Incidence of Psoriatic Arthritis Among Psoriasis Patients... | NCT06172426

Studies
Incidence of Psoriatic Arthritis Among Psoriasis Patients Newly Initiated With Secukinumab in a US Claims Database and a UK Registry

NCT06172426

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Dec 15, 2023Actual

Enrollment

1,171Actual

Phase

Not provided

Conditions

Psoriatic Arthritis
Psoriasis

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 17, 2022Actual

Primary Completion Date

Dec 7, 2022Actual

Completion Date

Dec 7, 2022Actual

First Submitted Date

Dec 7, 2023

First Submission Date that Met QC Criteria

Dec 7, 2023

First Posted Date

Dec 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2023

Last Update Posted Date

Dec 15, 2023Actual

Description Module

Brief 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). 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,171Actual

Measure	Description	Time Frame
Exposure-adjusted incidence rate of PsA per 100 patient-years among PsO patients who newly initiated secukinumab		Up to 11.5 years

Measure	Description	Time Frame
Time from secukinumab initiation to the first PsA diagnosis		Up to 11.5 years
Age		Baseline
Gender

Eligibility Module

Eligibility Criteria

MarketScan® secukinumab cohort:

Inclusion criteria:

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

Exclusion criteria:

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:

Inclusion criteria:

Included non-switched patients with secukinumab treatment on or after the enrollment between 01 January 2017 to 01 September 2020
- 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

Exclusion criteria:

Excluded patients with psoriatic arthritis (PsA) prior to and on index date
Excluded patients with any biologics/apremilast including secukinumab in the baseline period

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

This was a retrospective, noninterventional cohort study.

Sampling Method

Non-Probability Sample

Label	Type	Description	Intervention Names
MarketScan® secukinumab, other biologics/apremilast, and any biologics/apremilast cohort
BADBIR secukinumab cohort

ID	Term
D015535	Arthritis, Psoriatic
D011565	Psoriasis

ID	Term
D025242	Spondylarthropathies
D025241	Spondylarthritis
D013166	Spondylitis
D013122	Spinal Diseases