Plaque PsoriasisNCT05344482
Evaluation of the Effectiveness of Secukinumab in Patients With Moderate to Severe Plaque Psoriasis
An observational study of Plaque Psoriasis, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This study was a real-life study which was based on secondary data collection from the electronic or paper medical records from the Dermatology Clinics of the 14 University, Training \& Research Hospitals in Turkey. Data were extracted between 02 September 2020 and 29 April 2021. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Secukinumab
- How many people
- 277 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2020to 31 Aug 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of adults diagnosed as chronic plaque psoriasis with no previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA, whose PASI score was ≥10 before initiation of secukinumab in whom secukinumab had been initiated for at least 52 weeks before data collection date.
Who may be able to join
- A diagnosis of psoriasis
- Age ≥ 18 years at registry baseline.
- Patients with a firm diagnosis of chronic plaque psoriasis for at least 6 months before enrollment
- Secukinumab treatment should be initiated 52 weeks before data collection date
- Moderate to severe plaque psoriasis with PASI score of ≥10 before initiating secukinumab.
Who cannot join
- Patients diagnosed with others types of psoriasis (pustular psoriasis, erythrodermic psoriasis etc) are excluded.
- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
East Hanover, New Jersey, 07936-1080
About this study
Official title: A Retrospective Multicenter Study for the Assessment of Effectiveness of Secukinumab as Assessed by Psoriasis Area and Severity Index With Subcutaneous Administration in Adult Patients With Moderate to Severe Plaque Psoriasis in Turkish Population
This study was a real-life study which was based on secondary data collection from the electronic or paper medical records from the Dermatology Clinics of the 14 University, Training \& Research Hospitals in Turkey. Data were extracted between 02 September 2020 and 29 April 2021.
Read the detailed description
The study was a retrospective, multicenter, cohort study which was based on data collection at week 4,16 and 52 of secukinumab treatment of moderate to severe plaque psoriasis.
The observational design of the study allowed data collection about secukinumab treatment patterns and clinical and demographic characteristics of plaque psoriasis patients treated with secukinumab for 52 weeks in Turkey. The adults included in the study were treated with secukinumab for 52 weeks. The adults with no available data of PASI scores at specific time points (4, 16 and 52 weeks) and no definite description of treatment cessation were excluded. The study population consisted of adults treated with secukinumab for 52 weeks and adults dropped out before 52 weeks with available data of PASI scores at 4, 16 and 52 weeks and definite description of treatment cessation.
Retrospective data collection from secondary sources (hospital medical records) allowed time and cost saving since description of patients' characteristics, analyses of outcomes of interest and their determinants could be made in a short period of time.
The study consisted of the following periods:
- The index date was the date of initiation of secukinumab
- The study (index) period was between 18 May 2018 to 31 May 2020
- The follow-up (post-index) period was 4,16 and 52 weeks post-index
- Conditions
- Plaque Psoriasis
- Being tested
- Secukinumab
- Keywords
- Secukinumab,, real life,, PASI,, effectiveness,, anti-IL17
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabOther
Included all the patients treated with secukinumab
| Study group | Role | What they receive |
|---|---|---|
| Overall cohort: Secukinumab | Included all the patients treated with secukinumab Receives: Other: Secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients having absolute Psoriasis Area and Severity Index PASI≤3 at week 52
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). Assessment of the effectiveness of secukinumab in subjects with moderate to severe plaque psoriasis was performed based on the percentage of patients who had absolute PASI ≤3 at week 52 in Turkey.
Measured: at week 52
Secondary outcomes (13)
Percentage of patients experiencing a 75% reduction in PASI (PASI75) from baseline
Speed of response to secukinumab according to previous biologic use was demonstrated.
Measured: at week 4
Percentage of patients experiencing a 75% reduction in PASI (PASI90) from baseline
Speed of response to secukinumab according to previous biologic use was demonstrated.
Measured: at week 16
Percentage of PASI 90 responders at week 52 out of PASI 90 responders at week 16
Sustainability rate between week 16 and week 52 which is defined as PASI 90 scores at both milestones was assessed.
Measured: at week 16 and week 52
Percentage of patients experiencing a 100% reduction in PASI (PASI100) from baseline
PASI 100 responders rate at week 52 was assessed.
Measured: at week 52
Percentage of PASI 90 responders among biologic naive patients vs. biologic experienced patients
Responders rates for biologic naive vs. non-naive patients in terms of PASI 90 at week 52 was evaluated.
Measured: at week 52
Percentage of PASI 90 responder rates at week 52 among smokers vs. non-smokers
Effect of secukinumab treatment response for psoriasis patients (between smokers vs. non-smokers) at week 52 was assessed
Measured: at week 52
Percentage of PASI 75 responder rates among very severe (PASI>20) patients prior the treatment
Effectiveness of secukinumab treatment for very severe ( PASI>20 ) psoriatic patients at week 52 was demonstrated.
Measured: at week 52
Nail psoriasis: percentage of patients experiencing nail psoriasis, number of finger nails involved
Effectiveness of secukinumab in psoriatic manifestations was demonstrated.
Measured: at week 52
Palmoplantar psoriasis: percentage of patients experiencing palmoplantar psoriasis
Effectiveness of secukinumab in psoriatic manifestations was demonstrated.
Measured: at week 52
Scalp psoriasis: percentage of patients experiencing scalp psoriasis
Effectiveness of secukinumab in psoriatic manifestations was demonstrated.
Measured: at week 52
Psoriatic arthritis: percentage of patients experiencing psoriatic arthritis
Effectiveness of secukinumab in psoriatic manifestations was demonstrated.
Measured: at week 52
Percentage of patients who discontinued secukinumab at 52 weeks period
Drug survival as measured by percentage of patients who were persistent secukinumab users, or percentage of patients who discontinued secukinumab at 52 weeks period was reported to describe secukinumab treatment utilization patterns.
Measured: at week 52
Time to discontinuation
Time to discontinuation defined as time from treatment initiation to treatment stop. For patients who stopped secukinumab but re initiated treatment within 90 days after stop date without any other systemic treatment in between will be considered as continued/persistent users.
Measured: at week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start9 Jul 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 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
- 277 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
- NCT05344482
- Sponsor's protocol ID
- CAIN457ATR02
- Status last verified
- Jun 2022
- First submitted
- 19 Apr 2022
- Last updated
- 1 Jul 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Multicenter Study for the Assessment of Effectiveness of Secukinumab as Assessed by Psoriasis Area and Severity Index With Subcutaneous Administration in Adult Patients With Moderate to Severe Plaque Psoriasis in Turkish Population
- ClinicalTrials.gov ID
- NCT05344482
- Acronym / sponsor ID
- CAIN457ATR02
- Conditions
- Plaque Psoriasis
- Keywords
- Secukinumab,, real life,, PASI,, effectiveness,, anti-IL17
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 25 Apr 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 real-life study which was based on secondary data collection from the electronic or paper medical records from the Dermatology Clinics of the 14 University, Training \& Research Hospitals in Turkey. Data were extracted between 02 September 2020 and 29 April 2021.
Detailed description
The study was a retrospective, multicenter, cohort study which was based on data collection at week 4,16 and 52 of secukinumab treatment of moderate to severe plaque psoriasis.
The observational design of the study allowed data collection about secukinumab treatment patterns and clinical and demographic characteristics of plaque psoriasis patients treated with secukinumab for 52 weeks in Turkey. The adults included in the study were treated with secukinumab for 52 weeks. The adults with no available data of PASI scores at specific time points (4, 16 and 52 weeks) and no definite description of treatment cessation were excluded. The study population consisted of adults treated with secukinumab for 52 weeks and adults dropped out before 52 weeks with available data of PASI scores at 4, 16 and 52 weeks and definite description of treatment cessation.
Retrospective data collection from secondary sources (hospital medical records) allowed time and cost saving since description of patients' characteristics, analyses of outcomes of interest and their determinants could be made in a short period of time.
The study consisted of the following periods:
- The index date was the date of initiation of secukinumab
- The study (index) period was between 18 May 2018 to 31 May 2020
- The follow-up (post-index) period was 4,16 and 52 weeks post-index
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overall cohort: Secukinumab | – | Other: SecukinumabIncluded all the patients treated with secukinumab |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adults diagnosed as chronic plaque psoriasis with no previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA, whose PASI score was ≥10 before initiation of secukinumab in whom secukinumab had been initiated for at least 52 weeks before data collection date.
Key inclusion criteria (5 listed)
- A diagnosis of psoriasis
- Age ≥ 18 years at registry baseline.
- Patients with a firm diagnosis of chronic plaque psoriasis for at least 6 months before enrollment
- Secukinumab treatment should be initiated 52 weeks before data collection date
- Moderate to severe plaque psoriasis with PASI score of ≥10 before initiating secukinumab.
Key exclusion criteria (2 listed)
- Patients diagnosed with others types of psoriasis (pustular psoriasis, erythrodermic psoriasis etc) are excluded.
- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA
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 |
|---|---|---|
| SecukinumabIncluded all the patients treated with secukinumab | Other | Overall cohort: Secukinumab |
Primary outcome
Percentage of patients having absolute Psoriasis Area and Severity Index PASI≤3 at week 52
Time frame: at week 52
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). Assessment of the effectiveness of secukinumab in subjects with moderate to severe plaque psoriasis was performed based on the percentage of patients who had absolute PASI ≤3 at week 52 in Turkey.
13 secondary outcomes
Percentage of patients experiencing a 75% reduction in PASI (PASI75) from baseline
Time frame: at week 4
Percentage of patients experiencing a 75% reduction in PASI (PASI90) from baseline
Time frame: at week 16
Percentage of PASI 90 responders at week 52 out of PASI 90 responders at week 16
Time frame: at week 16 and week 52
Percentage of patients experiencing a 100% reduction in PASI (PASI100) from baseline
Time frame: at week 52
Percentage of PASI 90 responders among biologic naive patients vs. biologic experienced patients
Time frame: at week 52
Percentage of PASI 90 responder rates at week 52 among smokers vs. non-smokers
Time frame: at week 52
Percentage of PASI 75 responder rates among very severe (PASI>20) patients prior the treatment
Time frame: at week 52
Nail psoriasis: percentage of patients experiencing nail psoriasis, number of finger nails involved
Time frame: at week 52
Palmoplantar psoriasis: percentage of patients experiencing palmoplantar psoriasis
Time frame: at week 52
Scalp psoriasis: percentage of patients experiencing scalp psoriasis
Time frame: at week 52
Psoriatic arthritis: percentage of patients experiencing psoriatic arthritis
Time frame: at week 52
Percentage of patients who discontinued secukinumab at 52 weeks period
Time frame: at week 52
Time to discontinuation
Time frame: at week 52
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 1 Jul 2022.
- Results for CAIN457ATR02 from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
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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 United States.
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 5 inclusion and 2 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 1 Jul 2022. 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 United States. 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?
Percentage of patients having absolute Psoriasis Area and Severity Index PASI≤3 at week 52 (time frame: at week 52). 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 1 Jul 2022.