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NCT Number: NCT07793773

Disease Impact and Its Correlation With Disease Activity in Psoriatic Arthritis

Psoriatic arthritis (PsA) is a chronic inflammatory musculoskeletal disorder that causes joint pain, stiffness, skin lesions, and functional disability, significantly affecting patients' quality of life. Patient-reported outcome measures (PROMs) provide essential insights into the impact of disease from the patient's perspective. The Psoriatic Arthritis Impact of Disease-12 (PsAID-12) questionnaire is a validated tool designed to evaluate 12 physical and psychological aspects of disease burden.

The main purpose of this cross-sectional study is to evaluate disease impact using the Arabic version of the PsAID-12 questionnaire and to investigate how disease impact correlates with clinical disease activity measured by the Disease Activity in Psoriatic Arthritis (DAPSA) score in adult patients with PsA.

Participants will undergo routine clinical and rheumatological evaluations, including joint examinations (tender and swollen joint counts), laboratory tests (complete blood count, inflammatory markers such as ESR and CRP, liver and kidney function tests, and lipid profile), and plain radiography of affected joints (hands, feet, and sacroiliac joints). Patients will also complete the Arabic PsAID-12 questionnaire and patient global and pain assessments. All assessments will take place during a single evaluation visit at Assiut University Hospital.

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Key information

Who can participate

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

Inclusion criteria

  • Patients diagnosed with psoriatic arthritis according to the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria
  • Age ≥ 18 years
  • Willingness to participate in the study and provide informed consent

Exclusion criteria

  • Patients younger than 18 years of age
  • Presence of other coexisting autoimmune diseases
  • Patients with advanced malignancy

Treatment and study plan

Primary outcomes

  1. Disease Impact Score Assessed by the Psoriatic Arthritis Impact of Disease (PsAID-12) Questionnaire

    Time frame: Baseline

    The Arabic version of the Psoriatic Arthritis Impact of Disease 12-item (PsAID-12) questionnaire is used to evaluate patient-reported disease impact. It assesses 12 domains: pain, fatigue, skin problems, work and leisure activities, functional capacity, discomfort, sleep disturbance, coping, anxiety/fear, embarrassment/shame, social participation, and depression. Each domain is scored on a numerical rating scale from 0 to 10, weighted, and aggregated into a total score ranging from 0 (no impact/best status) to 10 (extreme impact/worst status). Higher total scores indicate greater negative disease impact.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Assessment of Disease Impact in Patients With Psoriatic Arthritis and Its Correlation With Disease Activity

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

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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