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NCT Number: NCT04758117

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

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.

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Key information

Conditions

Psoriatic Arthritis Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Jonathan D. Chan Inc. /ID# 241611, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Real-World Effectiveness of Upadacitinib in Patients Joining Subgroups Either With Oligo- or Poly-ArtIcular Psoriatic Arthritis on Minimal Disease Activity

Acronym: UPJOINT

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 17, 2021
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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