NCT05236777

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 675 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Natalizumab	Administered as specified in the treatment arm.

Timeline

• Start date: 2019-01-01
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2022-02-11
• Last updated: 2025-05-13

Locations

15 sites across 1 country: Czechia

Regulatory

• FDA-regulated drug study