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 | Completed

• 1 other identifier: 16-913
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 4

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).

Conditions

C10.114.375.500

Keywords

Multiple sclerosis; Epidemiology; Oral disease modifying treatments; Therapeutical delays; Socio-Economic Status

Outcome Measures

Primary Outcomes (3)

• Date of MS onset

  Date of the first neurological event. Only the date of MS onset after 1982 were retained.

  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 introduction of first line DMT

  Date of the primo-prescription of a first injectable or oral first line DMT.

  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.

• Residence location

  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.

  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.

Study Arms (2)

Oral first line disease modifying treatments

Other: Delay between MS onset and introduction of first line DMT; Other: EDI

Injectable first line disease modifying treatments

Other: Delay between MS onset and introduction of first line DMT; Other: EDI

Interventions

Delay between MS onset and introduction of first line DMT OTHER

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)

Injectable first line disease modifying treatments; Oral first line disease modifying treatments

EDI OTHER

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; Oral first line disease modifying treatments

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

RRMS patients treated with oral or injectable first line DMT.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Caen: lead
• Genzyme, a Sanofi Company: collaborator
• Ligue contre le cancer, France: collaborator

Study Sites (4)

Groupement des Hôpitaux de l'Institut Catholique de Lille (HICL)

Lille, Hauts-de-France, 59020, France

Location

University Hospital of Lille

Lille, Hauts-de-France, 59037, France

Location

University Hospital Center of Caen

Caen, Normandy, 14033, France

Location

University Hospital of Rouen

Rouen, Normandy, 76031, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: October 13, 2017
• Study Start: November 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)