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

NCT05236777 | Completed FDA Drug

• 1 other identifier: CZ-TYS-12155
• Study Type: observational
• Target: 675
• Locations: 1 country
• Sites: 15

Brief 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

Keywords

Progressive Multifocal Leukoencephalopathy (PML)

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Up to 6 years

Secondary Outcomes (6)

• Number of Participants With SAEs

  Up to 6 years

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

  Up to 6 years

• Number 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

Study Arms (1)

Natalizumab Cohort

The cohort will include participants with MS who are newly treated with natalizumab (administered as a standard of care/routine clinical practice) from 1st January 2019 including those participants who terminate or discontinue the treatment during the observational period.

Drug: Natalizumab

Interventions

Natalizumab DRUG

Administered as specified in the treatment arm.

Also known as: Tysabri

Natalizumab Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include participants with MS who are treated with natalizumab from the 1st of January 2019 and participating in the Czech National MS registry (ReMuS).

You may qualify if:

• Participants starting with natalizumab after 1st January 2019 and participating in the ReMuS will be included in this study

You may not qualify if:

• Not Applicable (NA)

Sponsors & Collaborators

• Biogen: lead
• ReMuS Registry: collaborator

Study Sites (15)

Fakultní nemocnice Brno

Brno, Czechia

Location

Fakultní nemocnice u sv. Anny v Brně

Brno, Czechia

Location

Nemocnice České Budějovice

České Budějovice, Czechia

Location

Fakultní nemocnice Hradec Králové

Hradec Králové, Czechia

Location

Nemocnice Jihlava

Jihlava, Czechia

Location

Fakultní nemocnice Olomouc

Olomouc, Czechia

Location

Fakultní nemocnice v Ostravě

Ostrava, Czechia

Location

Nemocnice Pardubického kraje

Pardubice, Czechia

Location

Fakultní nemocnice v Plzni

Pilsen, Czechia

Location

Fakultní nemocnice Královské Vinohrady v Praze

Prague, Czechia

Location

Fakultní nemocniceMotol v Praze

Prague, Czechia

Location

Fakultní Thomayerova nemocnice v Praze v Krči

Prague, Czechia

Location

Všeobecná fakultní nemocnice v Praze

Prague, Czechia

Location

Nemocnice Teplice

Teplice, Czechia

Location

Krajská nemocnice T. Bati ve Zlíně

Zlín, Czechia

Location

MeSH Terms

Conditions

Multiple Sclerosis; Leukoencephalopathy, Progressive Multifocal

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Virus Diseases; Polyomavirus Infections; DNA Virus Infections; Slow Virus Diseases; Encephalitis; Brain Diseases; Central Nervous System Diseases; Leukoencephalopathies; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 11, 2022
• Study Start: January 1, 2019
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

CZ (15)