TOPIK Study: A Study to Report Progressive Multifocal Leukoencephalopathy and Other Serious Oppor… (NCT05236777) | Clinical Trial Compass
CompletedNot Applicable
TOPIK Study: A Study to Report Progressive Multifocal Leukoencephalopathy and Other Serious Opportunistic Infections in Natalizumab Treated Participants
Czechia675 participantsStarted 2019-01-01
Plain-language 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 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study tracked serious brain infections like PML in people taking natalizumab — what does the data collected in this type of registry study mean for my personal risk if I'm considering natalizumab as a treatment for my MS?
2Since this study specifically monitored for PML and other opportunistic infections in natalizumab users, are there risk factors like JC virus antibody status that my doctor would check before or during natalizumab treatment?
3This was an observational study rather than a treatment trial — does the real-world safety information it gathered change how you would monitor me if I were on natalizumab, and how often would that monitoring happen?
4Given that this study focused on serious opportunistic infections beyond just PML, are there other infections I should be aware of that have been associated with natalizumab, and how would we watch for signs of those?
5Since this study is now completed, would it be worth asking whether its findings have influenced any updated guidelines or risk-management strategies around natalizumab, and whether standard therapies might be a safer starting point for someone in my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Progressive Multifocal Leukoencephalopathy (PML) who are Taking Natalizumab
Timeframe: Up to 6 years
2
Number of Participants with Serious Adverse Events (SAEs) of Other Opportunistic Infections (OIs) who are Taking Natalizumab