- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05650060
Characteristics of Patients Treated With Secukinumab for Moderate to Severe Plaque Psoriasis
The Characteristics of Patients Treated With Secukinumab for Moderate to Severe Plaque Psoriasis in Real-world Practice in Thailand
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bangkok, Thailand
- Novartis Investigative Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Secukinumab
all patients with psoriasis who received secukinumab
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all patients with psoriasis who received secukinumab
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Age
Time Frame: Baseline
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Age information was reported.
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Baseline
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Gender
Time Frame: Baseline
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Gender information was reported.
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Baseline
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Number of patients with Reimbursement scheme
Time Frame: Baseline
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Reimbursement scheme information was reported.
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Baseline
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Weight
Time Frame: During 3 months pre-baseline
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Weight information was reported.
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During 3 months pre-baseline
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Height
Time Frame: During 3 months pre-baseline
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Height information was reported.
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During 3 months pre-baseline
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BMI
Time Frame: During 3 months pre-baseline
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BMI information was reported.
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During 3 months pre-baseline
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Co-morbidities
Time Frame: During 12 months pre-baseline
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During 12 months pre-baseline
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Psoriasis Area and Sensitivity Index (PASI) score
Time Frame: During 4 weeks pre-baseline
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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).
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During 4 weeks pre-baseline
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Percentage of Body Surface Area (BSA) involvement
Time Frame: During 4 weeks pre-baseline
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Percentage of Body Surface Area (BSA) involvement was reported.
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During 4 weeks pre-baseline
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Disease Life Quality Index (DLQI) score
Time Frame: During 4 weeks pre-baseline
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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.
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During 4 weeks pre-baseline
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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)
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To describe the PSO treatment history
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Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
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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)
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To describe the PSO treatment history
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Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
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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)
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To describe the PSO treatment history
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Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
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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)
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To describe the PSO treatment history
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Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
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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)
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To describe the PSO treatment history
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Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
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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)
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To describe the PSO treatment history
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Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
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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)
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To describe the PSO treatment history
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Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
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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)
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To describe the PSO treatment history
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Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
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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)
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To describe the PSO treatment history
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Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
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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)
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To describe the PSO treatment history
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Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
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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)
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To describe the PSO treatment history
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Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
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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)
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To describe the PSO treatment history
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Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
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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)
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To describe the PSO treatment history
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Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
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Number of patients with baseline PSO treatment
Time Frame: During 12 months pre-baseline
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Topical Therapies
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During 12 months pre-baseline
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Duration since the discontinuation of the latest biological agents
Time Frame: Baseline
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Secukinumab therapy
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Baseline
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Medication use concomitant to index secukinumab prescription
Time Frame: Baseline
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Secukinumab therapy
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Baseline
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Treatment pattern with secukinumab
Time Frame: Baseline
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Secukinumab therapy
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Baseline
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Treatment duration since the first dosing till the most recent dosing
Time Frame: Baseline
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Secukinumab therapy
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Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAIN457ATH01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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