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Recruiting NCT07683065

A Study to Estimate Secukinumab Retention Rate in Psoriasis Patients With MASLD

— Observational Plaque Psoriasis Metabolic Dysfunction-Associated Steatotic Liver Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Plaque Psoriasis, Metabolic Dysfunction-Associated Steatotic Liver Disease. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

SEC-HOPE: A Multicenter Retrospective Cohort Study to Estimate Secukinumab Retention Rate in Psoriasis Patients With MASLD

Overview

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.

Primary outcome measures

  • Number of Definitive Discontinuation Events Per Patient-Year [Time frame: Up to 5 years]
Secondary outcome measures (12)
  • Cumulative Incidence of Treatment Discontinuation Due to Lack of Response [Time frame: Up to 5 years]
  • Proportion of Patients who Achieve a Psoriasis Area and Severity Index (PASI) 100 [Time frame: 12 and 24 months]
  • Proportion of Patients who Achieve a PASI Score ≤ 3 [Time frame: 12 and 24 months]
  • Cumulative Incidence of a ≥20% Relative Increase in Fibrosis-4 Index (FIB-4) From Baseline [Time frame: Baseline up to 5 years]
  • Proportion of Patients With a Shift in Fibrosis Category [Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months]
  • FIB-4 Score [Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months]
  • APRI Score [Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months]
  • AST Level [Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months]
  • ALT Level [Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months]
  • Platelet Count [Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months]
  • Correlation Between Changes in FIB-4 and Changes in PASI [Time frame: Baseline to 12 and 24 months]
  • Correlation Between Changes in APRI and Changes in PASI [Time frame: Baseline to 12 and 24 months]

Eligibility criteria

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.

Other protocol-defined inclusion/exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 3 centers
  • Novartis Investigative Site — Badalona
  • Novartis Investigative Site — Madrid
  • Novartis Investigative Site — Málaga

Identifiers

NCT: NCT07683065 · CAIN457AES18

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗