TOPIK Study: A Study to Report Progressive Multifocal Leukoencephalopathy and Other Serious Opportunistic Infections in Natalizumab Treated Participants
We could not find results for this trial
I know where the results areWhat it found
We found no results in the registry or in papers.
This trial finished 18 months ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Natalizumab
Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor
What it measured
Main measures
Number of Participants With Progressive Multifocal Leukoencephalopathy (PML) who are Taking Natalizumab
Up to 6 years
Number of Participants with Serious Adverse Events (SAEs) of Other Opportunistic Infections (OIs) who are Taking Natalizumab
Up to 6 years
Safety
Other measures (6)
Number of Participants With SAEs
Up to 6 years
SafetyNumber of Participants With SAEs Among Participant Subgroups Defined by Demographic and Clinical Factors
Up to 6 years
SafetyNumber of Participants With Malignancies who are Taking Natalizumab
Up to 6 years
Number of Participants With Hypersensitivity Reactions who are Taking Natalizumab
Up to 6 years
Number of Participants who are John Cunningham Virus (JCV) Positive and Taking Natalizumab
Up to 6 years
Number of Pregnant and Breastfeeding Participants who Were Previously Exposed to Natalizumab
Up to 6 years
Who could take part
MS (type not specified)
Key Inclusion Criteria: * Participants starting with natalizumab after 1st January 2019 and participating in the ReMuS will be included in this study Key Exclusion Criteria: * Not Applicable (NA) NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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 participants taking natalizumab. The secondary objectives of the study are to estimate the incidence of SAEs, to estimate the incidence of SAEs among participant subgroups defined by demographic and clinical factors (age, gender, duration of treatment, pregnancy, breastfeeding), to characterize and estimate incidences of malignancies, hypersensitivity reactions and John Cunningham Virus (JCV) positivity among all participants taking natalizumab, and to count and describe pregnancies and breastfeeding among participants previously exposed to natalizumab.
Papers
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History
Started
Jan 2019
Main results due
Apr 2025
Finished
Apr 2025
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