Moderate-to-severe Plaque PsoriasisNCT05787236
A Study of Moderate-to-severe Plaque Psoriasis Patients Response to Secukinumab Treatment in Real-world Setting
An observational study of Moderate-to-severe Plaque Psoriasis, run by Novartis Pharmaceuticals at 1 site in Indonesia.
Trial summary
This study was a one-arm, retrospective cohort study that observed clinical psoriasis patients who received secukinumab treatment in Indonesia from the 01 August 2017 until the 31 October 2020. Patients' data were obtained from the medical records of a dermatology clinic in Jakarta, Indonesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate-to-severe Plaque Psoriasis
- How many people
- 79 participants
- Where
- 1 siteIndonesia
- Study dates
- 5 Nov 2020to 15 Mar 2022
- 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 was a retrospective, noninterventional cohort study
Who may be able to join
- Male or female, aged at least 18 years old.
- Diagnosed as moderate-to-severe plaque type psoriasis with PASI score ≥ 5 prior to initiating secukinumab treatment.
- Treated with secukinumab for a minimum of 8 weeks after the initial secukinumab treatment without any interruption.
- Patients included in this study received the initial secukinumab treatment within the period of 1 August 2017 to 31 October 2019. With the secondary endpoint of 52 weeks, the latest recorded data included in the analysis was recorded on 31 October 2020.
Who cannot join
- Patients with other types of psoriasis.
- Patients with incomplete information on PASI score at Weeks 0, 8, and 16 in their medical records.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Moderate-to-severe Plaque Psoriasis Patients Response to Secukinumab Treatment in Real-world Setting: a Monocentric, Retrospective Study
This study was a one-arm, retrospective cohort study that observed clinical psoriasis patients who received secukinumab treatment in Indonesia from the 01 August 2017 until the 31 October 2020. Patients' data were obtained from the medical records of a dermatology clinic in Jakarta, Indonesia. The primary endpoints were set at Week 16, and secondary endpoints at Weeks 16 and 52. At each endpoint, the study assessed effectiveness by measuring the proportion of psoriasis patients receiving secukinumab who achieved Psoriasis Area and Severity Index (PASI) 75 (at Week 8) and PASI 90 (at Weeks 16 and 52).
- Conditions
- Moderate-to-severe Plaque Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab | Clinical psoriasis patients who received secukinumab treatment in Indonesia from 1 August 2017 to 31 October 2020. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients achieving Psoriasis Area and Severity Index (PASI) score <1, PASI score < 2, PASI score < 3, and PASI score < 5 at Week 16
The PASI is used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0.
Measured: Week 16
Secondary outcomes (8)
Percentage of patients achieving PASI 75 or higher response at Week 8
PASI 75 response was defined as ≥ 75% improvement (reduction) in PASI score compared to baseline.
Measured: Week 8
Percentage of patients achieving PASI 90 or higher response at Week 16
PASI 90 response was defined as ≥ 90% improvement (reduction) in PASI score compared to baseline.
Measured: Week 16
Percentage of patients achieving PASI 90 or higher response at Week 52
PASI 90 response was defined as ≥ 90% improvement (reduction) in PASI score compared to baseline.
Measured: Week 52
Number of injections needed to achieve at least PASI 90
PASI 90 response was defined as ≥ 90% improvement (reduction) in PASI score compared to baseline.
Measured: Weeks 16 and 52
Percentage of patients with psoriatic arthritis (PsA) who achieved at least PASI 90 at Week 16 with secukinumab
PASI 90 response was defined as ≥ 90% improvement (reduction) in PASI score compared to baseline.
Measured: Week 16
Percentage of patients with relapse event after treatment discontinuation
Measured: Up to 52 weeks
Length of remission period for patients with relapse, calculated from the last treatment date until relapse or starting recurrent symptom(s) or sign(s)
Measured: Up to 52 weeks
Percentage of patients achieving Dermatology Life Quality Index (DLQI) 0/1 at Week 52
DLQI is a ten-item general dermatology disability index designed to assess healthrelated quality of life in adult participants with skin diseases such psoriasis. It is a selfadministered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) 1 ( a little) to 3 (very much). "Not relevant" is a valid score also and is scored as 0.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start5 Nov 2020
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate-to-severe 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
- 79 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
- NCT05787236
- Sponsor's protocol ID
- CAIN457AID01
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2023
- Last updated
- 28 Mar 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderate-to-severe Plaque Psoriasis Patients Response to Secukinumab Treatment in Real-world Setting: a Monocentric, Retrospective Study
- ClinicalTrials.gov ID
- NCT05787236
- Acronym / sponsor ID
- CAIN457AID01
- Conditions
- Moderate-to-severe Plaque Psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 28 Mar 2023 (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 one-arm, retrospective cohort study that observed clinical psoriasis patients who received secukinumab treatment in Indonesia from the 01 August 2017 until the 31 October 2020. Patients' data were obtained from the medical records of a dermatology clinic in Jakarta, Indonesia. The primary endpoints were set at Week 16, and secondary endpoints at Weeks 16 and 52. At each endpoint, the study assessed effectiveness by measuring the proportion of psoriasis patients receiving secukinumab who achieved Psoriasis Area and Severity Index (PASI) 75 (at Week 8) and PASI 90 (at Weeks 16 and 52).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Secukinumab | – | –Clinical psoriasis patients who received secukinumab treatment in Indonesia from 1 August 2017 to 31 October 2020. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study
Key inclusion criteria (4 listed)
- Male or female, aged at least 18 years old.
- Diagnosed as moderate-to-severe plaque type psoriasis with PASI score ≥ 5 prior to initiating secukinumab treatment.
- Treated with secukinumab for a minimum of 8 weeks after the initial secukinumab treatment without any interruption.
- Patients included in this study received the initial secukinumab treatment within the period of 1 August 2017 to 31 October 2019. With the secondary endpoint of 52 weeks, the latest recorded data included in the analysis was recorded on 31 October 2020.
Key exclusion criteria (2 listed)
- Patients with other types of psoriasis.
- Patients with incomplete information on PASI score at Weeks 0, 8, and 16 in their medical records.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients achieving Psoriasis Area and Severity Index (PASI) score <1, PASI score < 2, PASI score < 3, and PASI score < 5 at Week 16
Time frame: Week 16
The PASI is used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0.
8 secondary outcomes
Percentage of patients achieving PASI 75 or higher response at Week 8
Time frame: Week 8
Percentage of patients achieving PASI 90 or higher response at Week 16
Time frame: Week 16
Percentage of patients achieving PASI 90 or higher response at Week 52
Time frame: Week 52
Number of injections needed to achieve at least PASI 90
Time frame: Weeks 16 and 52
Percentage of patients with psoriatic arthritis (PsA) who achieved at least PASI 90 at Week 16 with secukinumab
Time frame: Week 16
Percentage of patients with relapse event after treatment discontinuation
Time frame: Up to 52 weeks
Length of remission period for patients with relapse, calculated from the last treatment date until relapse or starting recurrent symptom(s) or sign(s)
Time frame: Up to 52 weeks
Percentage of patients achieving Dermatology Life Quality Index (DLQI) 0/1 at Week 52
Time frame: 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 28 Mar 2023.
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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 Moderate-to-severe Plaque Psoriasis, run by Novartis Pharmaceuticals at 1 site in Indonesia.
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 4 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 28 Mar 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 Indonesia. 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 achieving Psoriasis Area and Severity Index (PASI) score <1, PASI score < 2, PASI score < 3, and PASI score < 5 at Week 16 (time frame: Week 16). 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 28 Mar 2023.