Clinical trial NCT04237337: Drugs for the Treatment of Multiple Sclerosis and Risk of Cancer: a Pharmacovigilance Analysis in Vigibase
Official title: Drugs for the Treatment of Multiple Sclerosis and Risk of Cancer: a Pharmacovigilance Analysis in Vigibase
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Malignant Tumor
Keywords: pharmacovigilance
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 200000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with a drug for the treatment of MS

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Serious cases reported in the World Health Organization (WHO) database of individual safety case report from 2000 to September 2019
* Cancer overall reported by a term included in the Standardized MedDRA query (SMQ) "Malignant tumours"

Exclusion Criteria:

- Non serious cases

Primary outcomes:
measure: Risk of reporting cancer overall specific cancers [ Time Frame: Reported in the World Health Organization (WHO) database of individual safety case reports from 2000 to 12/31/2019 ] performing a disproportionality analysis
timeFrame: 2000 to 2019
Secondary outcomes:
measure: Risk of reporting cancer specific cancers [ Time Frame: Reported in the World Health Organization (WHO) database of individual safety case reports from 2000 to 12/31/2019 ] performing a disproportionality analysis
timeFrame: 2000 to 2019
Other outcomes:
Locations:
Study officials:
References:
citation: Dolladille C, Chretien B, Peyro-Saint-Paul L, Alexandre J, Dejardin O, Fedrizzi S, Defer G. Association Between Disease-Modifying Therapies Prescribed to Persons with Multiple Sclerosis and Cancer: a WHO Pharmacovigilance Database Analysis. Neurotherapeutics. 2021 Jul;18(3):1657-1664. doi: 10.1007/s13311-021-01073-y. Epub 2021 Jul 6.