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Completed

NCT Number: NCT04894890

A Prospective Multicenter Study for the Assessment of Treatment Patterns, Effectiveness and Safety of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis in a Real-world Setting in China

This non-interventional, prospective, multi-center study aims to provide short- and long- term treatment patterns, effectiveness, and safety of secukinumab in Chinese patients with moderate to severe plaque psoriasis (with and without PsA) initiating treatment of secukinumab.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Xicheng Direct, Beijing Municipality, China

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About this study

All patients will be followed up for 52 weeks no matter they adhere to secukinumab or they have shifted to other treatment plans. Data will be collected in conjunction with routine care visits, most likely happen at week 0, 4, 12, 16, 24, 36, 52. No extra study visits, examinations, laboratory tests or procedures will be mandated. If visits happen at other time points (not within the window period), then they will be counted as unscheduled visits.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged ≥ 18 years;
  • Diagnosis of clinically moderate to severe plaque-psoriasis;
  • Initiating treatment with secukinumab during the identification period or within 30 days prior to the index date;
  • Patient agrees to sign the informed consent

Exclusion criteria

  • Participation in any dermatology or rheumatology clinical trial, concurrent or within the last 30 days of the secukinumab initiating date

Treatment and study plan

secukinumab

Drug

There is no treatment allocation. Patients administered secukinumab by prescription that have started before inclusion of the patient into the study will be enrolled.

Other names: Cosentyx

Primary outcomes

  1. Percentage of patients achieving a 90% reduction in the Psoriasis Area and Severity Index (PASI) score

    Time frame: week 24

    The PASI is used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0.

Secondary outcomes

  1. Percentage of patients experiencing a 75% reduction of PASI (PASI75)

    Time frame: week 4, week12, week 16, week 24, week 36, week 52

    The PASI is used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0.

  2. Percentage of patients experiencing a 90% reduction of PASI (PASI90)

    Time frame: week 4, week12, week 16, week 36, week 52

    The PASI is used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0.

  3. Percentage of patients experiencing a 100% reduction of PASI (PASI100)

    Time frame: week 4, week12, week 16, week 24, week 36, week 52

    The PASI is used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0.

  4. Percentage of patients with absolute PASI change ≤1, ≤2, ≤3,and ≤5

    Time frame: week 4, week12, week 16, week 24, week 36, week 52

    The PASI is used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0

  5. Percentage of patients with Investigator Global Assessment Mod 2011 (IGA mod 2011) 0 or 1

    Time frame: week 4, week12, week 16, week 24, week 36, week 52

    The IGA mod 2011 rating scale for overall psoriatic disease can range from 0 to 4 (0: Clear, 1: almost clear, 2: mild, 3: moderate, 4: severe)

  6. Mean change of Investigator Global Assessment Mod 2011(IGA mod 2011)

    Time frame: week 4, week12, week 16, week 24, week 36, week 52

    The IGA mod 2011 rating scale for overall psoriatic disease can range from 0 to 4 (0: Clear, 1: almost clear, 2: mild, 3: moderate, 4: severe)

  7. Percentage of patients achieved (Body Surface Area) BSA≤1%

    Time frame: week 4, week12, week 16, week 24, week 36, week 52

    The total BSA affected by plaque-type psoriasis will be estimated from the percentages of areas affected, including head, trunk, upper limbs and lower limbs.

    The following calculations will be done: each reported percentage will be multiplied by its respective body region corresponding factor (head = 0.1, trunk = 0.3, upper limbs = 0.2, lower limbs = 0.4). The resulting four percentages will be added up to estimate the total BSA affected by psoriasis.

  8. Mean change in Dermatology life quality index (DLQI)

    Time frame: Baseline,week 4, week12, week 16, week 24, week 36, week 52

    DLQI is a 10-item general dermatology disability index designed to assess HRQoL in adult patients with skin diseases such as eczema, psoriasis, acne and viral warts. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment and work/school.

    Each item has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions.

    Scores range from 0 to 30 and higher scores indicate greater HRQoL impairment. Additionally, each subscale of the DLQI may be analyzed separately.

  9. Percentage of patients achieving DLQI 0 or 1 response

    Time frame: week 4, week12, week 16, week 24, week 36, week 52

    DLQI is a 10-item general dermatology disability index designed to assess HRQoL in adult patients with skin diseases such as eczema, psoriasis, acne and viral warts. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment and work/school.

    Each item has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions.

    Scores range from 0 to 30 and higher scores indicate greater HRQoL impairment. Additionally, each subscale of the DLQI may be analyzed separately.

  10. Incidence of AEs/SAEs

    Time frame: 52 weeks

    An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

    Serious adverse event (SAE) is defined as an AE which results in death or is life-threatening, persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant

  11. Incidence of treatment-related AEs on-treatment and post-discontinuation follow up

    Time frame: 52 weeks

    An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

  12. Incidence of unexpected treatment related AEs/SAEs on-treatment and post-discontinuation follow up

    Time frame: 52 weeks

    An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

    Serious adverse event (SAE) is defined as an AE which results in death or is life-threatening, persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant

  13. Incidence of treatment-related SAEs on-treatment and post-discontinuation follow up

    Time frame: 52 weeks

    Serious adverse event (SAE) is defined as an AE which results in death or is life-threatening, persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant

  14. Incidence of AEs of special interest on-treatment and post discontinuation follow up

    Time frame: 52 weeks

    An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

  15. Proportion of patients experiencing at least one AE

    Time frame: 52 weeks

    An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

  16. Average number of AEs per patient

    Time frame: 52 weeks

    An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

  17. Percentage of secukinumab discontinuation caused by AE

    Time frame: 52 weeks

    An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

  18. Frequency distribution of patients by dosing pattern

    Time frame: 52 weeks

    Frequency distribution of patients by dosing pattern will be collected

  19. Frequency distribution of patients by secukinumab retention

    Time frame: Week 4, week 12, week 16, week 24, week 36 and week 52

    Percentage of patients who are persistent secukinumab users or who discontinue secukinumab

  20. Mean (SD) time to secukinumab discontinuation

    Time frame: Up to 52 weeks

    Mean (SD) time to secukinumab discontinuation will be collected

  21. Median (interquartile range) time to secukinumab discontinuation

    Time frame: 52 weeks

    Median (IQR) time to secukinumab discontinuation will be collected

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Acronym: UNMASK2

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 20, 2021
Registry last updated
Mar 20, 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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