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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 (PREMISEP)

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ClinicalTrials.gov Identifier: NCT03308994
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : January 25, 2018
Sponsor:
Collaborators:
Genzyme, a Sanofi Company
Ligue contre le cancer, France
Information provided by (Responsible Party):
University Hospital, Caen

Brief 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).


Condition or disease Intervention/treatment
C10.114.375.500 Other: Delay between MS onset and introduction of first line DMT Other: EDI

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 650 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 2 Years
Official Title: 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
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Group/Cohort Intervention/treatment
Oral first line disease modifying treatments 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.

Injectable first line disease modifying treatments 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.




Primary Outcome Measures :
  1. Date of MS onset [ Time Frame: From date of the first neurological event to the end of the study in december 2018, as only date after 1982 were retained the time frame is up to 36 years. ]
    Date of the first neurological event. Only the date of MS onset after 1982 were retained.

  2. Date of introduction of first line DMT [ Time Frame: From date of the primo-prescription of a first injectable or oral first line DMT to the end of the study in december 2018. The time frame is up to 23 years. ]
    Date of the primo-prescription of a first injectable or oral first line DMT.

  3. Residence location [ Time Frame: To calculate EDI scores, addresses' of patients were required and were collected since EDMUS base was operational in 2004 until the end of the study. The time frame is up to 14 years. ]
    For all cases of multiple sclerosis residence's places of each patient were geo-localized 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. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
RRMS patients treated with oral or injectable first line DMT.
Criteria

Inclusion Criteria:

  • Patients registered in EDMUS database.
  • Patients with an initial and definite diagnosis of Relapsing-Remitting Multiple Sclerosis.
  • An established diagnosis from January 1st 1995 to the end of the study.

Exclusion Criteria:

  • Patients not registered in EDMUS database.
  • Patient with a diagnosis of Primary Progressive Multiple Sclerosis
  • Patients with a diagnosis established before January 1st 1995

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308994


Contacts
Contact: Gilles-Louis Defer, Professor 33231064617 defer-gi@chu-caen.fr
Contact: Floriane Calocer, PhD student 33231064617 calocer-f@chu-caen.fr

Locations
France
Groupement des Hôpitaux de l'Institut Catholique de Lille (HICL) Recruiting
Lille, Hauts-de-France, France, 59020
Contact: Arnaud Kwiatkowski, MD-PhD    33320874901    kwiatkowski.arnaud@ghicl.net   
University Hospital of Lille Recruiting
Lille, Hauts-de-France, France, 59037
Contact: Patrick Vermersch, Professor    33320445765    patrick.vermersch@univ-lille2.fr   
University Hospital Center of Caen Recruiting
Caen, Normandie, France, 14033
Contact: Gilles-Louis Defer, Professor    33231064617    defer-gi@chu-caen.fr   
Contact: Damien Chevanne, PhD    33231064617    chevanne-d@chu-caen.fr   
University Hospital of Rouen Recruiting
Rouen, Normandie, France, 76031
Contact: Bertrand Bourre, MD    33232888990    Bertrand.Bourre@chu-rouen.fr   
Sponsors and Collaborators
University Hospital, Caen
Genzyme, a Sanofi Company
Ligue contre le cancer, France

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03308994     History of Changes
Other Study ID Numbers: 16-913
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Caen:
Multiple sclerosis
Epidemiology
Oral disease modifying treatments
Therapeutical delays
Socio-Economical Status