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Completed

NCT Number: NCT06600009

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

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.

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Key information

Conditions

Psoriatic Arthritis Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Pharma K.K.

Tokyo, 105-6333, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

secukinumab

Drug

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

Adalimumab

Drug

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

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Acronym: FLYWAY

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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