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

June 6, 2023 updated by: Biogen

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
      • Brno, Czechia
        • Recruiting
        • Fakultni nemocnice u sv. Anny v Brne
      • Brno, Czechia
        • Recruiting
        • Fakultni nemocnice Brno
      • Hradec Králové, Czechia
        • Recruiting
        • Fakultni nemocnice Hradec Kralove
      • Jihlava, Czechia
        • Recruiting
        • Nemocnice Jihlava
      • Olomouc, Czechia
        • Recruiting
        • Fakultní Nemocnice Olomouc
      • Ostrava, Czechia
        • Recruiting
        • Fakultní nemocnice v Ostravě
      • Pardubice, Czechia
        • Recruiting
        • Nemocnice Pardubického kraje
      • Pilsen, Czechia
        • Recruiting
        • Fakultní nemocnice v Plzni
      • Prague, Czechia
        • Recruiting
        • Fakultní nemocnice Královské Vinohrady v Praze
      • Prague, Czechia
        • Recruiting
        • Fakultní nemocniceMotol v Praze
      • Prague, Czechia
        • Recruiting
        • Fakultní Thomayerova nemocnice v Praze v Krči
      • Prague, Czechia
        • Recruiting
        • Vseobecna Fakultni Nemocnice V Praze
      • Teplice, Czechia
        • Recruiting
        • Nemocnice Teplice
      • Zlín, Czechia
        • Recruiting
        • Krajská nemocnice T. Bati ve Zlíně
      • České Budějovice, Czechia
        • Recruiting
        • Nemocnice Ceske Budejovice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Administered as specified in the treatment arm.
Other Names:
  • Tysabri

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With SAEs
Time Frame: 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.
Up to 6 years
Number of Participants With SAEs Among Participant Subgroups Defined by Demographic and Clinical Factors
Time Frame: 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.
Up to 6 years
Number of Participants With Malignancies who are Taking Natalizumab
Time Frame: Up to 6 years
Up to 6 years
Number of Participants With Hypersensitivity Reactions who are Taking Natalizumab
Time Frame: Up to 6 years
Up to 6 years
Number of Participants who are John Cunningham Virus (JCV) Positive and Taking Natalizumab
Time Frame: Up to 6 years
Up to 6 years
Number of Pregnant and Breastfeeding Participants who Were Previously Exposed to Natalizumab
Time Frame: Up to 6 years
Up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Collaborators

Association for Functional Rehabilitation, Recreation and Applied Kinesiology Impulse

Investigators

  • Study Director: Medical Director, Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

February 2, 2022

First Submitted That Met QC Criteria

February 2, 2022

First Posted (Actual)

February 11, 2022

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZ-TYS-12155

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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