A prospective, open-label, non-interventional phase IV study to investigate the COgnitive status, MOod, fatigue and quality of life in relapsing remitting multiple sclerosis patients treated with teriflunomide (Aubagio®) in Daily routine Observational Setting.
- Conditions
- Patients with Relapsing Remittent Multiple Sclerosis
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 120
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)
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in cognitive status from baseline to 36 months, measured by the Brief Repeatable Battery – Neuropsychological (BRB-N)
- Secondary Outcome Measures
Name Time Method • change in cognitive status measured by the BRB-N from baseline to month 12 and 24<br /><br>• change in mood measured by the HADS from baseline to month 12 – 24 – 36 <br /><br>• change in fatigue measured by the MFIS from baseline to month 12 – 24 – 36 <br /><br>• change in QoL measured by MSIS-29 from baseline to month 12 – 24 – 36 <br /><br>• Pairwise Correlation within the time points baseline – M12 – M24 – M36 between:<br /><br>oCognitive status and mood<br /><br>oCognitive status and fatigue<br /><br>oCognitive status and Quality of Life<br /><br>•(serious) Adverse events<br>