oral Upadacitinib Tablets to Assess the Change in Disease Symptoms in Adult Canadian Participants With Moderate to Severe Rheumatoid Arthritis (CLOSEUP)

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ClinicalTrials.gov Identifier: NCT04574492
Recruitment Status : Recruiting
First Posted : October 5, 2020
Last Update Posted : September 13, 2022
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. This study will assess how effective Upadacitinib is in changing the disease symptoms in Canadian participants with RA.

Upadacitinib is a drug approved for the treatment of moderately to severely active rheumatoid arthritis. Adult Canadian participants with moderate to severe RA who have been prescribed upadacitinib by their physicians will be enrolled. Approximately, 390 participants will be enrolled this study, in multiple sites within Canada.

Participants will receive Upadacitinib as prescribed by the physician and will be followed for approximately 24 months.

There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits 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 : 390 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Canadian Real-life Post-marketing Observational Study Assessing the Effectiveness of Upadacitinib for Treating Rheumatoid Arthritis (CLOSEUP)
Actual Study Start Date : October 7, 2020
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 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 Clinical Remission [ Time Frame: At Month 6 ]
    Clinical remission is defined as Disease Activity Score at 28 joints (DAS28) C-reactive Protein (CRP)<2.6.


Secondary Outcome Measures :
  1. Change in Pain Using Visual Analogue Scale (VAS) [ Time Frame: Baseline (Month 0) Through Month 24 ]
    Pain is defined using VAS, where a higher score indicates worse pain.

  2. Duration of Morning Stiffness [ Time Frame: Baseline (Month 0) Through Month 24 ]
    Duration of morning joint stiffness is defined using VAS, where a higher score indicates worse joint stiffness.

  3. Severity of Morning Stiffness [ Time Frame: Baseline (Month 0) Through Month 24 ]
    Severity of morning joint stiffness is defined using VAS, where a higher score indicates worse joint stiffness.

  4. Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) [ 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).

  5. Percentage of Participants Achieving Clinical Remission [ Time Frame: Baseline (Month 0) Through Month 24 ]
    Clinical Remission is defined as DAS28-CRP<2.6, Simplified Disease Activity Index (SDAI) ≤3.3, Clinical Disease Activity Index (CDAI) ≤2.8, American College of Rheumatology (ACR)-European League Against Rheumatism (EULAR) Boolean remission.

  6. Percentage of Participants Achieving Low Disease Activity (LDA) [ Time Frame: Baseline (Month 0) Through Month 24 ]
    LDA is defined as DAS28-CRP<3.2, SDAI ≤11, CDAI ≤10.

  7. Earliest Date When a Response to Treatment is Known to Have Occurred [ Time Frame: Baseline (Month 0) Through Month 24 ]
    Earliest date when a response to treatment is known to have occurred.

  8. Earliest Date When Their RA is Known to have Returned (In those Participants who Achieve a Response to Treatment) [ Time Frame: Through Month 24 ]
    Earliest date when their RA is known to have returned (In those participants who achieve a response to treatment).

  9. Change in DAS28-CRP Score [ Time Frame: Baseline (Month 0) Through Month 24 ]
    The DAS28-CRP used to evaluate disease activity in participants with RA, where worsening RA activity is defined by a higher score.

  10. Change in CDAI Score [ Time Frame: Baseline (Month 0) Through Month 24 ]
    The CDAI is used to evaluate disease activity in participants with RA , where worsening RA activity is defined by a higher score.

  11. Change in Tender Joint Count [ Time Frame: Baseline (Month 0) Through Month 24 ]
    Change in Tender Joint Count.

  12. Change in Swollen Joint Count [ Time Frame: Baseline (Month 0) Through Month 24 ]
    Change in Swollen Joint Count.

  13. Change in Physical Function (HAQ-DI) Score [ Time Frame: Baseline (Month 0) Through Month 24 ]
    The HAQ DI is a questionnaire that determines physical function.

  14. Change in Patient Assessment of Global Disease Activity (PtGA) [ Time Frame: Baseline (Month 0) Through Month 24 ]
    The PtGA is a outcome instrument to assess the participant's assessment of disease severity.

  15. Change in Physician Assessment of Global Disease Activity (PGA) [ Time Frame: Baseline (Month 0) Through Month 24 ]
    The PGA is a outcome instrument to assess the participant's assessment of disease severity.

  16. Percentage of Participants Who Discontinue Upadacitinib [ Time Frame: Through Month 24 ]
    Percentage of participants who discontinue Upadacitinib.

  17. Time of Discontinuation from Upadacitinib Initiation Date [ Time Frame: Through Month 24 ]
    Time of discontinuation from Upadacitinib initiation date.

  18. Reasons for Upadacitinib Treatment Discontinuation [ Time Frame: Through Month 24 ]
    Reasons for Upadacitinib treatment discontinuation.

  19. Immediate Change in RA Medications Following Discontinuation of Upadacitinib [ Time Frame: Through Month 24 ]
    Immediate change in RA medications following discontinuation of Upadacitinib.

  20. Percentage of Participants Who Achieve Sustained Remission Following Discontinuation of Upadacitinib [ Time Frame: Through Month 24 ]
    Clinical remission is defined as DAS28 and CRP<2.6.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Participants receiving Upadacitinib according to the product prescribing information, for moderate to severe active Rheumatoid Arthritis (RA).
Criteria

Inclusion Criteria:

  • Diagnosis of moderate to severe Rheumatoid Arthritis (RA) according to the investigator.
  • Decision to initiate UPA treatment by investigator according to the local product label independent of the participant's participation in the study.
  • Has been previously treated with Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) and corresponds to one of the following subgroups:

    • Has not been previously exposed to any Biologic Disease-Modifying Antirheumatic Drugs (bDMARD) or Targeted Synthetic Disease-Modifying Antirheumatic Drugs (tsDMARD).
    • Has not been previously exposed to tsDMARD and has been previously exposed to <= 2 bDMARDs.
    • Has been previously treated with one tsDMARD and <=1 bDMARD prior to treatment with that tsDMARD.

Exclusion Criteria:

  • Presence of any condition that, in the opinion of the treating physician, prohibits the participant from participating in the study or obscures the assessment of the treatment of RA.
  • Diagnosis of rheumatic disease other than RA.
  • Diagnosis of juvenile RA.
  • Currently participating in an investigational clinical trial.
  • Has prior exposure to a bDMARD after exposure to a tsDMARD.
  • Has prior exposure to tsDMARD in an investigational clinical trial.

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): NCT04574492


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
Show Show 39 study locations
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: NCT04574492    
Other Study ID Numbers: P20-096
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: September 13, 2022
Last Verified: September 2022
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