NCT06705608

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Multiple Sclerosis
• Skin Cancer
• Skin Cancer Melanoma
• Skin Cancers - Basal Cell Carcinoma
• Skin Cancer, Squamous Cell
• Multiple Sclerosis (MS) - Relapsing-remitting

Interventions

Type	Name	Description
DRUG	Fingolimod	patients who received fingolimod for treating RRMS
DRUG	Natalizumab	patients who received natalizumab for treating RRMS (active comparator)
DRUG	Dimethyl fumarate (DMF)	patients who received dimethyl fumarate for treating RRMS (active comparator)
DRUG	Alemtuzumab	patients who received alemtuzumab for treating RRMS (active comparator)
DRUG	Teriflunomide	patients who received teriflunomide for treating RRMS (active comparator)

Timeline

• Start date: 2003-01-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2024-11-26
• Last updated: 2024-11-26

Regulatory

• FDA-regulated drug study