Status:
COMPLETED
A Study for Tysabri Participant Preference
Lead Sponsor:
Biogen
Conditions:
Relapsing-Remitting Multiple Sclerosis (RRMS)
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of this study is to collect, evaluate and compare data on participant preference between subcutaneous (SC) and intravenous (IV) natalizumab. The secondary objectives of this stud...
Eligibility Criteria
Inclusion
- Key
- Diagnosis of highly active RRMS according to McDonald criteria (2018) and initiating natalizumab treatment is indicated based on current summary of product characteristics (SmPC)
- In RRMS participants who are already on natalizumab therapy, continued treatment must be indicated based on current SmPC
- Key
Exclusion
- Progressive forms of MS
- Contraindication to natalizumab treatment according to natalizumab SmPC
- Concomitant treatment with other drugs for treating RRMS
- Participation in any interventional clinical trial NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
October 12 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
318 Patients enrolled
Trial Details
Trial ID
NCT05304520
Start Date
October 12 2021
End Date
April 30 2024
Last Update
May 17 2024
Active Locations (40)
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1
Neurozentrum am Königsplatz Augsburg; Dres. Müller und Schmid
Augsburg, Germany
2
Praxis Dr. Schöll
Bad Homburg, Germany
3
Caritas Krankenhaus Bad Mergentheim
Bad Mergentheim, Germany
4
Neurologische Praxis Dr. med. Boris-Alexander Kallmann
Bamberg, Germany