Status:
COMPLETED
Treatment Persistence of Biologics in Patients with PsA in Japan; Retrospective Cohort Study Using a Claims Database
Lead Sponsor:
Novartis
Conditions:
Psoriatic Arthritis
Eligibility:
All Genders
18+ years
Brief 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 i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 17 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 15 2023
Estimated Enrollment :
534 Patients enrolled
Trial Details
Trial ID
NCT06600009
Start Date
October 17 2022
End Date
September 15 2023
Last Update
September 19 2024
Active Locations (1)
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1
Novartis Pharma K.K.
Tokyo, Japan, 105-6333