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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05236777
• Other study ID #: CZ-TYS-12155
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: April 30, 2025

Study information

• Verified date: June 2023
• Source: Biogen
• Contact: US Biogen Clinical Trial Center
• Phone: 866-633-4636
• Email: clinicaltrials[@]biogen.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Key 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.

Related Conditions & MeSH terms

• Leukoencephalopathies
• Leukoencephalopathy, Progressive Multifocal
• Multiple Sclerosis
• Opportunistic Infections
• Sclerosis

Intervention

Drug:
• Natalizumab
Administered as specified in the treatment arm.

Locations

Country	Name	City	State
Czechia	Fakultní nemocnice Brno	Brno
Czechia	Fakultní nemocnice u sv. Anny v Brne	Brno
Czechia	Nemocnice Ceské Budejovice	Ceské Budejovice
Czechia	Fakultní nemocnice Hradec Králové	Hradec Králové
Czechia	Nemocnice Jihlava	Jihlava
Czechia	Fakultní nemocnice Olomouc	Olomouc
Czechia	Fakultní nemocnice v Ostrave	Ostrava
Czechia	Nemocnice Pardubického kraje	Pardubice
Czechia	Fakultní nemocnice v Plzni	Pilsen
Czechia	Fakultní nemocnice Královské Vinohrady v Praze	Prague
Czechia	Fakultní nemocniceMotol v Praze	Prague
Czechia	Fakultní Thomayerova nemocnice v Praze v Krci	Prague
Czechia	Všeobecná fakultní nemocnice v Praze	Prague
Czechia	Nemocnice Teplice	Teplice
Czechia	Krajská nemocnice T. Bati ve Zlíne	Zlín

Sponsors (2)

Lead Sponsor	Collaborator
Biogen	Association for Functional Rehabilitation, Recreation and Applied Kinesiology Impulse

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Progressive Multifocal Leukoencephalopathy (PML) who are Taking Natalizumab		Up to 6 years
Primary	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	Number of Participants With SAEs	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.	Up to 6 years
Secondary	Number of Participants With SAEs Among Participant Subgroups Defined by Demographic and Clinical Factors	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.	Up to 6 years
Secondary	Number of Participants With Malignancies who are Taking Natalizumab		Up to 6 years
Secondary	Number of Participants With Hypersensitivity Reactions who are Taking Natalizumab		Up to 6 years
Secondary	Number of Participants who are John Cunningham Virus (JCV) Positive and Taking Natalizumab		Up to 6 years
Secondary	Number of Pregnant and Breastfeeding Participants who Were Previously Exposed to Natalizumab		Up to 6 years