Multiple SclerosisNCT05236777
TOPIK Study: A Study to Report Progressive Multifocal Leukoencephalopathy and Other Serious Opportunistic Infections in Natalizumab Treated Participants
An observational study of Multiple Sclerosis, run by Biogen at 15 sites in Czechia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Natalizumab
- How many people
- 675 participants
- Where
- 15 sitesCzechia
- Study dates
- 1 Jan 2019to 30 Apr 2025
- How long will I take part?
- 6 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- Participants starting with natalizumab after 1st January 2019 and participating in the ReMuS will be included in this study
Who cannot join
- Not Applicable (NA)
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Czechia15 sites
Fakultní nemocnice Brno
Brno
Fakultní nemocnice u sv. Anny v Brně
Brno
Nemocnice České Budějovice
České Budějovice
Fakultní nemocnice Hradec Králové
Hradec Králové
Nemocnice Jihlava
Jihlava
Fakultní nemocnice Olomouc
Olomouc
Fakultní nemocnice v Ostravě
Ostrava
Nemocnice Pardubického kraje
Pardubice
Fakultní nemocnice v Plzni
Pilsen
Fakultní nemocnice Královské Vinohrady v Praze
Prague
Fakultní nemocniceMotol v Praze
Prague
Fakultní Thomayerova nemocnice v Praze v Krči
Prague
Všeobecná fakultní nemocnice v Praze
Prague
Nemocnice Teplice
Teplice
Krajská nemocnice T. Bati ve Zlíně
Zlín
About this study
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
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Natalizumab
- Keywords
- Progressive Multifocal Leukoencephalopathy (PML)
- Medical subject headings
- Multiple Sclerosis, Leukoencephalopathy, Progressive Multifocal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NatalizumabDrug
Also called Tysabri
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Natalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Progressive Multifocal Leukoencephalopathy (PML) who are Taking Natalizumab
Measured: Up to 6 years
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.
Measured: Up to 6 years
Secondary outcomes (6)
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.
Measured: Up to 6 years
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.
Measured: Up to 6 years
Number of Participants With Malignancies who are Taking Natalizumab
Measured: Up to 6 years
Number of Participants With Hypersensitivity Reactions who are Taking Natalizumab
Measured: Up to 6 years
Number of Participants who are John Cunningham Virus (JCV) Positive and Taking Natalizumab
Measured: Up to 6 years
Number of Pregnant and Breastfeeding Participants who Were Previously Exposed to Natalizumab
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start1 Jan 2019
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 675 participants (actual)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ReMuS Registry
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236777
- Sponsor's protocol ID
- CZ-TYS-12155
- Status last verified
- May 2025
- First submitted
- 2 Feb 2022
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05236777
- Acronym / sponsor ID
- CZ-TYS-12155
- Conditions
- Multiple Sclerosis
- Keywords
- Progressive Multifocal Leukoencephalopathy (PML)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 675 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Collaborators
- ReMuS Registry
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Natalizumab Cohort | – | Drug: NatalizumabThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Participants starting with natalizumab after 1st January 2019 and participating in the ReMuS will be included in this study
Key exclusion criteria (2 listed)
- Not Applicable (NA)
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NatalizumabAlso: TysabriAdministered as specified in the treatment arm. | Drug | Natalizumab Cohort |
Primary outcome
Number of Participants With Progressive Multifocal Leukoencephalopathy (PML) who are Taking Natalizumab
Time frame: 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.
6 secondary outcomes
Number of Participants With SAEs
Time frame: Up to 6 years
Number of Participants With SAEs Among Participant Subgroups Defined by Demographic and Clinical Factors
Time frame: Up to 6 years
Number of Participants With Malignancies who are Taking Natalizumab
Time frame: Up to 6 years
Number of Participants With Hypersensitivity Reactions who are Taking Natalizumab
Time frame: Up to 6 years
Number of Participants who are John Cunningham Virus (JCV) Positive and Taking Natalizumab
Time frame: Up to 6 years
Number of Pregnant and Breastfeeding Participants who Were Previously Exposed to Natalizumab
Time frame: Up to 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Biogen at 15 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Progressive Multifocal Leukoencephalopathy (PML) who are Taking Natalizumab (time frame: Up to 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.