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

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Natalizumab

• Registration Number: NCT05236777
• Lead Sponsor: Biogen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2022-02-02
• Study First Submitted QC: 2022-02-02
• Study First Posted: 2022-02-11
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 675

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Natalizumab Cohort	Natalizumab	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Serious Adverse Events (SAEs) of Other Opportunistic Infections (OIs) who are Taking Natalizumab	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.
Number of Participants With Progressive Multifocal Leukoencephalopathy (PML) who are Taking Natalizumab	Up to 6 years

Secondary Outcome Measures

Name	Time	Method
Number of Participants With SAEs	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.
Number of Participants With SAEs Among Participant Subgroups Defined by Demographic and Clinical Factors	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.
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
Number of Pregnant and Breastfeeding Participants who Were Previously Exposed to Natalizumab	Up to 6 years

Trial Locations

Locations (15)

Fakultní nemocnice v Plzni; 🇨🇿 Pilsen, Czechia

Fakultní nemocnice Olomouc; 🇨🇿 Olomouc, Czechia

Fakultní nemocnice v Ostravě; 🇨🇿 Ostrava, Czechia

Nemocnice Pardubického kraje; 🇨🇿 Pardubice, Czechia

Fakultní nemocnice Brno; 🇨🇿 Brno, Czechia

Fakultní nemocnice u sv. Anny v Brně; 🇨🇿 Brno, Czechia

Fakultní nemocnice Hradec Králové; 🇨🇿 Hradec Králové, Czechia

Nemocnice Jihlava; 🇨🇿 Jihlava, Czechia

Fakultní nemocnice Královské Vinohrady v Praze; 🇨🇿 Prague, Czechia

Fakultní nemocniceMotol v Praze; 🇨🇿 Prague, Czechia

Fakultní Thomayerova nemocnice v Praze v Krči; 🇨🇿 Prague, Czechia

Všeobecná fakultní nemocnice v Praze; 🇨🇿 Prague, Czechia

Nemocnice Teplice; 🇨🇿 Teplice, Czechia

Krajská nemocnice T. Bati ve Zlíně; 🇨🇿 Zlín, Czechia

Nemocnice České Budějovice; 🇨🇿 České Budějovice, Czechia