Multiple SclerosisVigiP-SEPNCT03029897
E-reporting of Adverse Drug Reactions by Patients in Relapsing-remitting Multiple Sclerosis
A study testing My eReport France in people with Multiple Sclerosis, run by University Hospital, Caen at 1 site in France.
Trial summary
Adverse drug reactions are collected exhaustively during the experimental development phase of the drug, but the trial population is not representative. In post-marketing authorization, the use in the real life of medicines requires to specify the profile of adverse effects through pharmacovigilance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- My eReport France
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2017to 24 Apr 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient (> 18 years) with relapsing-remitting multiple sclerosis. Initiation of treatment of 1st line: interferon β, peginterferon β, glatiramer acetate, teriflunomide, dimethyl-fumarate.
Who cannot join
- Patient with progressively progressive secondary or multiple sclerosis. Patient suffering from multiple sclerosis not treated with a first line treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of E-reporting by Patients With Relapsing-remitting Multiple Sclerosis on the Reporting of Adverse Drug Reactions in France: a Randomized Controlled Trial.
Adverse drug reactions are collected exhaustively during the experimental development phase of the drug, but the trial population is not representative. In post-marketing authorization, the use in the real life of medicines requires to specify the profile of adverse effects through pharmacovigilance. However, in clinical practice, under-reporting of adverse drug reactions prevents a satisfactory knowledge of the risks. For example, in the multiple sclerosis (MS) patients population in 2015, only 1 case of congestive flushing was reported by physicians, none by patients, for approximately 7,800 patients treated with Tecfidera® dimethyl-fumarate, while trials reported 39% of flush.
The investigators propose a study measuring the impact of the deployment of e-reporting to patients in a population suffering from multiple sclerosis in initiation of first line drug therapy. The study design will be a randomized controlled trial. Twenty-four direct or indirect partner centers of the OFSEP will be randomized in 2 arms (1 standard arm without intervention, and one interventional arm), Each arm including 6 CHU, 3 CHG and 3 liberal neurologists. CHUs will include 10 patients in 6 months, and CHGs and liberal neurologists 5 patients, a total of 180 patients will be included. The expected duration of this study is 12 months, 6 months of inclusion of patients, and one 6-month follow-up period for each patient. At 1 month (+/- 15 days) of the follow-up period of each patient, a questionnaire will be made by telephone call to each patient.
Read more
The study is part of the pharmacovigilance system in place in France and aims to improve its efficiency by increasing declarations and therefore earlier detection of signals in order to prevent and minimize risks.
The comparison of the two arms should make it possible to decide on the usefulness of national support for e-reporting, while respecting a good integration with the French pharmacovigilance system.
- Conditions
- Multiple Sclerosis
- Being tested
- My eReport France
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My eReport FranceOther
patients are educated to the use of "My eReport France" application
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Patients are educated on the use of a mobile application to report adverse drug reactions Receives: Other: My eReport France |
| control | No intervention | Patients are not educated on the use of a mobile application to report adverse drug reactions |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of reports of adverse drug reactions
number of reports of adverse drug reactions per patient in the intervention arm using mobile versus standard arm.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start5 May 2017
- Primary completion24 Apr 2019
- Study completion24 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- clusters
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029897
- Sponsor's protocol ID
- 16-135
- Acronym
- VigiP-SEP
- Status last verified
- Apr 2018
- First submitted
- 20 Jan 2017
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Defer G, Fedrizzi S, Chevanne D, Montastruc F, Briant AR, Parienti JJ, Peyro-Saint-Paul L; French VigipSEP Study Group; Societe Francophone de la Sclerose en Plaques (SFSEP). Adverse Drug Reaction Reporting Using a Mobile Device Application by Persons with Multiple Sclerosis: A Cluster Randomized Controlled Trial. Drug Saf. 2021 Feb;44(2):223-233. doi: 10.1007/s40264-020-01009-z. Epub 2020 Oct 13.
PubMed 33048319Defer G, Le Caignec F, Fedrizzi S, Montastruc F, Chevanne D, Parienti JJ, Peyro-Saint-Paul L. Dedicated mobile application for drug adverse reaction reporting by patients with relapsing remitting multiple sclerosis (Vigip-SEP study): study protocol for a randomized controlled trial. Trials. 2018 Mar 9;19(1):174. doi: 10.1186/s13063-018-2560-4.
PubMed 29523169
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of E-reporting by Patients With Relapsing-remitting Multiple Sclerosis on the Reporting of Adverse Drug Reactions in France: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03029897
- Acronym / sponsor ID
- VigiP-SEP / 16-135
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 5 May 2017 (actual)
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 24 Apr 2019 (actual)
- First posted
- 24 Jan 2017 (estimated)
- 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.
Adverse drug reactions are collected exhaustively during the experimental development phase of the drug, but the trial population is not representative. In post-marketing authorization, the use in the real life of medicines requires to specify the profile of adverse effects through pharmacovigilance. However, in clinical practice, under-reporting of adverse drug reactions prevents a satisfactory knowledge of the risks. For example, in the multiple sclerosis (MS) patients population in 2015, only 1 case of congestive flushing was reported by physicians, none by patients, for approximately 7,800 patients treated with Tecfidera® dimethyl-fumarate, while trials reported 39% of flush.
The investigators propose a study measuring the impact of the deployment of e-reporting to patients in a population suffering from multiple sclerosis in initiation of first line drug therapy. The study design will be a randomized controlled trial. Twenty-four direct or indirect partner centers of the OFSEP will be randomized in 2 arms (1 standard arm without intervention, and one interventional arm), Each arm including 6 CHU, 3 CHG and 3 liberal neurologists. CHUs will include 10 patients in 6 months, and CHGs and liberal neurologists 5 patients, a total of 180 patients will be included. The expected duration of this study is 12 months, 6 months of inclusion of patients, and one 6-month follow-up period for each patient. At 1 month (+/- 15 days) of the follow-up period of each patient, a questionnaire will be made by telephone call to each patient.
The study is part of the pharmacovigilance system in place in France and aims to improve its efficiency by increasing declarations and therefore earlier detection of signals in order to prevent and minimize risks.
The comparison of the two arms should make it possible to decide on the usefulness of national support for e-reporting, while respecting a good integration with the French pharmacovigilance system.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- clusters
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Other: My eReport FrancePatients are educated on the use of a mobile application to report adverse drug reactions |
| control | No intervention | –Patients are not educated on the use of a mobile application to report adverse drug reactions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient (> 18 years) with relapsing-remitting multiple sclerosis. Initiation of treatment of 1st line: interferon β, peginterferon β, glatiramer acetate, teriflunomide, dimethyl-fumarate.
Key exclusion criteria (1 listed)
- Patient with progressively progressive secondary or multiple sclerosis. Patient suffering from multiple sclerosis not treated with a first line treatment.
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 |
|---|---|---|
| My eReport Francepatients are educated to the use of "My eReport France" application | Other | experimental |
Primary outcome
number of reports of adverse drug reactions
Time frame: 6 months
number of reports of adverse drug reactions per patient in the intervention arm using mobile versus standard arm.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Derived from this study: PubMed 33048319Defer G, Fedrizzi S, Chevanne D, Montastruc F, Briant AR, Parienti JJ, Peyro-Saint-Paul L; French VigipSEP Study Group; Societe Francophone de la Sclerose en Plaques (SFSEP). Adverse Drug Reaction Reporting Using a Mobile Device Application by Persons with Multiple Sclerosis: A Cluster Randomized Controlled Trial. Drug Saf. 2021 Feb;44(2):223-233. doi: 10.1007/s40264-020-01009-z. Epub 2020 Oct 13.
- Derived from this study: PubMed 29523169Defer G, Le Caignec F, Fedrizzi S, Montastruc F, Chevanne D, Parienti JJ, Peyro-Saint-Paul L. Dedicated mobile application for drug adverse reaction reporting by patients with relapsing remitting multiple sclerosis (Vigip-SEP study): study protocol for a randomized controlled trial. Trials. 2018 Mar 9;19(1):174. doi: 10.1186/s13063-018-2560-4.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My eReport France in people with Multiple Sclerosis, run by University Hospital, Caen at 1 site in France.
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 1 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: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of reports of adverse drug reactions (time frame: 6 months). 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 NCT03029897, which also lists 2 linked publications.
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 2 Jul 2019.