Clinical trial NCT05236777: TOPIK Study: A Study to Report Progressive Multifocal Leukoencephalopathy and Other Serious Opportunistic Infections in Natalizumab Treated Participants
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Progressive Multifocal Leukoencephalopathy (PML)
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: ReMuS Registry
First posted: 2022-02-11
Enrollment: 675
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Progressive Multifocal Leukoencephalopathy (PML) who are Taking Natalizumab
timeFrame: Up to 6 years
measure: Number of Participants with Serious Adverse Events (SAEs) of Other Opportunistic Infections (OIs) who are Taking Natalizumab
timeFrame: Up to 6 years
Secondary outcomes:
measure: Number of Participants With SAEs
timeFrame: Up to 6 years
measure: Number of Participants With SAEs Among Participant Subgroups Defined by Demographic and Clinical Factors
timeFrame: Up to 6 years
measure: Number of Participants With Malignancies who are Taking Natalizumab
timeFrame: Up to 6 years
measure: Number of Participants With Hypersensitivity Reactions who are Taking Natalizumab
timeFrame: Up to 6 years
measure: Number of Participants who are John Cunningham Virus (JCV) Positive and Taking Natalizumab
timeFrame: Up to 6 years
measure: Number of Pregnant and Breastfeeding Participants who Were Previously Exposed to Natalizumab
timeFrame: Up to 6 years
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Fakultní nemocnice Brno
city: Brno
country: Czechia
facility: Fakultní nemocnice u sv. Anny v Brně
city: Hradec Králové
country: Czechia
facility: Fakultní nemocnice Hradec Králové
city: Jihlava
country: Czechia
facility: Nemocnice Jihlava
city: Olomouc
country: Czechia
facility: Fakultní nemocnice Olomouc
city: Ostrava
country: Czechia
facility: Fakultní nemocnice v Ostravě
city: Pardubice
country: Czechia
facility: Nemocnice Pardubického kraje
city: Pilsen
country: Czechia
facility: Fakultní nemocnice v Plzni
city: Prague
country: Czechia
facility: Fakultní nemocnice Královské Vinohrady v Praze
city: Prague
country: Czechia
facility: Fakultní nemocniceMotol v Praze
city: Prague
country: Czechia
facility: Fakultní Thomayerova nemocnice v Praze v Krči
city: Prague
country: Czechia
facility: Všeobecná fakultní nemocnice v Praze
city: Teplice
country: Czechia
facility: Nemocnice Teplice
city: Zlín
country: Czechia
facility: Krajská nemocnice T. Bati ve Zlíně
city: České Budějovice
country: Czechia
facility: Nemocnice České Budějovice
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: