Multiple SclerosisPVSEPKNCT04237337
Drugs for the Treatment of Multiple Sclerosis and Risk of Cancer: a Pharmacovigilance Analysis in Vigibase
An observational study of Multiple Sclerosis and Malignant Tumor, run by University Hospital, Caen.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis, Malignant Tumor
- What is being tested?
- Exposure to MS drugs
- How many people
- 200,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated with a drug for the treatment of MS
Who may be able to join
- 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"
Who cannot join
- Non serious cases
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Being tested
- Exposure to MS drugs
- Keywords
- pharmacovigilance
- Medical subject headings
- Multiple Sclerosis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to MS drugsOther
Exposure in ICSRs to MS drugs (dichotomous, exposed/not exposed), for each individual MS drug
| Study group | Role | What they receive |
|---|---|---|
| serious cancer ICSRs (cases) | Not described Receives: Other: Exposure to MS drugs | |
| other serious reactions ICSRs (non-cases) | Not described Receives: Other: Exposure to MS drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- Risk of reporting cancer overall and for specific cancer types (including breast, lung, lymphoma, cervical, melanoma and NMSC) with a specific drug of MS (β-interferon, glatiramer acetate, fumaric acid, teriflunomide, fingolimod, natalizumab, ocrelizumab or alemtuzumab) compared with the others drugs of MS
Measured: 2000 to 2019
Secondary outcomes (1)
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
- Risk of reporting cancer specific cancer types with a specific drug of MS compared with all other non-MS drugs performing a disproportionality analysis
Measured: 2000 to 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study startJan 2020 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237337
- Sponsor's protocol ID
- 2019-PVSEP
- Acronym
- PVSEPK
- Status last verified
- Dec 2019
- First submitted
- 7 Jan 2020
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34231126
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drugs for the Treatment of Multiple Sclerosis and Risk of Cancer: a Pharmacovigilance Analysis in Vigibase
- ClinicalTrials.gov ID
- NCT04237337
- Acronym / sponsor ID
- PVSEPK / 2019-PVSEP
- Conditions
- Multiple Sclerosis, Malignant Tumor
- Keywords
- pharmacovigilance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| serious cancer ICSRs (cases) | – | Other: Exposure to MS drugs |
| other serious reactions ICSRs (non-cases) | – | Other: Exposure to MS drugs |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated with a drug for the treatment of MS
Key inclusion criteria (2 listed)
- 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"
Key exclusion criteria (1 listed)
- Non serious cases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure to MS drugsExposure in ICSRs to MS drugs (dichotomous, exposed/not exposed), for each individual MS drug | Other | other serious reactions ICSRs (non-cases), serious cancer ICSRs (cases) |
Primary outcome
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
Time frame: 2000 to 2019
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 (β-interferon, glatiramer acetate, fumaric acid, teriflunomide, fingolimod, natalizumab, ocrelizumab or alemtuzumab) compared with the others drugs of MS
1 secondary outcome
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
Time frame: 2000 to 2019
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Derived from this study: PubMed 34231126Dolladille 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Malignant Tumor, run by University Hospital, Caen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laure Peyro-Saint-Paul, PharmD (33231065342, peyrosaintpaul-l@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 2000 to 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04237337, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.