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Completed

NCT Number: NCT07498543

Impact of Clinical and Psychological Factors on Satisfaction With Treatment in Psoriatic Patients on Biological Therapy

Psoriasis is a chronic-recurrent inflammatory disease with a significant impact on patients' physical and psychological well-being. Fortunately, in recent years, the introduction of increasingly selective biologic therapies on the market has resulted in an excellent control of the disease, with high rates of complete (PASI100) or nearly complete (PASI90) in treated patients. At the same time, however, various studies have shown that these patients' quality of life and satisfaction with these therapies do not always correlate with the high levels of efficacy of these drugs, and this is often a limitation, as it has negative feedbacks on treatment adherence. This study aims to identify, through the use of questionnaires, demographic, clinical and psychological factors that might best correlate with the satisfaction of psoriatic patients on therapy systemic with biologic drugs for more than one year afferent to the Dermatology Outpatient Clinics of the Policlinico Universitario A. Gemelli-IRCCS.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli

Rome, Lazio, 00168, Italy

Who can participate

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

Inclusion criteria

  • Patients with age of more than18 years, of either sex;
  • Diagnosis of Plaque Psoriasis, with or without concomitant arthritis;
  • Patients who have been treated with systemic biologic drugs for at least one year whose available data on disease severity (PASI) and quality of life (DLQI) at baseline (before initiation treatment);
  • Signature of written informed consent;

Exclusion criteria

  • Presence of an already diagnosed psychiatric condition.
  • Patients with variants of psoriasis (pustular, guttate, palmoplantar)

Treatment and study plan

Questionnaire

Other

DLQI, PHQ 9, TSQM 2, DS14

Primary outcomes

  1. Primary Outcome assessed by Treatment Satisfaction Questionnaire for Medication (TSQM-9) - towards treatment, in a sample of psoriatic patients on therapy for more than one year with a biologic drug

    Time frame: 1 year

    The primary objective of the study is to evaluate satisfaction with treatment of psoriatic patients who have been on therapy for at least one year with a biologic drug. Satisfaction will be expressed in terms of a score derived from the Treatment Satisfaction Questionnaire for Medication (TSQM-9).(0-100) higher scores mean a better outcome.

  2. DLQI

    Time frame: 1 year

    Evaluate after 1 year of treatment with biologic drug:

    • the DLQI (0-30). Lower scores mean a better outcome.
    • the DLQI improvement from baseline

  3. Effect of clinical variables on satisfaction of treatment

    Time frame: 1 year

    Evaluate the effect of objectively measurable clinical variables such as:

    • the age of onset and duration of disease
    • the presence of comorbidities
    • the possible combination with other treatments
    • the residual location of disease
    • the presence/absence of psoriatic arthritis
    • the residual PASI
    • the PASI improvement from baseline
    • The achievement of an optimal response in terms of:
    • Absolute PASI
    • 90% and 100% reduction in PASI score from baseline
    • DLQI between 0-5

Secondary outcomes

  1. Correlation of Type D personality with satisfaction with treatment.

    Time frame: 1 year

    As a secondary objective, the relationship of specific characteristics will also be assessed.

    psychopathology (Type D personality, Depression) with satisfaction with treatment.

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Acronym: PsoSAT

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 27, 2026
Registry last updated
Mar 27, 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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