PsoriasisNCT05513014
Impact of Secukinumab on Clinical and Patient Reported Outcomes in Patients With Psoriasis
An observational study of Psoriasis, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
The study was conducted to describe the demographics, disease characteristics, disease severity, comorbidities and patient reported outcomes at baseline and follow-up periods among adult patients diagnosed with PsO in CorEvitas' PsO Registry under routine medical care initiating secukinumab (SEC). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Secukinumab
- How many people
- 1,518 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2021to 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with psoriasis who initiated Secukinumab
Who may be able to join
- The patient must:
- Have been diagnosed with PsO by a dermatologist.
- Be at least 18 years of age.
- Be willing and able to provide written informed consent for participation in the registry.
- Have started on or switched to an eligible systemic PsO treatment at enrollment1 or within the previous 12 months of the date of enrollment.
Who cannot join
- Patient is participating in or planning to participate in an interventional clinical trial with a nonmarketed or marketed investigational drug (i.e. phase I-IV drug trial).
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936-1080
About this study
Official title: Impact of Secukinumab on Clinical and Patient Reported Outcomes in Patients With Psoriasis in a Real World Setting in the US (Bionaive Secukinumab Users NVS 521)
The study was conducted to describe the demographics, disease characteristics, disease severity, comorbidities and patient reported outcomes at baseline and follow-up periods among adult patients diagnosed with PsO in CorEvitas' PsO Registry under routine medical care initiating secukinumab (SEC).
Read the detailed description
This is a retrospective analysis of a prospective observational cohort using CorEvitas' PsO registry of adult PsO patients. This study describes clinical and patient reported outcomes among adult patients initiating Secukinumab (SEC). Biologic experienced and naïve patients are examined separately. This study also describes changes in clinical and patient reported outcomes over time.
CorEvitas' Psoriasis Registry is a prospective, observational cohort of adult PsO patients starting systemic therapy, launched in April 2015 with sites in the US and Canada. Data collection occurs every ~6 months at routine dermatology visits. This study included US PsO patients who initiated secukinumab at or after enrollment and had a subsequent 6- and/or 12-month follow-up visit (Apr 2015 to Dec 2020).The index date is defined as the date of the first SEC initiation at or after enrollment.
- Conditions
- Psoriasis
- Being tested
- Secukinumab
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabDrug
Patients with Psoriasis who initiated Secukinumab
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab: Overall Cohort | Patients with Psoriasis who initiated Secukinumab Receives: Drug: Secukinumab | |
| Biologic Experienced | Patients who had the history of use of ≥1 biologic medication for the treatment of PsO at the time of SEC initiation | |
| Biologic Naive | Patients who had no history of use of biologic medication for the treatment of PsO at the time of SEC initiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
Age was reported to describe the sociodemographic characteristics of the patients.
Measured: Baseline
Gender
Gender was reported to describe the sociodemographic characteristics of the patients.
Measured: Baseline
Race
Race was reported to describe the sociodemographic characteristics of the patients.
Measured: Baseline
Ethnicity
Ethnicity was reported to describe the sociodemographic characteristics of the patients.
Measured: Baseline
Body weight
Body weight was reported to describe the sociodemographic characteristics of the patients.
Measured: Baseline
Number of patients: Weight category
Number of patients with Weight category were reported to describe the sociodemographic characteristics of the patients.
Measured: Baseline
Number of patients: CDC BMI categories
Number of patients with CDC BMI categories were reported to describe the sociodemographic characteristics of the patients.
Measured: Baseline
Number of patients: Smoking history
Number of patients with Smoking history were reported to describe the sociodemographic characteristics of the patients.
Measured: Baseline
Number of patients: Alcohol use history
Number of patients with Alcohol use history were reported to describe the sociodemographic characteristics of the patients.
Measured: Baseline
Number of patients: Insurance type
Number of patients with Insurance type were reported to describe the sociodemographic characteristics of the patients.
Measured: Baseline
Number of patients: Provider region (US Census Bureau)
Number of patients with Provider region (US Census Bureau) were reported to describe the sociodemographic characteristics of the patients.
Measured: Baseline
Psoriasis duration
Psoriasis duration was reported to describe the Disease characteristics of the patients.
Measured: Baseline
Age at onset of PsO symptoms
Age at onset of PsO symptoms was reported to describe the Disease characteristics of the patients.
Measured: Baseline
Number of patients: Morphology
Number of patients with Morphology were reported to describe the disease characteristics of the patients.
Measured: Baseline
Number of patients: Comorbid psoriatic arthritis (PsA)
Number of patients with Comorbid psoriatic arthritis (PsA) were reported to describe the disease characteristics of the patients.
Measured: Baseline
Psoriatic arthritis duration
Psoriatic arthritis duration was reported to describe the Disease characteristics of the patients.
Measured: Baseline
Number of patients: History of comorbidities/toxicities
Number of patients with History of comorbidities/toxicities were reported to describe the disease characteristics of the patients.
Measured: Baseline
Number of patients: History of IBD
Number of patients with History of IBD were reported to describe the disease characteristics of the patients.
Measured: Baseline
Number of patients: Any infection
Number of patients with any infection were reported to describe the disease characteristics of the patients.
Measured: Baseline
Dermatology Life Quality Index (DLQI) (Score: 0-30)
The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Measured: Baseline
Number of patients: DLQI: Effect on life
The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Measured: Baseline
Patient global assessment (PGA)
The PGA scoring system is based on response to treatment as measured by lesion erythema, induration, and scale, with score assignments that range from clear, almost clear, mild, moderate, to severe.
Measured: Baseline
Patient itch assessment (VAS: 0-100)
Patient itch assessment was reported to evaluate overall, how severe was the itch from psoriasis in the past week. The score ranged from 0 to 100, where negative change indicated that the score declined over time.
Measured: Baseline
Patient fatigue assessment (VAS: 0-100)
Patient fatigue assessment was reported to evaluate overall, how severe was the fatigue from psoriasis in the past week. The score ranged from 0 to 100, where negative change indicated that the score declined over time.
Measured: Baseline
Patient skin pain assessment (VAS: 0-100)
Patient skin pain assessment was reported to evaluate overall, how severe was the skin pain from psoriasis in the past week. The score ranged from 0 to 100, where negative change indicated that the score declined over time.
Measured: Baseline
Patient health state today (EQ-5D VAS: 0-100)
Questions: Given questions in the following 5 dimensions: (a) mobility, (b) self-care, (c) usual activities, (d) pain/discomfort and (e) anxiety/depression.
With each dimension scored in 3 levels: 1 = {(a)-(c) =No problems, (d)=No pain, (e)=Not anxious or depressed}; 2 = {(a)-(c) = Some problems, (d) = Moderate pain or discomfort, (e ) = Moderately anxious or depressed}; 3={(a) = Confined to bed, (b)-(c)= Unable to do, (d) = Extreme pain or discomfort, (e) = Extremely anxious or depressed} With each dimension scored in 5 levels: 1 = No problems, 2 = Slight problems, 3 = Moderate problems, 4 = Severe problems, 5 = Extreme problems.
Measured: Baseline
Number of patients: Mobility problems
Included the following: No problems, some problems, confined to bed
Measured: Baseline
Number of patients: Self-care problems
Included the following: No problems, some problems, unable
Measured: Baseline
Number of patients: Usual activities problems
Included the following: No problems
Measured: Baseline
Number of patients: Some problems
Included the following: Unable
Measured: Baseline
Number of patients: Pain or discomfort
Included the following: None, moderate and extreme
Measured: Baseline
Number of patients: Work Productivity and Activity Impairment Questionnaire (WPAI) (0 to 100%)
Questions:1 = Currently employed? 2 = Hours missed due to psoriasis? 3 = Hours missed other reasons? 4 = Hours actually worked? 5 = Degree problem affected productivity while working (VAS (0 to 100) measurement)? 6 = Degree problem affected regular activities (VAS (0 to 100) measurement)? Scores: Multiply scores by 100 to express in percentages for reported categories: Percent work time missed due to problem: Q2/(Q2+Q4) Percent impairment while working due to problem: Q5/10 Percent overall work impairment due to problem: Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4)))x(Q5/10)] Percent activity impairment due to problem: Q6/10
Measured: Baseline
PASI (Score: 0-72)
PASI (Score: 0-72) was reported to describe the PsO Specific Measures of the patients.
Measured: Baseline
BSA (% involvement)
BSA (% involvement) was reported to describe the PsO Specific Measures of the patients.
Measured: Baseline
Number of patients: BSA categorical
Number of patients with BSA categorical were reported to describe the PsO Specific Measures of the patients.
Measured: Baseline
Number of patients: Investigator Global Assessment
Number of patients with Investigator Global Assessment were reported to describe the PsO Specific Measures of the patients.
Measured: Baseline
Number of patients: PEST Score
Number of patients with PEST Score were reported to describe the PsO Specific Measures of the patients.
Measured: Baseline
Number of patients: Therapies - Prior and Concomitant Drugs
Included the following:
Unique prior biologic count Prior biologic exposures Unique prior non-biologic count Prior non-biologic exposures Nonbiologic naïve Current or prior topical use Concomitant non-biologic systemics
Measured: Baseline
Number of patients: Primary reason for SEC initiation
Number of patients with Primary reason for SEC initiation
Measured: Baseline
Secondary outcomes (10)
Change from baseline in Investigator Global Assessment (IGA)
Changes in continuous outcomes between baseline, 6 and 12 month follow-up visit among patients remaining on SEC at 6 and 12 months, by prior biologic use.
Measured: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in PASI (Score: 0-72)
Changes in continuous outcomes between baseline, 6 and 12 month follow-up visit among patients remaining on SEC at 6 and 12 months, by prior biologic use.
Measured: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in BSA (% involvement)
Changes in continuous outcomes between baseline, 6 and 12 month follow-up visit among patients remaining on SEC at 6 and 12 months, by prior biologic use.
Measured: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in Patient health state today (EQ-5D VAS: 0-100)
Changes in continuous outcomes between baseline, 6 and 12 month follow-up visit among patients remaining on SEC at 6 and 12 months, by prior biologic use.
Measured: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in WPAI summary scores
Changes in continuous outcomes between baseline, 6 and 12 month follow-up visit among patients remaining on SEC at 6 and 12 months, by prior biologic use.
Measured: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in DLQI (Score: 0-30)
Changes in continuous outcomes between baseline, 6 and 12 month follow-up visit among patients remaining on SEC at 6 and 12 months, by prior biologic use.
The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Measured: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in Patient global assessment
Changes in continuous outcomes between baseline, 6 and 12 month follow-up visit among patients remaining on SEC at 6 and 12 months, by prior biologic use.
The PGA scoring system is based on response to treatment as measured by lesion erythema, induration, and scale, with score assignments that range from clear, almost clear, mild, moderate, to severe.
Measured: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in Patient itch assessment (VAS: 0-100)
Changes in continuous outcomes between baseline, 6 and 12 month follow-up visit among patients remaining on SEC at 6 and 12 months, by prior biologic use.
Patient itch assessment was reported to evaluate overall, how severe was the itch from psoriasis in the past week. The score ranged from 0 to 100, where negative change indicated that the score declined over time.
Measured: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in Patient fatigue assessment (VAS: 0-100)
Changes in continuous outcomes between baseline, 6 and 12 month follow-up visit among patients remaining on SEC at 6 and 12 months, by prior biologic use.
Patient fatigue assessment was reported to evaluate overall, how severe was the fatigue from psoriasis in the past week. The score ranged from 0 to 100, where negative change indicated that the score declined over time.
Measured: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in Patient skin pain assessment (VAS: 0-100)
Changes in continuous outcomes between baseline, 6 and 12 month follow-up visit among patients remaining on SEC at 6 and 12 months, by prior biologic use.
Patient skin pain assessment was reported to evaluate overall, how severe was the skin pain from psoriasis in the past week. The score ranged from 0 to 100, where negative change indicated that the score declined over time.
Measured: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start21 Mar 2021
- 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 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
- 1,518 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
- NCT05513014
- Sponsor's protocol ID
- CAIN457AUS31
- Status last verified
- Nov 2022
- First submitted
- 22 Aug 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Secukinumab on Clinical and Patient Reported Outcomes in Patients With Psoriasis in a Real World Setting in the US (Bionaive Secukinumab Users NVS 521)
- ClinicalTrials.gov ID
- NCT05513014
- Acronym / sponsor ID
- CAIN457AUS31
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,518 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 23 Aug 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.
The study was conducted to describe the demographics, disease characteristics, disease severity, comorbidities and patient reported outcomes at baseline and follow-up periods among adult patients diagnosed with PsO in CorEvitas' PsO Registry under routine medical care initiating secukinumab (SEC).
Detailed description
This is a retrospective analysis of a prospective observational cohort using CorEvitas' PsO registry of adult PsO patients. This study describes clinical and patient reported outcomes among adult patients initiating Secukinumab (SEC). Biologic experienced and naïve patients are examined separately. This study also describes changes in clinical and patient reported outcomes over time.
CorEvitas' Psoriasis Registry is a prospective, observational cohort of adult PsO patients starting systemic therapy, launched in April 2015 with sites in the US and Canada. Data collection occurs every ~6 months at routine dermatology visits. This study included US PsO patients who initiated secukinumab at or after enrollment and had a subsequent 6- and/or 12-month follow-up visit (Apr 2015 to Dec 2020).The index date is defined as the date of the first SEC initiation at or after enrollment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Secukinumab: Overall Cohort | – | Drug: SecukinumabPatients with Psoriasis who initiated Secukinumab |
| Biologic Experienced | – | –Patients who had the history of use of ≥1 biologic medication for the treatment of PsO at the time of SEC initiation |
| Biologic Naive | – | –Patients who had no history of use of biologic medication for the treatment of PsO at the time of SEC initiation |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with psoriasis who initiated Secukinumab
Key inclusion criteria (5 listed)
- Have been diagnosed with PsO by a dermatologist.
- Be at least 18 years of age.
- Be willing and able to provide written informed consent for participation in the registry.
- Have started on or switched to an eligible systemic PsO treatment at enrollment1 or within the previous 12 months of the date of enrollment.
Key exclusion criteria (1 listed)
- Patient is participating in or planning to participate in an interventional clinical trial with a nonmarketed or marketed investigational drug (i.e. phase I-IV drug trial).
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 |
|---|---|---|
| SecukinumabPatients with Psoriasis who initiated Secukinumab | Drug | Secukinumab: Overall Cohort |
Primary outcome
Age
Time frame: Baseline
Age was reported to describe the sociodemographic characteristics of the patients.
Gender
Time frame: Baseline
Gender was reported to describe the sociodemographic characteristics of the patients.
Race
Time frame: Baseline
Race was reported to describe the sociodemographic characteristics of the patients.
Ethnicity
Time frame: Baseline
Ethnicity was reported to describe the sociodemographic characteristics of the patients.
Body weight
Time frame: Baseline
Body weight was reported to describe the sociodemographic characteristics of the patients.
Number of patients: Weight category
Time frame: Baseline
Number of patients with Weight category were reported to describe the sociodemographic characteristics of the patients.
Number of patients: CDC BMI categories
Time frame: Baseline
Number of patients with CDC BMI categories were reported to describe the sociodemographic characteristics of the patients.
Number of patients: Smoking history
Time frame: Baseline
Number of patients with Smoking history were reported to describe the sociodemographic characteristics of the patients.
Number of patients: Alcohol use history
Time frame: Baseline
Number of patients with Alcohol use history were reported to describe the sociodemographic characteristics of the patients.
Number of patients: Insurance type
Time frame: Baseline
Number of patients with Insurance type were reported to describe the sociodemographic characteristics of the patients.
Number of patients: Provider region (US Census Bureau)
Time frame: Baseline
Number of patients with Provider region (US Census Bureau) were reported to describe the sociodemographic characteristics of the patients.
Psoriasis duration
Time frame: Baseline
Psoriasis duration was reported to describe the Disease characteristics of the patients.
Age at onset of PsO symptoms
Time frame: Baseline
Age at onset of PsO symptoms was reported to describe the Disease characteristics of the patients.
Number of patients: Morphology
Time frame: Baseline
Number of patients with Morphology were reported to describe the disease characteristics of the patients.
Number of patients: Comorbid psoriatic arthritis (PsA)
Time frame: Baseline
Number of patients with Comorbid psoriatic arthritis (PsA) were reported to describe the disease characteristics of the patients.
Psoriatic arthritis duration
Time frame: Baseline
Psoriatic arthritis duration was reported to describe the Disease characteristics of the patients.
Number of patients: History of comorbidities/toxicities
Time frame: Baseline
Number of patients with History of comorbidities/toxicities were reported to describe the disease characteristics of the patients.
Number of patients: History of IBD
Time frame: Baseline
Number of patients with History of IBD were reported to describe the disease characteristics of the patients.
Number of patients: Any infection
Time frame: Baseline
Number of patients with any infection were reported to describe the disease characteristics of the patients.
Dermatology Life Quality Index (DLQI) (Score: 0-30)
Time frame: Baseline
The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Number of patients: DLQI: Effect on life
Time frame: Baseline
The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Patient global assessment (PGA)
Time frame: Baseline
The PGA scoring system is based on response to treatment as measured by lesion erythema, induration, and scale, with score assignments that range from clear, almost clear, mild, moderate, to severe.
Patient itch assessment (VAS: 0-100)
Time frame: Baseline
Patient itch assessment was reported to evaluate overall, how severe was the itch from psoriasis in the past week. The score ranged from 0 to 100, where negative change indicated that the score declined over time.
Patient fatigue assessment (VAS: 0-100)
Time frame: Baseline
Patient fatigue assessment was reported to evaluate overall, how severe was the fatigue from psoriasis in the past week. The score ranged from 0 to 100, where negative change indicated that the score declined over time.
Patient skin pain assessment (VAS: 0-100)
Time frame: Baseline
Patient skin pain assessment was reported to evaluate overall, how severe was the skin pain from psoriasis in the past week. The score ranged from 0 to 100, where negative change indicated that the score declined over time.
Patient health state today (EQ-5D VAS: 0-100)
Time frame: Baseline
Questions: Given questions in the following 5 dimensions: (a) mobility, (b) self-care, (c) usual activities, (d) pain/discomfort and (e) anxiety/depression. With each dimension scored in 3 levels: 1 = {(a)-(c) =No problems, (d)=No pain, (e)=Not anxious or depressed}; 2 = {(a)-(c) = Some problems, (d) = Moderate pain or discomfort, (e ) = Moderately anxious or depressed}; 3={(a) = Confined to bed, (b)-(c)= Unable to do, (d) = Extreme pain or discomfort, (e) = Extremely anxious or depressed} With each dimension scored in 5 levels: 1 = No problems, 2 = Slight problems, 3 = Moderate problems, 4 = Severe problems, 5 = Extreme problems.
Number of patients: Mobility problems
Time frame: Baseline
Included the following: No problems, some problems, confined to bed
Number of patients: Self-care problems
Time frame: Baseline
Included the following: No problems, some problems, unable
Number of patients: Usual activities problems
Time frame: Baseline
Included the following: No problems
Number of patients: Some problems
Time frame: Baseline
Included the following: Unable
Number of patients: Pain or discomfort
Time frame: Baseline
Included the following: None, moderate and extreme
Number of patients: Work Productivity and Activity Impairment Questionnaire (WPAI) (0 to 100%)
Time frame: Baseline
Questions:1 = Currently employed? 2 = Hours missed due to psoriasis? 3 = Hours missed other reasons? 4 = Hours actually worked? 5 = Degree problem affected productivity while working (VAS (0 to 100) measurement)? 6 = Degree problem affected regular activities (VAS (0 to 100) measurement)? Scores: Multiply scores by 100 to express in percentages for reported categories: Percent work time missed due to problem: Q2/(Q2+Q4) Percent impairment while working due to problem: Q5/10 Percent overall work impairment due to problem: Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4)))x(Q5/10)] Percent activity impairment due to problem: Q6/10
PASI (Score: 0-72)
Time frame: Baseline
PASI (Score: 0-72) was reported to describe the PsO Specific Measures of the patients.
BSA (% involvement)
Time frame: Baseline
BSA (% involvement) was reported to describe the PsO Specific Measures of the patients.
Number of patients: BSA categorical
Time frame: Baseline
Number of patients with BSA categorical were reported to describe the PsO Specific Measures of the patients.
Number of patients: Investigator Global Assessment
Time frame: Baseline
Number of patients with Investigator Global Assessment were reported to describe the PsO Specific Measures of the patients.
Number of patients: PEST Score
Time frame: Baseline
Number of patients with PEST Score were reported to describe the PsO Specific Measures of the patients.
Number of patients: Therapies - Prior and Concomitant Drugs
Time frame: Baseline
Included the following: Unique prior biologic count Prior biologic exposures Unique prior non-biologic count Prior non-biologic exposures Nonbiologic naïve Current or prior topical use Concomitant non-biologic systemics
Number of patients: Primary reason for SEC initiation
Time frame: Baseline
Number of patients with Primary reason for SEC initiation
10 secondary outcomes
Change from baseline in Investigator Global Assessment (IGA)
Time frame: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in PASI (Score: 0-72)
Time frame: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in BSA (% involvement)
Time frame: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in Patient health state today (EQ-5D VAS: 0-100)
Time frame: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in WPAI summary scores
Time frame: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in DLQI (Score: 0-30)
Time frame: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in Patient global assessment
Time frame: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in Patient itch assessment (VAS: 0-100)
Time frame: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in Patient fatigue assessment (VAS: 0-100)
Time frame: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in Patient skin pain assessment (VAS: 0-100)
Time frame: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
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 8 Nov 2022.
- Results for CAIN457AUS31 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 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 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 8 Nov 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?
Age (time frame: Baseline). The study lists 39 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 8 Nov 2022.