Plaque PsoriasisNCT05368818
An Analysis of the Improvement and Quality of Life Trends for UK/ROI Patients Treated With Cosentyx (Secukinumab) in a Retrospective Analysis of the BADBIR Data Source
An observational study of Plaque Psoriasis, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This was a retrospective, observational study of psoriasis patients treated with secukinumab, using secondary data from BADBIR. BADBIR is a UK/ROI pharmacovigilance registry that was initiated in 2007 to monitor the long-term safety of biologic drugs used to treat psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Secukinumab
- How many people
- 767 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2020to 6 May 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The BADBIR registry included patients treated for psoriasis using biologics, conventional systemic therapies, or small molecule immunomodulators
Who may be able to join
- Age ≥18 years at initiation of secukinumab.
- At least one follow-up visit post-registry enrollment.
- On-label dosing of secukinumab of 300mg.
- Age ≥18 years at initiation of secukinumab.
- At least one follow-up visit post-registry enrollment.
- On-label dosing of secukinumab of 300mg.
- Diagnosis of PsA at baseline.
Who cannot join
- The patient did not meet the criteria stated above.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
East Hanover, New Jersey, 07936-1080
About this study
This was a retrospective, observational study of psoriasis patients treated with secukinumab, using secondary data from BADBIR. BADBIR is a UK/ROI pharmacovigilance registry that was initiated in 2007 to monitor the long-term safety of biologic drugs used to treat psoriasis. The study used longitudinal data within the registry to track the trends relating to the disease. For the analysis of improvement and patient reported QoL, patients with a minimum of one follow-up visit were included. The index date was defined as the date of initiation of secukinumab treatment, and follow-up visits were at 6-, 12-, 18-, \& 24-months post-index.
Read the detailed description
The BADBIR data was current up until the 31st August 2019 for this analysis.
Study period: From 1st July 2015, as secukinumab was included in BADBIR in January 2016 and patients backdated 6 months, to 31st August 2019.
Identification period: From 1st July 2015 to 31st August 2019 was used to identify applicable patients for analysis.
Index date: Initiation of secukinumab treatment within the BADBIR database.
- Conditions
- Plaque Psoriasis
- Being tested
- Secukinumab
- Keywords
- Cosentyx,, Secukinumab,, Quality of Life,, UK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabOther
Also called Cosentyx
Included patients treated with Cosentyx (Secukinumab) in a retrospective analysis of the BADBIR data source
| Study group | Role | What they receive |
|---|---|---|
| All patients | Included all patients prescribed an on-label secukinumab dose Receives: Other: Secukinumab | |
| Patients with Psoriatic Arthritis (PsA) | Included patients classified as having a concomitant PsA diagnosis, if it was declared in the Baseline table Receives: Other: Secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients reporting high/very high QoL changes from Baseline (BL) (from 2 or 3 at BL to 0)
Patient reported QoL for five specific DLQI domains from baseline up to 24 months of UK/ROI psoriasis patients enrolled in BADBIR who were initiated on secukinumab treatment were reported.
Following 5 domains were included:
- Embarrassment and/or self conciousness
- Social leisure
- Work/study
- Problems relating to partner, friends and relatives
- Sexual difficulties
Measured: throughout the study, approximately 4 years (1st July 2015 to 31st August 2019 )
Secondary outcomes (27)
Age
Age was reported
Measured: Baseline
Sex
Sex information was reported
Measured: Baseline
Ethinicity
Ethinicity information was reported
Measured: Baseline
Employment status
Employment status was reported
Measured: Baseline
Smoking Characteristics
Smoking characteristics were reported
Measured: Baseline
Weight
Weight information was reported
Measured: Baseline
Height
Height information was reported
Measured: Baseline
Body Mass Index (BMI)
BMI information was reported
Measured: Baseline
Waist circumference
Waist information was reported
Measured: Baseline
Absolute Psoriasis Area Severity Index (aPASI) at BL
aPASI scores were reported
Measured: Baseline
Total Dermatology Life Quality Index (DLQI) at BL
Total DLQI score was reported
Measured: Baseline
DQLI Domain - 2) embarrassment and/or self-consciousness - proportion of those who reported high or very high at baseline
DQLI Domain - 2) embarrassment and/or self-consciousness - proportion of those who reported high or very high at baseline were reported
Measured: Baseline
DQLI Domain - 5) social and leisure activities - proportion of those who reported high or very high at baseline
DQLI Domain - 5) social and leisure activities - proportion of those who reported high or very high at baseline were reported
Measured: Baseline
DQLI Domain - 7) work/study - proportion of those who reported high or very high at baseline
DQLI Domain - 7) work/study - proportion of those who reported high or very high at baseline were reported
Measured: Baseline
DQLI Domain - 8) problems relating to partner, friends, and relatives - proportion of those who reported high or very high at baseline
DQLI Domain - 8) problems relating to partner, friends, and relatives - proportion of those who reported high or very high at baseline were reported
Measured: Baseline
DQLI Domain - 9) sexual difficulties - proportion of those who reported high or very high at baseline
DQLI Domain - 9) sexual difficulties - proportion of those who reported high or very high at baseline were reported
Measured: Baseline
Number of Biologic naïve/experienced patients
Patients were listed as being previously experienced to a biologic treatment if a drug name listed in 'Biologics_Drugname', was listed as a 'DrugName' in the DrugPastTherapy table. If a patient had no record of a biologic drugname in the DrugPastTherapy table, the patient was recorded as biologic naive.
Measured: Baseline
Number of Psoriatic Arthritis (PsA) patients
Patients were classified as Psoriatic Arthritis using the 'PsoriaticArthritis' flag in the Baseline_Psoriasis tables. (0=No, 1=Yes, Null=not entered).
Measured: Baseline
Time to PsA diagnosis
Time to PsA onset was calculated using the 'PsoriaticArthritisOnset' variable from the FupPsoriasis table and 'YearOnset' from the Baseline Psoriasis table. The time to PsA diagnosis was reported as the difference between 'PsoriaticArthritisOnset' minus 'YearOnset'.
Measured: Baseline
Number of patients with No PsA and nail involvement
Patients were classified as having nail involvement using the 'NailsNumber' variable from the Baseline_Psoriasis table
Measured: Baseline
Number of nails involved
Number of nails involved were reported
Measured: Baseline
Number of patients with at least one Comorbidity
Comorbidities were derived from the MedDRA Preferred Term (PT) variable in the BaselineComorbidities table. If a patient recorded at least one comorbidity, listed within the available data, this patient was recorded as "Has a comorbidity".
Measured: Baseline
Number of patients with five most common comorbidities at BL
Comorbidities were derived from the MedDRA Preferred Term (PT) variable in the BaselineComorbidities table. If a patient recorded at least one comorbidity, listed within the available data, this patient was recorded as "Has a comorbidity". The top 5 comorbidities at baseline were determined via highest frequency of occurrence by cohort and were reported for each subgroup
Measured: Baseline
Frequency of on-label 300mg prescription
Frequency of on-label 300mg prescription was categorized into the following, N/A (new convention for licensed dose), Once a week (induction), Once monthly \& Once every four weeks. To determine if the patients were on-label, confirmation was required that the right dosage was being given; patients were included as on-label if they reported a dose value of 300 using the 'Dose' and the unit mg with the 'DoseUnit' variable in the DrugBiologicTherapy table. The frequency of prescription was assessed using the 'Frequency' variable and mapped in accordance with the following categories: N/A (new convention for licensed dose), Once a week (induction), Once monthly, once every four weeks or Not reported.
Measured: Baseline
Proportion of PsA subjects with a total DLQI score of >10
Proportion of PsA subjects with a total DLQI score of >10 at baseline achieving a score of 0 or 1 at 6-month intervals to 24 months (window of +/- 60 days), stratified by none, any, <5 nails, ≥5 nails or all nails involved at baseline was reported.
Measured: throughout the study, approximately 4 years (1st July 2015 to 31st August 2019)
Proportion of PsA patients with an aPASI score of 0, <=1, <=2 or <=3
Proportion of PsA patients with an aPASI score of 0, <=1, <=2 or <=3 at each 6-month interval up to 24 months (window of +/-60 days), stratified by none, any, <5 nails, ≥5 nails or all nails involved at baseline was reported.
Measured: throughout the study, approximately 4 years (1st July 2015 to 31st August 2019)
Proportion of Psoriasis patients with an aPASI score of 0, <=1, <=2 or <=3
Proportion of Psoriasis patients with an aPASI score of 0, <=1, <=2 or <=3 at each 6-month interval up to 24 months (window of +/-60 days), stratified by patients being biologic naive or biologic experienced was reported.
Measured: throughout the study, approximately 4 years (1st July 2015 to 31st August 2019)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start7 Dec 2020
- Primary completion6 May 2021
- Study completion6 May 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
- 767 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
- NCT05368818
- Sponsor's protocol ID
- CAIN457AGB06
- Status last verified
- Jun 2022
- First submitted
- 5 May 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
- An Analysis of the Improvement and Quality of Life Trends for UK/ROI Patients Treated With Cosentyx (Secukinumab) in a Retrospective Analysis of the BADBIR Data Source
- ClinicalTrials.gov ID
- NCT05368818
- Acronym / sponsor ID
- CAIN457AGB06
- Conditions
- Plaque Psoriasis
- Keywords
- Cosentyx,, Secukinumab,, Quality of Life,, UK
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 767 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 6 May 2021 (actual)
- Study completion
- 6 May 2021 (actual)
- First posted
- 10 May 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 was a retrospective, observational study of psoriasis patients treated with secukinumab, using secondary data from BADBIR. BADBIR is a UK/ROI pharmacovigilance registry that was initiated in 2007 to monitor the long-term safety of biologic drugs used to treat psoriasis. The study used longitudinal data within the registry to track the trends relating to the disease. For the analysis of improvement and patient reported QoL, patients with a minimum of one follow-up visit were included. The index date was defined as the date of initiation of secukinumab treatment, and follow-up visits were at 6-, 12-, 18-, \& 24-months post-index.
Detailed description
The BADBIR data was current up until the 31st August 2019 for this analysis.
Study period: From 1st July 2015, as secukinumab was included in BADBIR in January 2016 and patients backdated 6 months, to 31st August 2019.
Identification period: From 1st July 2015 to 31st August 2019 was used to identify applicable patients for analysis.
Index date: Initiation of secukinumab treatment within the BADBIR database.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Other: SecukinumabIncluded all patients prescribed an on-label secukinumab dose |
| Patients with Psoriatic Arthritis (PsA) | – | Other: SecukinumabIncluded patients classified as having a concomitant PsA diagnosis, if it was declared in the Baseline table |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The BADBIR registry included patients treated for psoriasis using biologics, conventional systemic therapies, or small molecule immunomodulators
Key inclusion criteria (7 listed)
- Age ≥18 years at initiation of secukinumab.
- At least one follow-up visit post-registry enrollment.
- On-label dosing of secukinumab of 300mg.
- Age ≥18 years at initiation of secukinumab.
- At least one follow-up visit post-registry enrollment.
Key exclusion criteria (1 listed)
- The patient did not meet the criteria stated above.
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 patients treated with Cosentyx (Secukinumab) in a retrospective analysis of the BADBIR data source | Other | All patients, Patients with Psoriatic Arthritis (PsA) |
Primary outcome
Proportion of patients reporting high/very high QoL changes from Baseline (BL) (from 2 or 3 at BL to 0)
Time frame: throughout the study, approximately 4 years (1st July 2015 to 31st August 2019 )
Patient reported QoL for five specific DLQI domains from baseline up to 24 months of UK/ROI psoriasis patients enrolled in BADBIR who were initiated on secukinumab treatment were reported. Following 5 domains were included: * Embarrassment and/or self conciousness * Social leisure * Work/study * Problems relating to partner, friends and relatives * Sexual difficulties
27 secondary outcomes
Age
Time frame: Baseline
Sex
Time frame: Baseline
Ethinicity
Time frame: Baseline
Employment status
Time frame: Baseline
Smoking Characteristics
Time frame: Baseline
Weight
Time frame: Baseline
Height
Time frame: Baseline
Body Mass Index (BMI)
Time frame: Baseline
Waist circumference
Time frame: Baseline
Absolute Psoriasis Area Severity Index (aPASI) at BL
Time frame: Baseline
Total Dermatology Life Quality Index (DLQI) at BL
Time frame: Baseline
DQLI Domain - 2) embarrassment and/or self-consciousness - proportion of those who reported high or very high at baseline
Time frame: Baseline
DQLI Domain - 5) social and leisure activities - proportion of those who reported high or very high at baseline
Time frame: Baseline
DQLI Domain - 7) work/study - proportion of those who reported high or very high at baseline
Time frame: Baseline
DQLI Domain - 8) problems relating to partner, friends, and relatives - proportion of those who reported high or very high at baseline
Time frame: Baseline
DQLI Domain - 9) sexual difficulties - proportion of those who reported high or very high at baseline
Time frame: Baseline
Number of Biologic naïve/experienced patients
Time frame: Baseline
Number of Psoriatic Arthritis (PsA) patients
Time frame: Baseline
Time to PsA diagnosis
Time frame: Baseline
Number of patients with No PsA and nail involvement
Time frame: Baseline
Number of nails involved
Time frame: Baseline
Number of patients with at least one Comorbidity
Time frame: Baseline
Number of patients with five most common comorbidities at BL
Time frame: Baseline
Frequency of on-label 300mg prescription
Time frame: Baseline
Proportion of PsA subjects with a total DLQI score of >10
Time frame: throughout the study, approximately 4 years (1st July 2015 to 31st August 2019)
Proportion of PsA patients with an aPASI score of 0, <=1, <=2 or <=3
Time frame: throughout the study, approximately 4 years (1st July 2015 to 31st August 2019)
Proportion of Psoriasis patients with an aPASI score of 0, <=1, <=2 or <=3
Time frame: throughout the study, approximately 4 years (1st July 2015 to 31st August 2019)
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 CAIN457AGB06 from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
Related trials for Plaque Psoriasis
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
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 7 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 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?
Proportion of patients reporting high/very high QoL changes from Baseline (BL) (from 2 or 3 at BL to 0) (time frame: throughout the study, approximately 4 years (1st July 2015 to 31st August 2019 )). 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.