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

NCT ID: NCT05236777

Last Updated: 2025-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

675 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2025-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Natalizumab

Intervention Type DRUG

Administered as specified in the treatment arm.

Interventions

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Natalizumab

Administered as specified in the treatment arm.

Intervention Type DRUG

Other Intervention Names

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Tysabri

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Not Applicable (NA)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ReMuS Registry

UNKNOWN

Sponsor Role collaborator

Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Fakultní nemocnice Brno

Brno, , Czechia

Site Status

Fakultní nemocnice u sv. Anny v Brně

Brno, , Czechia

Site Status

Nemocnice České Budějovice

České Budějovice, , Czechia

Site Status

Fakultní nemocnice Hradec Králové

Hradec Králové, , Czechia

Site Status

Nemocnice Jihlava

Jihlava, , Czechia

Site Status

Fakultní nemocnice Olomouc

Olomouc, , Czechia

Site Status

Fakultní nemocnice v Ostravě

Ostrava, , Czechia

Site Status

Nemocnice Pardubického kraje

Pardubice, , Czechia

Site Status

Fakultní nemocnice v Plzni

Pilsen, , Czechia

Site Status

Fakultní nemocnice Královské Vinohrady v Praze

Prague, , Czechia

Site Status

Fakultní nemocniceMotol v Praze

Prague, , Czechia

Site Status

Fakultní Thomayerova nemocnice v Praze v Krči

Prague, , Czechia

Site Status

Všeobecná fakultní nemocnice v Praze

Prague, , Czechia

Site Status

Nemocnice Teplice

Teplice, , Czechia

Site Status

Krajská nemocnice T. Bati ve Zlíně

Zlín, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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CZ-TYS-12155

Identifier Type: -

Identifier Source: org_study_id

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