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

NCT04237337 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200000

Last updated 2020-01-23

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Exposure to MS drugs

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

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2020-02-29
Completion
2020-03-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04237337 on ClinicalTrials.gov