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A Study to Assess the Change in Disease State in Adult Participants Being Treated With Oral Upadacitinib Tablets in Participants With Oligo- or Poly-artIcular Psoriatic Arthritis (UPJOINT)

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ClinicalTrials.gov Identifier: NCT04758117
Recruitment Status : Recruiting
First Posted : February 17, 2021
Last Update Posted : August 8, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:

Psoriatic arthritis (PsA) is a type of arthritis (swelling and stiffness in the joints) that is frequently seen in trial participants who also have the skin condition psoriasis. It is caused by the body's immune system mistakenly attacking healthy joint tissue causing inflammation, joint damage, disability, and a reduced life expectancy. The main objective of this study is to characterize attainment of minimal disease activity (MDA) at week 24 under continuous treatment with upadacitinib in participants with oligo- or polyarticular PsA as part of real-world practice.

Upadacitinib is a drug approved for the treatment of Psoriatic arthritis (PsA) in Germany and Canada. Approximately 380 adult participants with PsA at multiple sites in Germany and Canada.

Participants will receive oral Upadacitinib tablets per current local label, according to local standard of care and international guidelines.

There may be a higher burden for participants in this study compared to standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and by questionnaire.


Condition or disease
Psoriatic Arthritis

Study Design
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Study Type : Observational
Estimated Enrollment : 380 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real-World Effectiveness of Upadacitinib in Patients Joining Subgroups Either With Oligo- or Poly-ArtIcular Psoriatic Arthritis on Minimal Disease Activity
Actual Study Start Date : February 9, 2021
Estimated Primary Completion Date : March 29, 2024
Estimated Study Completion Date : March 29, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Participants Receiving Upadacitinib
Participants receiving Upadacitinib for psoriatic arthritis (PsA).


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Receiving Upadacitinib who Attain Minimal Disease Activity (MDA) [ Time Frame: At Week 24 ]
    MDA will be determined based on participants fulfilling 5 of 7 outcome measures: tender joint count 68 (TJC68) <= 1, swollen joint count (SJC66) ≤ 1, body surface area (BSA) <= 3%; Patient's Assessment of Pain numeric rating scale (NRS) <= 1.5, Patient's Global Assessment of Disease Activity (PtGA) NRS <= 2.0, Health Assessment Questionnaire Disability Index (HAQ-DI) <= 0.5, tender entheseal points <= 1.


Secondary Outcome Measures :
  1. Percentage of Participants Maintaining MDA Under Upadacitinib Treatment, in Participants who had Achieved MDA at Week 24 [ Time Frame: At Week 48 ]
    MDA will be determined based on participants fulfilling 5 of 7 outcome measures: TJC68 <= 1, SJC66 ≤ 1, BSA <= 3%; Patient's Assessment of Pain NRS <= 1.5, PtGA NRS <= 2.0, HAQ-DI <= 0.5, tender entheseal points <= 1.

  2. Mean change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 (Pain in Neck, Back or Hip) [ Time Frame: Baseline to Week 48 ]
    The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem).

  3. Mean Change in Disease Activity in PSoriatic Arthritis score (DAPSA) [ Time Frame: Baseline to Week 48 ]
    The DAPSA is a numerical sum of the 66 swollen and 68 tender joint counts, the participant pain and global assessments (each on a 0-10 scale) and C-reactive protein (CRP) (in mg/dL), thus ranging from 0 to about 160.

  4. Mean Change in Percentage of Participants with Dactylitis [ Time Frame: Baseline to Week 48 ]
    Mean change in percentage of participants with dactylitis.

  5. Mean Change in Number of Fingernails Affected with Psoriasis [ Time Frame: Baseline to Week 48 ]
    Mean change in number of fingernails affected with psoriasis.

  6. Mean Change in 12-Item Short Form Health Survey (SF-12) [ Time Frame: Baseline to Week 48 ]
    The SF-12 is a 12-item, patient-reported, generic, non-disease specific, overall HRQoL instrument with extensive use in multiple disease states.

  7. Mean Change in Dermatology Life Quality Index (DLQI) [in Participants with Skin Involvement] [ Time Frame: Baseline to Week 48 ]
    The DLQI consists of 10 questions concerning participants' perception of the impact of the skin disease on different aspects of their HRQoL over the previous week.


Eligibility Criteria
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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 with psoriatic arthritis (PsA).
Criteria

Inclusion Criteria:

  • Diagnosis of active Psoriatic Arthritis (PsA) upon judgment of the treating physician.
  • Swollen joint count (SJC) >= 1 out of 66 joints.
  • Decision on the treatment with Upadacitinib was made prior to any decision to approach the participant to participate in this study.

Exclusion Criteria:

  • Cannot be treated with Upadacitinib according to the local Upadacitinib Summary of Product Characteristics (SmPC).
  • Prior treatment with Upadacitinib.
  • Currently participating in interventional research or within the last 30 days.
Contacts and Locations
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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): NCT04758117


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

Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Additional Information:

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04758117    
Other Study ID Numbers: P20-483
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: August 8, 2022
Last Verified: August 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:
Psoriatic Arthritis
Oligoarticular Psoriatic Arthritis
Polyarticular Psoriatic Arthritis
Upadacitinib
Rinvoq
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
 Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases