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van CCT (UK)


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van CCT (UK)


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.


- candidate number24581
- NTR NumberNTR5959
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-jul-2016
- Secondary IDsTERIFL07828 
- Public TitleA 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.
- Scientific TitleA 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.
- ACRONYMCOMODO trial
- hypothesisTo characterize the effect of Aubagio on the Cognitive status, measured by the Brief Repeatable Battery – neuropsychological (BRB-N battery) in RRMS patients
- Healt Condition(s) or Problem(s) studiedMultiple sclerosis (MS)
- 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 criteriaSevere 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
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 15-aug-2016
- planned closingdate31-mrt-2021
- Target number of participants120
- Interventionsnone
- Primary outcomeChange in cognitive status from baseline to 36 months, measured by the Brief Repeatable Battery – Neuropsychological (BRB-N)
- Secondary outcome• 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
- TimepointsEstimated 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
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES R. Hupperts
- CONTACT for SCIENTIFIC QUERIES R. Hupperts
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
Sanofi
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD7-jul-2016 - 28-aug-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl