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NCT Number: NCT04826536

A Study of Treatment Patterns and Clinical Outcomes of Psoriasis in Japan

The purpose of this study is to understand current real-world treatment patterns and clinical outcomes, reasons for switching treatment, and participant characteristics using each systemic psoriasis treatment in Japan.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Minato-ku, Tokyo, 1070052, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of psoriasis
  • Can be followed for at least 2 years
  • Treated with any of the following systemic therapy for psoriasis at time of follow-up start: Tumor Necrosis Factor (TNF) inhibitors (infliximab, adalimumab, and certolizumab pegol), Interleukin (IL)-12/23 inhibitors (ustekinumab), IL-23 inhibitors(guselkumab, risankizumab, and tildrakizumab), IL-17 inhibitors (secukinumab, ixekizumab, and brodalumab), Apremilast, Methotrexate, Cyclosporine, Etretinate

Exclusion criteria

  • Enrolled in any clinical trials for psoriasis in their follow-up period
  • Developed psoriatic arthritis, guttate psoriasis, erythrodermic psoriasis, and pustular psoriasis at time of start date
  • Treated with any of the following systemic therapy before they were diagnosed with psoriasis: TNF inhibitors (infliximab, adalimumab, and certolizumab pegol), IL-12/23 inhibitors (ustekinumab), IL-23 inhibitors(guselkumab, risankizumab, and tildrakizumab), IL-17 inhibitors (secukinumab, ixekizumab, and brodalumab), Apremilast, Methotrexate, Cyclosporine, Etretinate

Treatment and study plan

Primary outcomes

  1. Distribution of participant background at first visit: Age

    Time frame: At Baseline

  2. Distribution of participant background at first visit: Sex

    Time frame: At Baseline

  3. Distribution of participant background at first visit: Duration with psoriasis

    Time frame: At Baseline

  4. Distribution of participant background at first visit: Comorbidities

    Time frame: At Baseline

  5. Distribution of participant background at first visit: Current status of phototherapy

    Time frame: At Baseline

  6. Treatment patterns: Drug names treated during study period

    Time frame: Up to 4 years

  7. Treatment patterns: Drug categories treated during study period

    Time frame: Up to 4 years

  8. Treatment patterns: Number of treatment changes during study period

    Time frame: Up to 4 years

  9. Treatment patterns: Treatment duration of each drug during study period

    Time frame: Up to 4 years

  10. Treatment patterns: Duration between withdrawal of one drug and start of a new drug during study period

    Time frame: Up to 4 years

  11. Treatment patterns: Adverse event (AE) at time of withdrawal of some drug

    Time frame: Up to 4 years

  12. Treatment patterns: Psoriasis area severity index (PASI) at time of withdrawal

    Time frame: Up to 4 years

  13. Treatment patterns: PASI at time of start of a new drug

    Time frame: Up to 4 years

  14. Treatment patterns: PASI improvement from start of one drug to withdrawal of other drug

    Time frame: Up to 4 years

  15. Treatment patterns: Reason for treatment change during study period

    Time frame: Up to 4 years

  16. Treatment patterns: Status of phototherapy combination with systemic treatment

    Time frame: Up to 4 years

Secondary outcomes

  1. Distribution of comorbidities that affect treatment choice and change

    Time frame: Up to 4 years

  2. Distribution of AEs that affect treatment choice and change

    Time frame: Up to 4 years

  3. Mean number of drug changes until participants achieve PASI 75 during study period

    Time frame: Up to 4 years

    75% reduction in the Psoriasis Area and Severity Index score (PASI 75)

  4. Mean number of drug changes until participants achieve PASI 90 during study period

    Time frame: Up to 4 years

    90% reduction in the Psoriasis Area and Severity Index score (PASI 90)

  5. Mean number of drug changes until participants achieve PASI 100 during study period

    Time frame: Up to 4 years

    100% reduction in the Psoriasis Area and Severity Index score (PASI 100)

  6. Total period until participants achieve PASI 75 during study period

    Time frame: Up to 4 years

  7. Total period until participants achieve PASI 90 during study period

    Time frame: Up to 4 years

  8. Total period until participants achieve PASI 100 during study period

    Time frame: Up to 4 years

  9. Mean period of participants achieve PASI 75 by each systemic treatment

    Time frame: Up to 4 years

  10. Mean period of participants achieve PASI 90 by each systemic treatment

    Time frame: Up to 4 years

  11. Mean period of participants achieve PASI 100 by each systemic treatment

    Time frame: Up to 4 years

  12. Description of relationship between the reasons for treatment change and period of withdrawal

    Time frame: Up to 4 years

  13. Efficacy after re-start treatment measured by PASI

    Time frame: Up to 4 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Treatment Patterns and Outcomes Study for Psoriasis (PSO) in Japan

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 1, 2021
Registry last updated
Jun 3, 2022

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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