Patients with Relapsing Remittent Multiple Sclerosis
Conditions
Interventions
none
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: • Patients with RRMS according the McDonald criteria 2010 and approved SmPC of Aubagio • Treatment naïve RRMS patients or currently being treated with Aubagio for no more than 2 month or previously treated (with other first-line DMDs) with a wash-out period according to the respective SmPC before starting Aubagio. (verification has occurred prior to study enrollment) • EDSS score ≤ 4 • Patients who are willing and able to sign written consent
Exclusion criteria
Exclusion criteria: Severe disability and/or any neurological or severe psychiatric disorder, history of alcohol/ drugs abuse, history of traumatic brain injury with residual symptoms which might interfere with cognitive performance and other questionnaire outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in cognitive status from baseline to 36 months, measured by the Brief Repeatable Battery – Neuropsychological (BRB-N) | — |
Secondary
| Measure | Time frame |
|---|---|
| • change in cognitive status measured by the BRB-N from baseline to month 12 and 24 • change in mood measured by the HADS from baseline to month 12 – 24 – 36 • change in fatigue measured by the MFIS from baseline to month 12 – 24 – 36 • change in QoL measured by MSIS-29 from baseline to month 12 – 24 – 36 • Pairwise Correlation within the time points baseline – M12 – M24 – M36 between: o Cognitive status and mood o Cognitive status and fatigue o Cognitive status and Quality of Life • (serious) Adverse events | — |
Contacts
Public ContactR. Hupperts
Postbus 5500
Outcome results
None listed