Psoriatic ArthritisNCT06172426
Incidence of Psoriatic Arthritis Among Psoriasis Patients Newly Initiated With Secukinumab in a US Claims Database and a UK Registry
An observational study of Psoriatic Arthritis and Psoriasis, run by Novartis Pharmaceuticals at 1 site in Switzerland.
Trial summary
This was a retrospective cohort study to assess the incidence rate of psoriatic arthritis (PsA) among psoriasis (PsO) patients newly initiated on secukinumab or any biologics/apremilast (small molecule). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis, Psoriasis
- How many people
- 1,171 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Nov 2022to 7 Dec 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
- Included patients with at least 1 secukinumab claim between 01 January 2015 and 30 June 2020 (index date is the first secukinumab claim)
- Included patients age ≥18 years as of the year of index date
- Included patients with at least 1 non-ruleout psoriasis diagnosis during 2 years of pre-index period
- Included patients with continuous medical/pharmacy coverage in the 2-year pre-index period
- Included patients with continuous medical/pharmacy coverage in the 1-year post-index period
- Included non-switched patients with secukinumab treatment on or after the enrollment between 01 January 2017 to 01 September 2020
Show all 12Show fewer
- Non-switched patients are those who did not use other biologics/apremilast treatments on the enrollment date
- Index date will be the date of the first secukinumab treatment date
- Included patients with age ≥ 18 on the index date
- Included patients with psoriasis diagnosis in the pre-index period and index date
- Included patients with ≥ 1 year follow-up period
- Follow-up period is the gap between patient's last visit date and index date
Who cannot join
- Excluded patients with any psoriatic arthritis diagnosis during 2 years to 5 years pre-index period, as well as on the index date
- Excluded patients with any biologics/apremilast including secukinumab claim during the 2-year pre-index (excluding index date)
- Excluded patients received other non-secukinumab biologics/apremilast during 6 months post index date period (including index date) (This criterion is only applicable for the secukinumab cohort)
- BADBIR cohort:
- Excluded patients with psoriatic arthritis (PsA) prior to and on index date
- Excluded patients with any biologics/apremilast including secukinumab in the baseline period
Trial locations and contacts
1 site in 1 country.
About this study
This was a retrospective cohort study to assess the incidence rate of psoriatic arthritis (PsA) among psoriasis (PsO) patients newly initiated on secukinumab or any biologics/apremilast (small molecule). The analysis was performed in two databases, IBM® MarketScan® database: Commercial Claims and Encounters (CCAE) and Medicare Supplemental Beneficiaries (MDCR) from 01 January 2010 to 30 June 2021 and BADBIR from 01 January 2016 to 01 September 2021.
- Conditions
- Psoriatic Arthritis, Psoriasis
- Medical subject headings
- Arthritis, Psoriatic, 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 |
|---|---|---|
| MarketScan® secukinumab, other biologics/apremilast, and any biologics/apremilast cohort | Not described | |
| BADBIR secukinumab cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposure-adjusted incidence rate of PsA per 100 patient-years among PsO patients who newly initiated secukinumab
Measured: Up to 11.5 years
Secondary outcomes (16)
Time from secukinumab initiation to the first PsA diagnosis
Measured: Up to 11.5 years
Age
Measured: Baseline
Gender
Measured: Baseline
Region
Measured: Baseline
Insurance type
Measured: Baseline
Ethnicity
Measured: Baseline
Weight
Measured: Baseline
Height
Measured: Baseline
Body mass index (BMI)
Measured: Baseline
Prior treatments
Measured: Baseline
Hard-to-treat locations
Measured: Baseline
Comorbidities
Measured: Baseline
Dermatology Life Quality Index (DLQI)
The DLQI is a validated, 10-question, self-reported questionnaire to evaluate the patient's perception of the impact of skin disease on quality of life. The DLQI is rated on a 4-point scale (0 = not at all to 3 = very much). The highest possible total score for the DLQI is 30, and higher scores indicate more severe impact on quality of life.
Measured: Baseline
Health Assessment Questionnaires - Disability Index (HAQ-DI)
The HAQ-DI is a 20-question scale assessing functional ability. The final HAQ-DI score ranges from 0 (no problems functioning) to 3 (not able to function).
Measured: Baseline
Psoriasis Area and Severity Index (PASI)
The Psoriasis Area and Severity Index (PASI) is the most widely used tool for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease).
Measured: Baseline
Body Surface Area (BSA)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start17 Nov 2022
- Primary completion7 Dec 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies 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
- 1,171 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
- NCT06172426
- Sponsor's protocol ID
- CAIN457A2026
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Psoriatic Arthritis Among Psoriasis Patients Newly Initiated With Secukinumab in a US Claims Database and a UK Registry
- ClinicalTrials.gov ID
- NCT06172426
- Acronym / sponsor ID
- CAIN457A2026
- Conditions
- Psoriatic Arthritis, Psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,171 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 15 Dec 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 was a retrospective cohort study to assess the incidence rate of psoriatic arthritis (PsA) among psoriasis (PsO) patients newly initiated on secukinumab or any biologics/apremilast (small molecule). The analysis was performed in two databases, IBM® MarketScan® database: Commercial Claims and Encounters (CCAE) and Medicare Supplemental Beneficiaries (MDCR) from 01 January 2010 to 30 June 2021 and BADBIR from 01 January 2016 to 01 September 2021.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MarketScan® secukinumab, other biologics/apremilast, and any biologics/apremilast cohort | – | – |
| BADBIR secukinumab cohort | – | – |
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 (12 listed)
- Included patients with at least 1 secukinumab claim between 01 January 2015 and 30 June 2020 (index date is the first secukinumab claim)
- Included patients age ≥18 years as of the year of index date
- Included patients with at least 1 non-ruleout psoriasis diagnosis during 2 years of pre-index period
- Included patients with continuous medical/pharmacy coverage in the 2-year pre-index period
- Included patients with continuous medical/pharmacy coverage in the 1-year post-index period
Key exclusion criteria (6 listed)
- Excluded patients with any psoriatic arthritis diagnosis during 2 years to 5 years pre-index period, as well as on the index date
- Excluded patients with any biologics/apremilast including secukinumab claim during the 2-year pre-index (excluding index date)
- Excluded patients received other non-secukinumab biologics/apremilast during 6 months post index date period (including index date) (This criterion is only applicable for the secukinumab cohort)
- Excluded patients with psoriatic arthritis (PsA) prior to and on index date
- Excluded patients with any biologics/apremilast including secukinumab in the baseline period
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
Exposure-adjusted incidence rate of PsA per 100 patient-years among PsO patients who newly initiated secukinumab
Time frame: Up to 11.5 years
16 secondary outcomes
Time from secukinumab initiation to the first PsA diagnosis
Time frame: Up to 11.5 years
Age
Time frame: Baseline
Gender
Time frame: Baseline
Region
Time frame: Baseline
Insurance type
Time frame: Baseline
Ethnicity
Time frame: Baseline
Weight
Time frame: Baseline
Height
Time frame: Baseline
Body mass index (BMI)
Time frame: Baseline
Prior treatments
Time frame: Baseline
Hard-to-treat locations
Time frame: Baseline
Comorbidities
Time frame: Baseline
Dermatology Life Quality Index (DLQI)
Time frame: Baseline
Health Assessment Questionnaires - Disability Index (HAQ-DI)
Time frame: Baseline
Psoriasis Area and Severity Index (PASI)
Time frame: Baseline
Body Surface Area (BSA)
Time frame: Baseline
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 15 Dec 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 Psoriatic Arthritis and Psoriasis, run by Novartis Pharmaceuticals at 1 site in Switzerland.
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 12 inclusion and 6 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 15 Dec 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 Switzerland. 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?
Exposure-adjusted incidence rate of PsA per 100 patient-years among PsO patients who newly initiated secukinumab (time frame: Up to 11.5 years). 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 15 Dec 2023.