Status:
COMPLETED
TOPIK Study: A Study to Report Progressive Multifocal Leukoencephalopathy and Other Serious Opportunistic Infections in Natalizumab Treated Participants
Lead Sponsor:
Biogen
Collaborating Sponsors:
ReMuS Registry
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
Brief Summary
The primary objective of the study is to estimate the incidence of progressive multifocal leukoencephalopathy (PML) and serious adverse events (SAEs) of other opportunistic infections (OIs) among all ...
Eligibility Criteria
Inclusion
- Key
- Participants starting with natalizumab after 1st January 2019 and participating in the ReMuS will be included in this study
- Key
Exclusion
- Not Applicable (NA)
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2025
Estimated Enrollment :
675 Patients enrolled
Trial Details
Trial ID
NCT05236777
Start Date
January 1 2019
End Date
April 30 2025
Last Update
May 13 2025
Active Locations (15)
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1
Fakultní nemocnice Brno
Brno, Czechia
2
Fakultní nemocnice u sv. Anny v Brně
Brno, Czechia
3
Nemocnice České Budějovice
České Budějovice, Czechia
4
Fakultní nemocnice Hradec Králové
Hradec Králové, Czechia