To characterize the effect of Aubagio on the Cognitive status, measured by the Brief Repeatable Battery – neuropsychological (BRB-N battery) in RRMS patients
ID
Bron
Verkorte titel
Aandoening
Patients with Relapsing Remittent Multiple Sclerosis
Ondersteuning
Gooimeer 10, 1411 DD Naarden,The Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Change in cognitive status from baseline to 36 months, measured by the Brief Repeatable Battery – Neuropsychological (BRB-N)
Doel van het onderzoek
To characterize the effect of Aubagio on the Cognitive status, measured by the Brief Repeatable Battery – neuropsychological (BRB-N battery) in RRMS patients
Onderzoeksopzet
Estimated enrolment duration: 18 months
Estimated date for first patient in (FPI): Q3 2016
Estimated Last Patient In (LPI): Q1 2018
Estimated Last Patient Last Visit (LPLV): Q1 2021
Database lock: Q2 2021
Publication: Q3 2021
Onderzoeksproduct en/of interventie
none
Publiek
R. Hupperts
Sittard 6130 MB
The Netherlands
Wetenschappelijk
R. Hupperts
Sittard 6130 MB
The Netherlands
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5804 |
| NTR-old | NTR5959 |
| Ander register | : TERIFL07828 |