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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05650060
Other study ID # CAIN457ATH01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 20, 2021
Est. completion date December 23, 2021

Study information

Verified date April 2023
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 163
Est. completion date December 23, 2021
Est. primary completion date December 23, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Secukinumab
all patients with psoriasis who received secukinumab

Locations

Country Name City State
Thailand Novartis Investigative Site Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Age Age information was reported. Baseline
Primary Gender Gender information was reported. Baseline
Primary Number of patients with Reimbursement scheme Reimbursement scheme information was reported. Baseline
Primary Weight Weight information was reported. During 3 months pre-baseline
Primary Height Height information was reported. During 3 months pre-baseline
Primary BMI BMI information was reported. During 3 months pre-baseline
Primary Co-morbidities Crohn's Disease
Diabetes Mellitus
Dyslipidemia
Hypertension
Inflammatory Bowel Disease
Latent Tuberculosis
Psoriatic Arthritis (PsA)
During 12 months pre-baseline
Primary Psoriasis Area and Sensitivity Index (PASI) score 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). During 4 weeks pre-baseline
Primary Percentage of Body Surface Area (BSA) involvement Percentage of Body Surface Area (BSA) involvement was reported. During 4 weeks pre-baseline
Primary Disease Life Quality Index (DLQI) score 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. During 4 weeks pre-baseline
Primary Date of first symptom of psoriasis (PSO) / year To describe the PSO treatment history Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
Primary Date of psoriasis diagnosis / year To describe the PSO treatment history Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
Primary Duration of psoriasis diagnosis To describe the PSO treatment history Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
Primary Date of first systemic treatment/ year To describe the PSO treatment history Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
Primary Date of first biologic agent/year To describe the PSO treatment history Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
Primary Duration of topical therapy To describe the PSO treatment history Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
Primary History of topical therapy To describe the PSO treatment history Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
Primary Duration of systemic therapy To describe the PSO treatment history Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
Primary History of systemic therapy To describe the PSO treatment history Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
Primary Duration of biologic therapy To describe the PSO treatment history Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
Primary History of biologic therapy To describe the PSO treatment history Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
Primary Date of PsA diagnosis/year To describe the PSO treatment history Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
Primary Duration of PsA diagnosis To describe the PSO treatment history Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
Primary Number of patients with baseline PSO treatment 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
During 12 months pre-baseline
Primary Duration since the discontinuation of the latest biological agents Secukinumab therapy Baseline
Primary Medication use concomitant to index secukinumab prescription Secukinumab therapy Baseline
Primary Treatment pattern with secukinumab Secukinumab therapy Baseline
Primary Treatment duration since the first dosing till the most recent dosing Secukinumab therapy Baseline
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