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Completed

NCT Number: NCT05650060

Characteristics of Patients Treated With Secukinumab for Moderate to Severe Plaque Psoriasis

This study was a non-interventional, retrospective study collecting data from hospital medical records. Approximately 200 adult patients with moderate to severe plaque psoriasis who were treated with secukinumab from hospitals in Thailand that participated in this study were expected for data collection.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site

Bangkok, Thailand

About this study

The study was performed in 7 study sites in Thailand and planned to involve approximately 200 medical records.

At each study site, patients who were treated with secukinumab or had ever been treated with secukinumab for moderate to severe plaque psoriasis were included for screening by chronological order starting from the most recent date (April 2021) to September 2017. This was to include the most recent clinical practice in the study.

The data of patients diagnosed with moderate-to-severe chronic plaque-type psoriasis who received secukinumab in real clinical practice at least 1 dose were collected. The medical records were reviewed to collect the data from the date of the first diagnosis of psoriasis till the most recent dose of secukinumab.

The data of secukinumab use and clinical outcome (PASI score) were collected at 4 and 16 weeks after first dose initiation and at the most recent dose of secukinumab. The total number of secukinumab injections at the 3-time points were collected.

An index date was defined for each patient. The first secukinumab injection observed in the medical records was considered the index date for the exploratory endpoint.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult male or female aged ≥ 18 years at index date
  • Previous diagnosis of moderate to severe plaque psoriasis as hospital record with available baseline PASI at index date (date 0 to date -7 prior index date)
  • Initiated treatment with secukinumab for moderate to severe plaque psoriasis during September 2017-April 2021

Exclusion criteria

  • Patients diagnosed with other forms of psoriasis other than plaque-type

Treatment and study plan

secukinumab

Drug

all patients with psoriasis who received secukinumab

Primary outcomes

  1. Age

    Time frame: Baseline

    Age information was reported.

  2. Gender

    Time frame: Baseline

    Gender information was reported.

  3. Number of patients with Reimbursement scheme

    Time frame: Baseline

    Reimbursement scheme information was reported.

  4. Weight

    Time frame: During 3 months pre-baseline

    Weight information was reported.

  5. Height

    Time frame: During 3 months pre-baseline

    Height information was reported.

  6. BMI

    Time frame: During 3 months pre-baseline

    BMI information was reported.

  7. Co-morbidities

    Time frame: During 12 months pre-baseline

    • Crohn's Disease
    • Diabetes Mellitus
    • Dyslipidemia
    • Hypertension
    • Inflammatory Bowel Disease
    • Latent Tuberculosis
    • Psoriatic Arthritis (PsA)
  8. Psoriasis Area and Sensitivity Index (PASI) score

    Time frame: During 4 weeks pre-baseline

    Psoriasis Area and Severity Index (PASI) is the most widely used tool for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease).

  9. Percentage of Body Surface Area (BSA) involvement

    Time frame: During 4 weeks pre-baseline

    Percentage of Body Surface Area (BSA) involvement was reported.

  10. Disease Life Quality Index (DLQI) score

    Time frame: During 4 weeks pre-baseline

    The Dermatology Life Quality Index (DLQI) is a simple, self-administered and user-friendly validated questionnaire. The DLQI is designed to measure the health-related quality of life of adult patients suffering from a skin disease. The DLQI is a validated, 10-question, self-reported questionnaire to evaluate the patient's perception of the impact of psoriasis on quality of life. The DLQI was rated on a 4-point scale (0 = not at all to 3 = very much). The highest possible total score for the DLQI is 30 and higher scores indicate more severe impact on quality of life.

  11. Date of first symptom of psoriasis (PSO) / year

    Time frame: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)

    To describe the PSO treatment history

  12. Date of psoriasis diagnosis / year

    Time frame: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)

    To describe the PSO treatment history

  13. Duration of psoriasis diagnosis

    Time frame: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)

    To describe the PSO treatment history

  14. Date of first systemic treatment/ year

    Time frame: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)

    To describe the PSO treatment history

  15. Date of first biologic agent/year

    Time frame: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)

    To describe the PSO treatment history

  16. Duration of topical therapy

    Time frame: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)

    To describe the PSO treatment history

  17. History of topical therapy

    Time frame: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)

    To describe the PSO treatment history

  18. Duration of systemic therapy

    Time frame: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)

    To describe the PSO treatment history

  19. History of systemic therapy

    Time frame: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)

    To describe the PSO treatment history

  20. Duration of biologic therapy

    Time frame: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)

    To describe the PSO treatment history

  21. History of biologic therapy

    Time frame: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)

    To describe the PSO treatment history

  22. Date of PsA diagnosis/year

    Time frame: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)

    To describe the PSO treatment history

  23. Duration of PsA diagnosis

    Time frame: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)

    To describe the PSO treatment history

  24. Number of patients with baseline PSO treatment

    Time frame: During 12 months pre-baseline

    Topical Therapies

    • Topical corticosteroid
    • Coal tar
    • Salicylic acid
    • Vitamin D analogues
    • Anthralin
    • Calcineurin inhibitors
    • Others Oral systemic therapies
    • Methotrexate
    • Acitretin
    • Retinoid
    • Cyclosporine
    • Azathioprine
    • Hydroxyurea
    • Leflunomide
    • Sulfasalazine
    • Others Biologic therapy
    • Infliximab
    • Etanercept
    • Ustekinumab
    • Brodalumab
    • Guselkumab
    • Ixekizumab
    • Others
  25. Duration since the discontinuation of the latest biological agents

    Time frame: Baseline

    Secukinumab therapy

  26. Medication use concomitant to index secukinumab prescription

    Time frame: Baseline

    Secukinumab therapy

  27. Treatment pattern with secukinumab

    Time frame: Baseline

    Secukinumab therapy

  28. Treatment duration since the first dosing till the most recent dosing

    Time frame: Baseline

    Secukinumab therapy

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

The Characteristics of Patients Treated With Secukinumab for Moderate to Severe Plaque Psoriasis in Real-world Practice in Thailand

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 14, 2022
Registry last updated
Apr 6, 2023

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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