Real-world Secukinumab Outcomes in Canadian HS Patients

Official title

A Prospective Study to Describe the Real-world Treatment Outcomes in Canadian Patients With Moderate-to-severe Hidradenitis Suppurativa Treated With secukInumab (HS-RISE)

Overview

The HS-RISE study aims to assess real-world HS treatment outcomes and patterns, safety of secukinumab, and to describe the baseline characteristics of patients diagnosed with moderate-to- severe HS who are prescribed secukinumab in Canadian routine clinical practice.

Primary outcome measures

• Proportion of patients who experience a change in disease severity classification [Time frame: Baseline, month 12]

Secondary outcome measures (12)

• Proportion of patients overall who experience a change in disease severity classification [Time frame: Baseline, Month 3, Month 6]
• Proportion of patients achieving a 55% reduction in International HS Severity Score System (IHS4-55) [Time frame: Baseline, Month 3, Month 6, Month 12]
• Proportion of patients experiencing HS Clinical Response 50 (HiSCRO50) [Time frame: Baseline, Month 3, Month 6, Month 12]
• Mean reduction in abscess and inflammatory nodule count [Time frame: Baseline, Month 3, Month 6, Month 12]
• Descriptive summaries of demographic and clinical variables [Time frame: Baseline]
• Proportion of patients receiving secukinumab up-titration from every 4 weeks (Q4W) to every 2 weeks (Q2W) [Time frame: Month 3, Month 6, Month 12]
• Proportion of patients receiving secukinumab down-titration from every 2 weeks (Q2W) to every 4 weeks (Q4W) [Time frame: Month 3, Month 6, Month 12]
• Time to secukinumab up- and down-titration [Time frame: Month 3, Month 6, Month 12]
• Proportion of patients experiencing adverse events post-secukinumab initiation [Time frame: Up to 12 Months]
• Proportion of patients experiencing serious adverse events post-secukinumab initiation [Time frame: Up to 12 Months]
• Type of adverse events and serious adverse events experienced by patients post-secukinumab initiation [Time frame: Up to 12 Months]
• Proportion of patients who discontinued secukinumab due to adverse events [Time frame: Up to 12 Months]

Eligibility criteria

Inclusion criteria

• Patients must give written, signed, and dated informed consent before any information is collected and any study-related activity is performed.
• Adult patients at the time of informed consent signature.
• Patients with the diagnosis of moderate-to-severe HS, as determined by the dermatologist.
• Patients who have been newly prescribed secukinumab as part of routine clinical care according to the approved Canadian PM. The decision to prescribe secukinumab must be made prior to,and independent of, study participation. First treatment with secukinumab must occur no more than 7 days (≤7 days) prior to Baseline visit.
• Patients who can understand written and spoken Canadian English or French.

Exclusion criteria

• Any medical or psychological condition in the treating physician's opinion that may prevent the patient from study participation.
• Patients who have any contraindications to treatment with secukinumab, as defined in the Canadian PM.
• Patients who have had any prior exposure to secukinumab (i.e., >7 days prior to the baseline visit).

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

Canada · 15 centers

• Novartis Investigative Site — Calgary
• Novartis Investigative Site — Calgary
• Novartis Investigative Site — Winnipeg
• Novartis Investigative Site — Fredericton
• Novartis Investigative Site — St. John's
• Novartis Investigative Site — Cobourg
• Novartis Investigative Site — Hamilton
• Novartis Investigative Site — London
• … and 7 more centers

Identifiers

NCT: NCT07282015 · CAIN457MCA01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗