PsoriasisNCT05320159

Treatment Effectiveness Among Psoriasis Patients Treated With Cosentyx (Secukinumab)

An observational study of Psoriasis, run by Novartis Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Psoriasis
What is being tested?: Secukinumab
Type of treatment: Pill or oral medicine, Injection or infusion
How many people: 17,743 participants
Where: 1 siteUnited States
Study dates: 3 Feb 2021to 31 Mar 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: Psoriasis patients treated with Cosentyx (secukinumab)

Who may be able to join

≥1 orders/administrations for secukinumab within the index window (March 1, 2018 to August 31,2019 for the base analysis; March 1, 2018 to January 31, 2020 for the refresh analysis). The date of the first order or administration was be the index date
Patients in the MMDS database with a diagnosis of PsO on or prior to the 1st secukinumab order/administration
≥18 years of age as of the index date
To ensure capturing continuous patient activities in the EMR dataset, patients must have at least one more visit (any visit regardless of diagnosis) in addition to the index visit within the first 6 months after secukinumab initiation
Patients must have at least one visit (any visit regardless of diagnosis) within the 12 months pre-index period

Who cannot join

Evidence of secukinumab use in the 12-month pre-index period
Data quality issues (missing age, gender, prescription order information)

Trial locations and contacts

1 site in 1 country.

United States1 site

Novartis Investigative Site
East Hanover, New Jersey, 07936-1080

Other trials in United States

About this study

Official title: Characteristics, Treatment Patterns, and Treatment Satisfaction Among Psoriasis Patients Treated With Cosentyx (Secukinumab)

Read the detailed description

This was a retrospective cohort study utilizing data from Modernizing Medicine Data Services' (MMDS) electronic medical records (EMR)-based dermatology database to evaluate secukinumab patient characteristics, treatment patterns, and outcomes. Psoriasis (PsO) patients initiating secukinumab were identified and indexed to the first secukinumab use using the most recent data at study initiation (data period: March 1, 2018 to August 31, 2019) and with a subsequent data refresh (data period: March 1, 2017 - July 31, 2020).

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
Also called Cosentyx
Included all the patients treated with secukinumab

Study groups in NCT05320159
Study group	Role	What they receive
Overall cohort: Secukinumab		Included all the patients treated with secukinumab Receives: Drug: Secukinumab
Bio-naive		Included PsO patients initiating treatment with secukinumab. Bio-naïve was defined as no observed treatment (i.e., injection, prescription or patient reported history) with any of the following biologic drugs of interest anytime pre-index: secukinumab, certolizumab, etanercept, adalimumab, infliximab, golimumab, ustekinumab, ixekizumab, brodalumab, abatacept, and guselkumab and risankizumab during all available history Receives: Drug: Secukinumab
Bio-experienced		Included PsO patients initiating treatment with secukinumab. Patients had pre-index use of one or more of the biologic drugs of interest during all available history Receives: Drug: Secukinumab
Systemic-naive		Included PsO patients initiating treatment with secukinumab. Systemic-naïve was defined as no observed treatment (i.e., injection, prescription or patient reported history) with any of the biologic treatments or with any of the following systemic (i.e., oral or injectable - no topical forms) drugs of interest pre-index: methotrexate, corticosteroids, acitretin or apremilast. Receives: Drug: Secukinumab
Systemic-experienced		Included PsO patients initiating treatment with secukinumab. Systemic-experienced patients had pre-index use of one or more of the systemic drugs of interest. Receives: Drug: Secukinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment satisfaction level at Baseline
Patient reported satisfaction with treatment effectiveness was captured on a 5-point scale - "I believe this treatment is effective in clearing my skin of psoriasis." (1 = strongly agree, 2 = somewhat agree, 3 = Neither agree nor disagree, 4 = Somewhat disagree, 5 = Strongly disagree; n, %) in the EMR data system.
For this analysis, the responses were classified into three groups:
1. Satisfied with treatment effectiveness (1 = strongly agree, 2 = somewhat agree)
2. Dissatisfied with treatment effectiveness ( 4 = Somewhat disagree, 5 = Strongly disagree)
3. Neither satisfied nor dissatisfied with treatment effectiveness (3 = Neither agree nor disagree)
Measured: Baseline
Treatment satisfaction level at 6 months post-index
Patient reported satisfaction with treatment effectiveness was captured on a 5-point scale - "I believe this treatment is effective in clearing my skin of psoriasis." (1 = strongly agree, 2 = somewhat agree, 3 = Neither agree nor disagree, 4 = Somewhat disagree, 5 = Strongly disagree; n, %) in the EMR data system.
For this analysis, the responses were classified into three groups:
1. Satisfied with treatment effectiveness (1 = strongly agree, 2 = somewhat agree)
2. Dissatisfied with treatment effectiveness ( 4 = Somewhat disagree, 5 = Strongly disagree)
3. Neither satisfied nor dissatisfied with treatment effectiveness (3 = Neither agree nor disagree)
Measured: 6 months after initiating treatment with secukinumab (The date of the first order or administration was the index date; index period: March 1, 2018 - January 31, 2020)

Secondary outcomes (12)

Age
Age information was reported
Measured: Baseline (March 1, 2017 - March 1, 2018)
Gender
Gender information was reported
Measured: Baseline (March 1, 2017 - March 1, 2018)
Number of patients at various regions
Patient regions: Northeast, Midwest, South, West, Unknown
Measured: Baseline (March 1, 2017 - March 1, 2018)
Number of patients with different race
Race: White, Hispanic, African American, Asian, other/unknown
Measured: Baseline (March 1, 2017 - March 1, 2018)
Weight
Weight of patients was reported
Measured: Baseline (March 1, 2017 - March 1, 2018)
Number of patients at Index year
Number of patients at each index year were reported
Measured: Study Period: March 1, 2017 - July 31, 2020
Number of patients with plaque psoriasis subtype
Plaque psoriasis subtype was categorized as: generalized plaque psoriasis, localized plaque psoriasis, localized scalp psoriasis, inverse psoriasis, palmoplantar psoriasis, guttate psoriasis, nail psoriasis, psoriasis vulgaris, ostraceous psoriasis, or plaque psoriasis with unknown subtype during the 12 month pre-index period (including index date)
Measured: Baseline (March 1, 2017 - March 1, 2018)
Number of patients with Plaque location
Plaque location was categorized as recorded in EMR, including hand, arm, leg, trunk, scalp, head and neck, other/unknown
Measured: Baseline (March 1, 2017 - March 1, 2018)
Comorbidities of interest
Comorbidities of interest during the 12 months pre-index were reported
Measured: Baseline (March 1, 2017 - March 1, 2018)
Physician global assessment (PGA)
PGA is scored on a 6-point scale from 0-5: 0 = clear, 1 = minimal, 2 = mild, 3 =moderate, 4 = marked, and 5 = severe
Measured: Baseline and 6 months post index including index date (The date of the first order or administration was the index date; index period: March 1, 2018 - January 31, 2020)
Total body surface area (TBSA)
Total body surface area (BSA) was expressed as the percentage of body surface involved; BSA values of <3%, 3-10%, and >10% (reported as n, %) will be considered as mild, moderate, or severe, respectively.
Measured: Baseline and 6 months post index including index date (The date of the first order or administration was the index date; index period: March 1, 2018 - January 31, 2020)
Psoriasis-related therapy
The following categories were included:
1. Biologics
2. Methotrexate
3. Corticosteroids (oral/injection)
4. Topical therapy
5. Phototherapy and Psoralen plus ultraviolet A photochemotherapy (PUVA)
6. NSAID/salicylates
7. Other systemic plaque psoriasis therapy (Acitretin)
8. Apremilast (PDE4 inhibitor)
Measured: 6 months post index including index date (The date of the first order or administration was the index date; index period: March 1, 2018 - January 31, 2020)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Feb 202131 Mar 2021

First posted11 Apr 2022
Study start3 Feb 2021
Primary completion31 Mar 2021
Study completion31 Mar 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: 17,743 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05320159
Sponsor's protocol ID: CAIN457AUS28
Status last verified: Jun 2022
First submitted: 30 Mar 2022
Last updated: 1 Jul 2022
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
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All Psoriasis trials

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: Characteristics, Treatment Patterns, and Treatment Satisfaction Among Psoriasis Patients Treated With Cosentyx (Secukinumab)
ClinicalTrials.gov ID: NCT05320159
Acronym / sponsor ID: CAIN457AUS28
Conditions: Psoriasis
Study type: Observational
Recruitment status: Completed
Enrolment: 17,743 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 3 Feb 2021 (actual)
Primary completion: 31 Mar 2021 (actual)
Study completion: 31 Mar 2021 (actual)
First posted: 11 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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 5

Arm	Type	Receives
Overall cohort: Secukinumab	–	Drug: SecukinumabIncluded all the patients treated with secukinumab
Bio-naive	–	Drug: SecukinumabIncluded PsO patients initiating treatment with secukinumab. Bio-naïve was defined as no observed treatment (i.e., injection, prescription or patient reported history) with any of the following biologic drugs of interest anytime pre-index: secukinumab, certolizumab, etanercept, adalimumab, infliximab, golimumab, ustekinumab, ixekizumab, brodalumab, abatacept, and guselkumab and risankizumab during all available history
Bio-experienced	–	Drug: SecukinumabIncluded PsO patients initiating treatment with secukinumab. Patients had pre-index use of one or more of the biologic drugs of interest during all available history
Systemic-naive	–	Drug: SecukinumabIncluded PsO patients initiating treatment with secukinumab. Systemic-naïve was defined as no observed treatment (i.e., injection, prescription or patient reported history) with any of the biologic treatments or with any of the following systemic (i.e., oral or injectable - no topical forms) drugs of interest pre-index: methotrexate, corticosteroids, acitretin or apremilast.
Systemic-experienced	–	Drug: SecukinumabIncluded PsO patients initiating treatment with secukinumab. Systemic-experienced patients had pre-index use of one or more of the systemic drugs of interest.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Psoriasis patients treated with Cosentyx (secukinumab)

Key inclusion criteria (5 listed)

≥1 orders/administrations for secukinumab within the index window (March 1, 2018 to August 31,2019 for the base analysis; March 1, 2018 to January 31, 2020 for the refresh analysis). The date of the first order or administration was be the index date
Patients in the MMDS database with a diagnosis of PsO on or prior to the 1st secukinumab order/administration
≥18 years of age as of the index date
To ensure capturing continuous patient activities in the EMR dataset, patients must have at least one more visit (any visit regardless of diagnosis) in addition to the index visit within the first 6 months after secukinumab initiation
Patients must have at least one visit (any visit regardless of diagnosis) within the 12 months pre-index period

Key exclusion criteria (2 listed)

Evidence of secukinumab use in the 12-month pre-index period
Data quality issues (missing age, gender, prescription order information)

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
SecukinumabAlso: CosentyxIncluded all the patients treated with secukinumab	Drug	Bio-experienced, Bio-naive, Overall cohort: Secukinumab, Systemic-experienced, Systemic-naive

Primary outcome

Treatment satisfaction level at Baseline
Time frame: Baseline
Patient reported satisfaction with treatment effectiveness was captured on a 5-point scale - "I believe this treatment is effective in clearing my skin of psoriasis." (1 = strongly agree, 2 = somewhat agree, 3 = Neither agree nor disagree, 4 = Somewhat disagree, 5 = Strongly disagree; n, %) in the EMR data system. For this analysis, the responses were classified into three groups: 1. Satisfied with treatment effectiveness (1 = strongly agree, 2 = somewhat agree) 2. Dissatisfied with treatment effectiveness ( 4 = Somewhat disagree, 5 = Strongly disagree) 3. Neither satisfied nor dissatisfied with treatment effectiveness (3 = Neither agree nor disagree)
Treatment satisfaction level at 6 months post-index
Time frame: 6 months after initiating treatment with secukinumab (The date of the first order or administration was the index date; index period: March 1, 2018 - January 31, 2020)
Patient reported satisfaction with treatment effectiveness was captured on a 5-point scale - "I believe this treatment is effective in clearing my skin of psoriasis." (1 = strongly agree, 2 = somewhat agree, 3 = Neither agree nor disagree, 4 = Somewhat disagree, 5 = Strongly disagree; n, %) in the EMR data system. For this analysis, the responses were classified into three groups: 1. Satisfied with treatment effectiveness (1 = strongly agree, 2 = somewhat agree) 2. Dissatisfied with treatment effectiveness ( 4 = Somewhat disagree, 5 = Strongly disagree) 3. Neither satisfied nor dissatisfied with treatment effectiveness (3 = Neither agree nor disagree)

12 secondary outcomes

Age
Time frame: Baseline (March 1, 2017 - March 1, 2018)
Gender
Time frame: Baseline (March 1, 2017 - March 1, 2018)
Number of patients at various regions
Time frame: Baseline (March 1, 2017 - March 1, 2018)
Number of patients with different race
Time frame: Baseline (March 1, 2017 - March 1, 2018)
Weight
Time frame: Baseline (March 1, 2017 - March 1, 2018)
Number of patients at Index year
Time frame: Study Period: March 1, 2017 - July 31, 2020
Number of patients with plaque psoriasis subtype
Time frame: Baseline (March 1, 2017 - March 1, 2018)
Number of patients with Plaque location
Time frame: Baseline (March 1, 2017 - March 1, 2018)
Comorbidities of interest
Time frame: Baseline (March 1, 2017 - March 1, 2018)
Physician global assessment (PGA)
Time frame: Baseline and 6 months post index including index date (The date of the first order or administration was the index date; index period: March 1, 2018 - January 31, 2020)
Total body surface area (TBSA)
Time frame: Baseline and 6 months post index including index date (The date of the first order or administration was the index date; index period: March 1, 2018 - January 31, 2020)
Psoriasis-related therapy
Time frame: 6 months post index including index date (The date of the first order or administration was the index date; index period: March 1, 2018 - January 31, 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 1 Jul 2022.
Results for CAIN457AUS28 from the Novartis Clinical Trials Results DatabaseLink provided by the sponsor.

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
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Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
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RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

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 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?

Treatment satisfaction level at Baseline (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05320159.

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.