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

NCT05236777 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 675

Last updated 2025-05-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Natalizumab

Administered as specified in the treatment arm.

Sponsors & Collaborators

  • ReMuS Registry

    collaborator UNKNOWN

  • Biogen

    lead INDUSTRY

Principal Investigators

  • Medical Director · Biogen

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2025-04-30
Completion
2025-04-30
FDA Drug
Yes

Countries

  • Czechia

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05236777 on ClinicalTrials.gov