NCT04237337

Drugs for the Treatment of Multiple Sclerosis and Risk of Cancer: a Pharmacovigilance Analysis in Vigibase

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200,000 (estimated)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Even though the therapeutic panel for multiple sclerosis (MS) treatment has improved in the last 20 years, safety data especially for the second-line and innovative treatments are lacking. The association between MS and cancer has long been investigated but has led to conflicting results. No studies have reported an increased risk of cancer after long-term exposure to immuno-modulators. The present study will assess whether drugs for the treatment of MS are associated with an increased risk of cancer by analyzing the disproportionality of reports in the World Health Organization (WHO) pharmacovigilance database.

Detailed description

A case non-case study using Vigibase®, the World Health Organization Global Individual Case Safety Reports (ICSRs) database which includesreports forwarded to the WHO Uppsala Monitoring Center by national pharmacovigilance systems from over 130 countries around the world since 1967. Information on the adverse effects reported include patient demographics and medical relevant history, drugs recorded according to the WHO Drug dictionary and adverse drug reactions coded with Medical Dictionary for Regulatory Activities (MedDRA) terms will be perform.

Conditions

• Multiple Sclerosis
• Malignant Tumor

Interventions

Type	Name	Description
OTHER	Exposure to MS drugs	Exposure in ICSRs to MS drugs (dichotomous, exposed/not exposed), for each individual MS drug

Timeline

• Start date: 2020-01-01
• Primary completion: 2020-02-01
• Completion: 2020-03-01
• First posted: 2020-01-23
• Last updated: 2020-01-23