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Impact of the Arrival on the French Market of New First Line Oral Treatments on the Delay Between MS Onset and First Disease Modifying Treatment (DMTs) Administration

NCT03308994 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 650

Last updated 2020-10-22

No results posted yet for this study

Summary

The study design matches with a multicenter observational ambispective study. A first pilot study will be undertaken in Caen center and is expected to be extended to Rouen and Lille center. So patients from Normandy and North-West areas will be included.

In order to include patients in this observational study historical data about first line injectable treatments (interferons and glatiramer acetate) are used. As well as the data on patients treated with oral first line therapies (teriflunomide and dimethyl fumarate) began to be collected ahead of the study start (Retrospective phase). During the course of the study, new patients under teriflunomide or dimethyl fumarate will be included (Prospective phase).

Conditions

  • C10.114.375.500

Interventions

OTHER

Delay between MS onset and introduction of first line DMT

Delay between MS onset and introduction of first line DMT : time between date of MS onset ( the first demyelinating neurological events clinically defined) and date of the introduction of the first-line oral DMT (Interferons, Glatiramer Acetate, Dimethyl Fumarate and Teriflunomide)

OTHER

EDI

For all cases of multiple sclerosis residence's places of each patient were geolocalized with a Geographic Information System (ARCGIS 10.2) and assigned to an IRIS, IRIS (Ilots Regroupés pour l'Information Statistique) is the smallest French geographic unit for which census data are available and EDI score was calculated for each IRIS. In order to attribute a social deprivation score to the IRIS, we used the French EDI (European Deprivation Index). EDI stands as a continuous variable but EDI will be used as a categorical variable in order to increase the comparability with others studies, so EDI is distributed into quintiles calculated at the French level.

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • Ligue contre le cancer, France

    collaborator OTHER

  • University Hospital, Caen

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • France

Study Locations

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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 NCT03308994 on ClinicalTrials.gov