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

Multiple Sclerosis Clinical Trial

— PVSEPK  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04237337
• Other study ID #: 2019-PVSEP
• Status: Not yet recruiting
• Start date: January 2020
• Est. completion date: March 2020

Study information

• Verified date: December 2019
• Source: University Hospital, Caen
• Contact: Laure Peyro-Saint-Paul, PharmD
• Phone: 33231065342
• Email: peyrosaintpaul-l[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200000
• Est. completion date: March 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Tumor
• Multiple Sclerosis
• Neoplasms
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	o Risk of reporting cancer overall and for specific cancer types (including breast, lung, lymphoma, cervical, melanoma and NMSC) with a specific drug of MS (ß-interferon, glatiramer acetate, fumaric acid, teriflunomide, fingolimod, natalizumab, ocrelizumab or alemtuzumab) compared with the others drugs of MS	2000 to 2019
Secondary	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	o Risk of reporting cancer specific cancer types with a specific drug of MS compared with all other non-MS drugs performing a disproportionality analysis	2000 to 2019