Clinical trial NCT05650060: Characteristics of Patients Treated With Secukinumab for Moderate to Severe Plaque Psoriasis
Official title: The Characteristics of Patients Treated With Secukinumab for Moderate to Severe Plaque Psoriasis in Real-world Practice in Thailand
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plaque Psoriasis
Keywords: secukinumab,
psoriasis,
effectiveness,
real-world,
Thailand
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-12-14
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study was a retrospective medical chart review study. It collected the characteristics of patients who received secukinumab for the treatment of moderate to severe plaque psoriasis as the primary objective.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Age
timeFrame: Baseline
measure: Gender
timeFrame: Baseline
measure: Number of patients with Reimbursement scheme
timeFrame: Baseline
measure: Weight
timeFrame: During 3 months pre-baseline
measure: Height
timeFrame: During 3 months pre-baseline
measure: BMI
timeFrame: During 3 months pre-baseline
measure: Co-morbidities
timeFrame: During 12 months pre-baseline
measure: Psoriasis Area and Sensitivity Index (PASI) score
timeFrame: During 4 weeks pre-baseline
measure: Percentage of Body Surface Area (BSA) involvement
timeFrame: During 4 weeks pre-baseline
measure: Disease Life Quality Index (DLQI) score
timeFrame: During 4 weeks pre-baseline
measure: Date of first symptom of psoriasis (PSO) / year
timeFrame: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
measure: Date of psoriasis diagnosis / year
timeFrame: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
measure: Duration of psoriasis diagnosis
timeFrame: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
measure: Date of first systemic treatment/ year
timeFrame: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
measure: Date of first biologic agent/year
timeFrame: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
measure: Duration of topical therapy
timeFrame: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
measure: History of topical therapy
timeFrame: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
measure: Duration of systemic therapy
timeFrame: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
measure: History of systemic therapy
timeFrame: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
measure: Duration of biologic therapy
timeFrame: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
measure: History of biologic therapy
timeFrame: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
measure: Date of PsA diagnosis/year
timeFrame: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
measure: Duration of PsA diagnosis
timeFrame: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
measure: Number of patients with baseline PSO treatment
timeFrame: During 12 months pre-baseline
measure: Duration since the discontinuation of the latest biological agents
timeFrame: Baseline
measure: Medication use concomitant to index secukinumab prescription
timeFrame: Baseline
measure: Treatment pattern with secukinumab
timeFrame: Baseline
measure: Treatment duration since the first dosing till the most recent dosing
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: