A Study to Estimate Secukinumab Retention Rate in Psoriasis Patients With MASLD
Recruiting · NCT07683065 · Observational (researchers observe without assigning treatment) · Lead sponsor: Novartis Pharmaceuticals
View the official record on ClinicalTrials.gov →What this trial is about
This study aims to examine the retention rate of secukinumab in adult patients with plaque psoriasis (with or without psoriatic arthritis \[PsA\]) and metabolic dysfunction-associated steatotic liver disease (MASLD) in routine clinical practice in Spain, as well as hepatic biomarker trajectories. The study will use electronic medical record (EMR) data from multiple Spanish hospitals.
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Patients with a first recorded secukinumab prescription between 01 January 2021 and 31 December 2023.
- Patients aged ≥18 years at index date.
- Patients with no prior secukinumab exposure in available EMR history.
- Secukinumab must be patient's first-, second-, or third-line biologic therapy for psoriasis/psoriatic arthritis (PsA).
- Patients with documented administration per Summary of Product Characteristics dosing recommendations (SmPC).
- Patients with confirmed plaque psoriasis with or without PsA.
- Patients with at least one cardiometabolic risk factor.
- Patients with a confirmed MASLD diagnosis.
- Patients with baseline laboratory data available.
Exclusion criteria
- Patients with evidence of MASLD absence.
- Patients with malignant liver disease.
- Patients with a history of liver transplantation.
- Patients with alcohol use disorder.
- Patients with other chronic liver diseases.
- Patients with diseases or treatments which cause thrombocytopenia.
- Patients with decompensated cirrhosis.
- ther protocol-defined inclusion/exclusion criteria may apply.
Where it is running
4 locations listed.
- Novartis Investigative Site - Barcelona, Spain
- Novartis Investigative Site - Madrid, Spain
- Novartis Investigative Site - Málaga, Spain
- Novartis Investigative Site - Badalona, Barcelona, Spain