G35.1
Conditions
Interventions
Group 1: Diroximel Fumarate
Group 2: Dimethyl Fumarate
Sponsors
Biogen GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Established clinical diagnosis of relapsing-remitting MS 2. Able to understand the purpose and risks of the study, ability and willingness to follow study procedures, and provide signed and dated study-specific informed consent form (ICF) 3. Having been prescribed treatment with Vumerity (DRF) or Tecfidera (DMF) according to label and local market reimbursement criteria and treatment is planned to be initiated within 30 days after enrollment or already initiated, with enrollment occurring no more than 30 days after the first dose. 4. Patients aged 18 years or above
Exclusion criteria
Exclusion criteria: 1. Contraindication to dimethyl or diroximel fumarate treatment according to SmPC 2. Unable or unwilling to provide informed consent 3. Progressive forms of MS 4. Have received the newly prescribed treatment with DRF / DMF for more than 30 days 5. Have been prescribed another DMF than Tecfidera
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number and proportion of patients confirming their treatment decision for DRF after one year of treatment / end of study (EOS) as well as their reasoning. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Number and proportion of patients confirming their treatment decision for DMF after one year of treatment / EOS as well as their reasoning - Drivers for initiation or switch to DRF or DMF respectively via patient preference questionnaire at baseline - Drivers for switch from DMF to DRF via patient preference questionnaire at baseline - Number and proportion of patients on treatment with DRF or DMF respectively at 1 year / EOS - Number and proportion of patients withdrawing from the study after each study visit. - Average study duration - Number and proportion of patients participating in PSP at least during part of the study - Reasons for PSP participation and for non-PSP participation (number and proportion of patients) - For patient participating in PSP only: number and proportion of completing patients - For patient participating in PSP only: number and proportion of prematurely withdrawing patients in PSP - Description of PSP offered by sites - Number and proportion of patients taking the fumarate capsules always / sometimes / never with food (all visits) - Number and proportion of patients adjusting their eating habits because of the fumarate therapy (all visits) - For patients with nutrition changes: Number and proportion of patients recording the following reasons according to the patient questionnaire - For patients with nutrition changes: Number and proportion of patients recording changes according to the patient questionnaire - Mean change in TSQM-II score from baseline to 1 year (or last value) - Mean change in EQ5D-5L score from baseline (or last value on previous DMT) to 1 year (or last value) - Characterization of titration strategies followed by sites - Description of way of drug intake recommended by sites - Number and proportion of sites in which the Treating physician / MS nurse / Treating physician AND MS nurse / PSP coach / Other is responsible for the patient’s education (site questionnaire) - Number and proportion o | — |
Countries
Germany
Contacts
Public ContactSilke Heeren
CLINVICES GmbH
Outcome results
None listed