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Completed

NCT Number: NCT06705608

Examining the Risk of Skin Cancer in Multiple Sclerosis Patients Using Fingolimod: a Population-Based Study

The goal of this retrospective observational study is to investigate the long-term safety of Fingolimod in individuals with Multiple Sclerosis (MS), specifically focusing on the risk of developing skin cancer. The main question it aims to answer is:

• Does the use of Fingolimod increase the incidence of skin cancer in individuals with MS compared to those using other disease-modifying therapies? Participants who are new users of Fingolimod or other active comparators as part of their regular medical care for MS will be included in this study. Researchers will use advanced causal inference techniques to analyze healthcare data and compare the incidence of skin cancer between these groups.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Carcinoma Carcinoma, Basal Cell Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Melanoma Multiple Sclerosis (MS) - Relapsing-remitting Multiple Sclerosis, Relapsing-Remitting Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Basal Cell Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Nervous System Diseases Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Cancer Skin Cancer Melanoma Skin Cancer, Squamous Cell Skin Cancers - Basal Cell Carcinoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Identified MS cohort with hospital/physician and prescription claims classified according to the international classification of disease codes and drug identification numbers respectively, using a validated case definition. This case definition requires an individual to have at least three health care encounters (any combination of inpatient encounter, outpatient encounter, or DMT dispensation) for MS in a 1-year window
  • MS patients who initiated and used fingolimod, natalizumab, alemtuzumab, dimethyl fumarate, or teriflunomide as monotherapy following MS identification.

Exclusion criteria

  • Pediatric (<18 years old) MS cases.
  • MS cases with less than three years of baseline data before the first drug dispensation.
  • MS cases with skin cancer in the three-year baseline period

Treatment and study plan

Fingolimod

Drug

patients who received fingolimod for treating RRMS

Natalizumab

Drug

patients who received natalizumab for treating RRMS (active comparator)

Dimethyl Fumarate (DMF)

Drug

patients who received dimethyl fumarate for treating RRMS (active comparator)

Alemtuzumab

Drug

patients who received alemtuzumab for treating RRMS (active comparator)

Teriflunomide

Drug

patients who received teriflunomide for treating RRMS (active comparator)

Primary outcomes

  1. Number of participants who developed skin cancer

    Time frame: From Index drug dispensation to the first of the following events, whichever occurred first: development of skin cancer; lost to follow-up; death; administrative end of follow-up; initiation of a comparator drug, assessed up to 180 months.

    In this outcome measure, participants who developed skin cancer after receiving the respective DMT treatments are reported. ICD 9/10 codes were used for the diagnosis of skin cancer (melanoma and non-melanoma skin cancers). Skin cancers were treated as a composite outcome of basal cell carcinoma, squamous cell carcinoma, and melanoma, as well as disaggregated by skin cancer subtypes.

  2. Time to development of skin cancer

    Time frame: From Index drug dispensation to the first of the following events, whichever occurred first: development of skin cancer; lost to follow-up; death; administrative end of follow-up; initiation of a comparator drug, assessed up to 180 months.

    Time to development of skin cancer is defined as the time from the index date (drug initiation) to the development of skin cancer. ICD 9/10 codes were used for the diagnosis of skin cancer (melanoma and non-melanoma skin cancers). Skin cancers were treated as a composite outcome of basal cell carcinoma, squamous cell carcinoma, and melanoma, as well as disaggregated by skin cancer subtypes.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

Fingolimod and Risk of Skin Cancer Among Individuals with Multiple Sclerosis: a Population-based Cohort Study

Acronym: MS; FTY720

Important dates

Study start
2003
Primary completion
2020
Study completion
2020
First posted
Nov 26, 2024
Registry last updated
Nov 26, 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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