Plaque PsoriasisNCT05650060
Characteristics of Patients Treated With Secukinumab for Moderate to Severe Plaque Psoriasis
An observational study of Plaque Psoriasis, run by Novartis Pharmaceuticals at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Secukinumab
- How many people
- 163 participants
- Where
- 1 siteThailand
- Study dates
- 20 Jan 2021to 23 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients diagnosed with other forms of psoriasis other than plaque-type
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Characteristics of Patients Treated With Secukinumab for Moderate to Severe Plaque Psoriasis in Real-world Practice in Thailand
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.
Read the 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.
- Conditions
- Plaque Psoriasis
- Being tested
- Secukinumab
- Keywords
- secukinumab,, psoriasis,, effectiveness,, real-world,, Thailand
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabDrug
all patients with psoriasis who received secukinumab
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab | all patients with psoriasis who received secukinumab Receives: Drug: Secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
Age information was reported.
Measured: Baseline
Gender
Gender information was reported.
Measured: Baseline
Number of patients with Reimbursement scheme
Reimbursement scheme information was reported.
Measured: Baseline
Weight
Weight information was reported.
Measured: During 3 months pre-baseline
Height
Height information was reported.
Measured: During 3 months pre-baseline
BMI
BMI information was reported.
Measured: During 3 months pre-baseline
Co-morbidities
- Crohn's Disease
- Diabetes Mellitus
- Dyslipidemia
- Hypertension
- Inflammatory Bowel Disease
- Latent Tuberculosis
- Psoriatic Arthritis (PsA)
Measured: During 12 months pre-baseline
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).
Measured: During 4 weeks pre-baseline
Percentage of Body Surface Area (BSA) involvement
Percentage of Body Surface Area (BSA) involvement was reported.
Measured: During 4 weeks pre-baseline
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.
Measured: During 4 weeks pre-baseline
Date of first symptom of psoriasis (PSO) / year
To describe the PSO treatment history
Measured: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
Date of psoriasis diagnosis / year
To describe the PSO treatment history
Measured: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
Duration of psoriasis diagnosis
To describe the PSO treatment history
Measured: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
Date of first systemic treatment/ year
To describe the PSO treatment history
Measured: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
Date of first biologic agent/year
To describe the PSO treatment history
Measured: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
Duration of topical therapy
To describe the PSO treatment history
Measured: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
History of topical therapy
To describe the PSO treatment history
Measured: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
Duration of systemic therapy
To describe the PSO treatment history
Measured: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
History of systemic therapy
To describe the PSO treatment history
Measured: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
Duration of biologic therapy
To describe the PSO treatment history
Measured: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
History of biologic therapy
To describe the PSO treatment history
Measured: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
Date of PsA diagnosis/year
To describe the PSO treatment history
Measured: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
Duration of PsA diagnosis
To describe the PSO treatment history
Measured: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
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
Measured: During 12 months pre-baseline
Duration since the discontinuation of the latest biological agents
Secukinumab therapy
Measured: Baseline
Medication use concomitant to index secukinumab prescription
Secukinumab therapy
Measured: Baseline
Treatment pattern with secukinumab
Secukinumab therapy
Measured: Baseline
Treatment duration since the first dosing till the most recent dosing
Secukinumab therapy
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start20 Jan 2021
- Primary completion23 Dec 2021
- Study completion23 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650060
- Sponsor's protocol ID
- CAIN457ATH01
- Status last verified
- Apr 2023
- First submitted
- 6 Dec 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Characteristics of Patients Treated With Secukinumab for Moderate to Severe Plaque Psoriasis in Real-world Practice in Thailand
- ClinicalTrials.gov ID
- NCT05650060
- Acronym / sponsor ID
- CAIN457ATH01
- Conditions
- Plaque Psoriasis
- Keywords
- secukinumab,, psoriasis,, effectiveness,, real-world,, Thailand
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Secukinumab | – | Drug: Secukinumaball patients with psoriasis who received secukinumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients diagnosed with other forms of psoriasis other than plaque-type
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Secukinumaball patients with psoriasis who received secukinumab | Drug | Secukinumab |
Primary outcome
Age
Time frame: Baseline
Age information was reported.
Gender
Time frame: Baseline
Gender information was reported.
Number of patients with Reimbursement scheme
Time frame: Baseline
Reimbursement scheme information was reported.
Weight
Time frame: During 3 months pre-baseline
Weight information was reported.
Height
Time frame: During 3 months pre-baseline
Height information was reported.
BMI
Time frame: During 3 months pre-baseline
BMI information was reported.
Co-morbidities
Time frame: During 12 months pre-baseline
* Crohn's Disease * Diabetes Mellitus * Dyslipidemia * Hypertension * Inflammatory Bowel Disease * Latent Tuberculosis * Psoriatic Arthritis (PsA)
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).
Percentage of Body Surface Area (BSA) involvement
Time frame: During 4 weeks pre-baseline
Percentage of Body Surface Area (BSA) involvement was reported.
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Duration since the discontinuation of the latest biological agents
Time frame: Baseline
Secukinumab therapy
Medication use concomitant to index secukinumab prescription
Time frame: Baseline
Secukinumab therapy
Treatment pattern with secukinumab
Time frame: Baseline
Secukinumab therapy
Treatment duration since the first dosing till the most recent dosing
Time frame: Baseline
Secukinumab therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plaque Psoriasis, run by Novartis Pharmaceuticals at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age (time frame: Baseline). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.