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NCT Number: NCT05236777

TOPIK Study: A Study to Report Progressive Multifocal Leukoencephalopathy and Other Serious Opportunistic Infections in Natalizumab Treated Participants

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Central Nervous System Diseases Central Nervous System Infections Central Nervous System Viral Diseases DNA Virus Infections Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Encephalitis Encephalitis, Viral Immune System Diseases Infections Infectious Encephalitis Leukoencephalopathies Leukoencephalopathy, Progressive Multifocal Nervous System Diseases Neuroinflammatory Diseases Polyomavirus Infections Slow Virus Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Fakultní nemocnice Brno, Brno, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Natalizumab

Drug

Administered as specified in the treatment arm.

Other names: Tysabri

Primary outcomes

  1. Number of Participants With Progressive Multifocal Leukoencephalopathy (PML) who are Taking Natalizumab

    Time frame: Up to 6 years

  2. Number of Participants with Serious Adverse Events (SAEs) of Other Opportunistic Infections (OIs) who are Taking Natalizumab

    Time frame: Up to 6 years

    SAE means such adverse event that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in permanent or significant damage to health or limitation of capabilities or is manifested as a congenital anomaly or birth defect in offspring, irrespective of the administered dose of the medicinal product. Serious OI means such OI which results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in permanent or significant damage to health or limitation of capabilities or is manifested as a birth defect in offspring.

Secondary outcomes

  1. Number of Participants With SAEs

    Time frame: Up to 6 years

    SAE means such adverse event that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in permanent or significant damage to health or limitation of capabilities or is manifested as a congenital anomaly or birth defect in offspring, irrespective of the administered dose of the medicinal product.

  2. Number of Participants With SAEs Among Participant Subgroups Defined by Demographic and Clinical Factors

    Time frame: Up to 6 years

    SAE means such adverse event that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in permanent or significant damage to health or limitation of capabilities or is manifested as a congenital anomaly or birth defect in offspring, irrespective of the administered dose of the medicinal product. Demographic and clinical factors involve age, gender, duration of treatment, pregnancy, breastfeeding.

  3. Number of Participants With Malignancies who are Taking Natalizumab

    Time frame: Up to 6 years

  4. Number of Participants With Hypersensitivity Reactions who are Taking Natalizumab

    Time frame: Up to 6 years

  5. Number of Participants who are John Cunningham Virus (JCV) Positive and Taking Natalizumab

    Time frame: Up to 6 years

  6. Number of Pregnant and Breastfeeding Participants who Were Previously Exposed to Natalizumab

    Time frame: Up to 6 years

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Collaborators

  • ReMuS Registry

Registry information

Official study title

Long-term Surveillance of Patients With Multiple Sclerosis to Report Progressive Multifocal Leukoencephalopathy and Other Serious Opportunistic Infections Among Patients Treated With Natalizumab

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2022
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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