Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation
Effectiveness study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(L04AX07) dimethyl fumarate
dimethyl fumarate

Medical condition to be studied

Relapsing-remitting multiple sclerosis
Population studied

Short description of the study population

Adults patients with relapsing-remitting multiple sclerosis forms receiving Tecfidera® and other oral drugs including Aubagio® and Gilenya® identified from the SNIIRAM nationwide claims and hospital database.

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Other

Special population of interest, other

Patients with relapsing-remitting multiple sclerosis

Estimated number of subjects

62000
Study design details

Main study objective

To assess the effectiveness of Tecfidera® on the frequency of relapses compared to the two other oral drugs (Aubagio® and Gilenya®), as well as injectable immunomodulatory drugs (IID) (Avonex®, Betaferon®, Copaxone®, Rebif®, Extavia®, Plegridy®).

Outcomes

The primary outcome is the number of relapses occuring during the follow-up. The secondary outcome is the progression of disability defined as a reimbursed dispensation of equipment for disability, long-term sick leave and daily allowance, disability status and allowance.

Data analysis plan

The statistical analysis will be performed using the SAS software (latest current version), following a detailed statistical analysis plan.The following analyses will be performed according to the treatment group at index date for all patients and according to naïve non-naïve status of patients :- Description of baseline characteristics, with standardised difference before and after adjustment on potential confounding defined above- hdPS will be calculated using a logistic regression model taking into account information defined above- Description of primary outcome adjusted on potential confounding defined above- Description of the follow-up and drug exposure duration, as well as MS drug use - Description of the switch to another MS treatment, according the occurrence of a relapse or not- Description of healthcare resources use for MS and their related costs during the follow-up