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CompletedNCT06600009FLYWAYUpdated Sep 19, 2024

Treatment Persistence of Biologics in Patients with PsA in Japan; Retrospective Cohort Study Using a Claims Database

An observational study in Psoriatic Arthritis, sponsored by Novartis. Completed at 1 site in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Novartis · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
534
Ages
18 Years and older
Sex
All
01

Study summary

This study was a retrospective non-interventional cohort study with secondary use of data from the Medical Data Vision (MDV) hospital-based database. The study setting was defined as follows:

  • The inclusion period covered 01 February 2015 to 30 September 2020.
  • The study period covered 01 August 2014 to 30 September 2021 inclusive.
  • The index date was defined as the date of the first prescription of secukinumab or adalimumab within the inclusion period.
  • The pre-index period was defined as the 6-month period before the index date (exclusive).
  • Patients were followed until death, discontinuation of treatments of interest or end of the study period, whichever occurred first.
02

Conditions studied

  • Psoriatic Arthritis

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Keywords

  • PSA
03

In context

Arthritis, Psoriatic

594 studies on the registry are indexed under Arthritis, Psoriatic; 132 are open to participants now.

This study's enrollment of 534 is above the median of 300 across 243 observational studies indexed under Arthritis, Psoriatic.

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Lead sponsor

Novartis is the lead sponsor of 714 studies on the registry; none are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This was a retrospective, noninterventional cohort study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Having at least one biologic agent prescription of interest (secukinumab or adalimumab - princeps or biosimilars) recorded, in accordance with package insert, during the inclusion period (first prescription: index date).
  • Having a confirmed diagnosis of PsA (the international classification of diseases, 10th revision [ICD-10]: L405) (at least 1 inpatient or outpatient claim without any doubtful flag) recorded during the pre-index period or at the index date.
  • Being age 18 years or older at the index date.
  • Having at least a 6-month pre-index period.

Bio-naive subgroup:

  • Patients were considered as bio-naive if no record of any biologic agent prescriptions indicated for psoriasis or PsA (infliximab, adalimumab, certolizumab pegol, ustekinumab, risankizumab, guselkumab, secukinumab, ixekizumab, brodalumab - princeps or biosimilars) were retrieved during the pre-index period.

Exclusion criteria

Exclusion Criteria:

  • Having a biologic agent overdose (over 300 mg for secukinumab and over 80 mg for adalimumab) observed during the study period (off-label),
  • Having at least one record of secukinumab (for secukinumab patients) or adalimumab (for adalimumab patients) retrieved during the pre-index period.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
534 participants (actual)
Patient registry
No

Groups and cohorts

  • Secukinumab

    Patients had received secukinumab treatment.

    Drug: Secukinumab

  • Adalimumab

    Patients had received adalimumab treatment.

    Drug: Adalimumab

Interventions

  • DrugSecukinumab

    Patients had received secukinumab per their dosing regimens prior to this observational study.

  • DrugAdalimumab

    Patients had received adalimumab per their dosing regimens prior to this observational study.

06

What researchers measure

Primary outcomes

  1. Number of Patients with Persistence of Secukinumab Treatment at One Year

    Time frame: 1 year

Secondary outcomes

  1. Sex

    Time frame: Baseline

  2. Age

    Time frame: Baseline

  3. Number of Patients, Categorized by Medical Facility Department

    Time frame: Baseline

  4. Height

    Time frame: Baseline

  5. Weight

    Time frame: Baseline

  6. Body Mass Index (BMI)

    Time frame: Baseline

  7. Time from PsA Diagnosis to Index Date, Categorized by Medical Facility Department

    Time frame: Up approximately 6 months

  8. Number of Patients with Comorbidities, by Category

    Time frame: Baseline

  9. Number of Patients on Concomitant Treatments

    Time frame: Baseline

  10. C-reactive Protein (CRP)

    Time frame: Baseline

  11. Change in C-reactive Protein (CRP) Since Administration of Secukinumab or Adalimumab in Patients Still Treated with the Drug at the End of Follow-up

    Time frame: Up to approximately 5 years

  12. Change in C-reactive Protein (CRP) Since Administration of Secukinumab or Adalimumab in Patients Who Discontinued the Drug

    Time frame: Up to approximately 5 years

  13. Time from Index Date to the Start of Methotrexate Add-on

    Time frame: Up to approximately 5 years

  14. Time from Index Date to Methotrexate Discontinuation in Methotrexate Naive Patients at Index Date

    Time frame: Up to approximately 5 years

  15. Time from Index Date to Methotrexate Discontinuation in Methotrexate Experienced Patients at Index Date

    Time frame: Up to approximately 5 years

  16. Secukinumab/adalimumab Dose at the Start of Methotrexate Add-on

    Time frame: Up to approximately 5 years

  17. Secukinumab/adalimumab Dose at Methotrexate Discontinuation

    Time frame: Up to approximately 5 years

  18. Number of Patients with Methotrexate Add-on During Follow-up

    Time frame: Up to approximately 5 years

  19. Average Secukinumab/adalimumab Dose at Index Date

    Time frame: Baseline

  20. Number of Patients with Persistence of Secukinumab or Adalimumab Treatment

    Time frame: 24 weeks, 1 year, 1.5 years, 2 years, 2.5 years, and 3 years

  21. Time from PsA Diagnosis to Index Date for Adalimumab Patients

    Time frame: Up approximately 6 months

  22. Number of Adalimumab Patients, Categorized by Medical Facility

    Time frame: Baseline

  23. Number of Patients with Presence or Absence of Methotrexate

    Time frame: Baseline

07

Study locations

1 site
  • Novartis Pharma K.K.
    Tokyo, 105-6333, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06600009
Lead sponsor
Novartis
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Oct 17, 2022
Primary completion
Aug 21, 2023
Completion
Sep 15, 2023
Last update
Sep 19, 2024

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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