Progressive Multifocal LeukoencephalopathyNCT03399981
Tysabri Observational Cohort Study - Multiple Sclerosis (MS) Registries
An observational study of Progressive Multifocal Leukoencephalopathy, run by Biogen at 1 site in United States.
Trial summary
The primary purpose of this study is to estimate the incidence of progressive multifocal leukoencephalopathy (PML) among patients who switched to Tysabri from disease modifying therapies (DMTs), including newer DMTs (including fingolimod, dimethyl fumarate and teriflunomide) and the established DMTs (interferon beta… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Progressive Multifocal Leukoencephalopathy
- What is being tested?
- Tysabri
- How many people
- 80,327 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 31 Dec 2023
- 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: All TOUCH and available EU MS registry participants who have switched from DMTs (including fingolimod, dimethyl fumarate, teriflunomide, interferon beta and glatiramer acetate) and have one or more infusion(s) of Tysabri.
Who may be able to join
- All TOUCH and available EU MS registry participants who have switched from DMTs (including fingolimod, dimethyl fumarate, teriflunomide, interferon beta and glatiramer acetate) and have one or more infusion(s) of Tysabri.
Who cannot join
- Not applicable
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study Utilising Data From the US Tysabri TOUCH Programme and Select EU MS Registries to Estimate the Risk of Progressive Multifocal Leukoencephalopathy (PML) and Other Serious Opportunistic Infections Among Patients Who Were Exposed to an MS Disease Modifying Treatment Prior to Treatment With Tysabri
The primary purpose of this study is to estimate the incidence of progressive multifocal leukoencephalopathy (PML) among patients who switched to Tysabri from disease modifying therapies (DMTs), including newer DMTs (including fingolimod, dimethyl fumarate and teriflunomide) and the established DMTs (interferon beta and glatiramer acetate). Researchers will also look to estimate the incidence of other serious opportunistic infections among patients who switch to Tysabri from newer DMTs (including fingolimod, dimethyl fumarate and teriflunomide) and the established DMTs (interferon beta and glatiramer acetate)
Read the detailed description
This is an observational cohort study utilising all available data from the Tysabri TOUCH (TYSABRI Outreach: Unified Commitment to Health) prescribing programme (US) supplemented with data from European Union (EU) multiple sclerosis (MS) registries to estimate the risk of PML and other serious opportunistic infections (OIs) among patients on Tysabri who have switched from newer DMTs (including fingolimod, dimethyl fumarate and teriflunomide) and the established DMTs (interferon beta and glatiramer acetate).
This study will provide cumulative data from its two components: a retrospective component (data captured prior to 01 January 2016) and a prospective component (data captured, and patients followed up, from 01 January 2016 through 31 December 2023; total prospective study duration of 8 years). All patients who switched to Tysabri from another DMT through 31 December 2020 will be included. The study will continue to follow-up patients until 31 December 2023 to allow for a minimal follow-up of 3 years.
- Being tested
- Tysabri
- Medical subject headings
- Leukoencephalopathy, Progressive Multifocal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TysabriBiological
Also called Natalizumab BG00002
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Tysabri (TOUCH Cohort) | Participants from the Tysabri TOUCH prescribing programme who have switched to Tysabri from newer DMTs (including fingolimod, dimethyl fumarate and teriflunomide) and the established DMTs (interferon beta and glatiramer acetate). Receives: Biological: Tysabri | |
| Tysabri (EU MS Cohort) | Participants from the EU MS registry who have switched to Tysabri from newer DMTs (including fingolimod, dimethyl fumarate and teriflunomide) and the established DMTs (interferon beta and glatiramer acetate). Receives: Biological: Tysabri |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prospective and Retrospective Analyses: Number of Participants with Confirmed Progressive Multifocal Leukoencephalopathy (PML)
Confirmed cases of PML must have one of the following:
- Brain biopsy or brain from post mortem examination showing evidence of viral cytopathic changes on hematoxylin and eosin (H \& E) staining associated with either positive immunohistochemistry for SV40 or in-situ hybridization for John Cunningham Virus (JCV) deoxyribonucleic acid (DNA) OR
All of the following criteria:
- Cerebrospinal fluid (CSF) with evidence of JCV DNA, preferably by ultra-sensitive quantitative polymerase chain reaction (PCR) testing (limit of quantification of ≤ 50 copies/ml), or JCV DNA on brain biopsy by PCR AND detailed description of brain magnetic resonance imaging (MRI) findings that are consistent with PML AND PREFERABLY new or progressive clinical symptoms suggestive of PML
Measured: Retrospective: from the time of switching to Tysabri to 31 December 2015; Prospective: from the time of switching to Tysabri (on or after 01 January 2016) to 31 December 2023 (up to 8 years)
Prospective and Retrospective Analyses: Number of Participants with Serious Adverse Events of Other Serious Opportunistic Infections (OIs)
An SAE is any untoward medical occurrence at any dose that results in death, immediate risk of death, hospitalization, disability, or congenital anomaly/birth defect.
Opportunistic infections (OIs) are infections that occur more frequently and are more severe in individuals with weakened immune systems.
Measured: Retrospective: from the time of switching to Tysabri to 31 December 2015; Prospective: from the time of switching to Tysabri (on or after 01 January 2016) to 31 December 2023 (up to 8 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start1 Jun 2017
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Multifocal LeukoencephalopathyStudies 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
- Other
- Enrolment
- 80,327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399981
- Sponsor's protocol ID
- 101MS411
- Other IDs
- EUPAS19800
- Status last verified
- Mar 2024
- First submitted
- 9 Jan 2018
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study Utilising Data From the US Tysabri TOUCH Programme and Select EU MS Registries to Estimate the Risk of Progressive Multifocal Leukoencephalopathy (PML) and Other Serious Opportunistic Infections Among Patients Who Were Exposed to an MS Disease Modifying Treatment Prior to Treatment With Tysabri
- ClinicalTrials.gov ID
- NCT03399981
- Acronym / sponsor ID
- 101MS411
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80,327 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 17 Jan 2018 (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 purpose of this study is to estimate the incidence of progressive multifocal leukoencephalopathy (PML) among patients who switched to Tysabri from disease modifying therapies (DMTs), including newer DMTs (including fingolimod, dimethyl fumarate and teriflunomide) and the established DMTs (interferon beta and glatiramer acetate). Researchers will also look to estimate the incidence of other serious opportunistic infections among patients who switch to Tysabri from newer DMTs (including fingolimod, dimethyl fumarate and teriflunomide) and the established DMTs (interferon beta and glatiramer acetate)
Detailed description
This is an observational cohort study utilising all available data from the Tysabri TOUCH (TYSABRI Outreach: Unified Commitment to Health) prescribing programme (US) supplemented with data from European Union (EU) multiple sclerosis (MS) registries to estimate the risk of PML and other serious opportunistic infections (OIs) among patients on Tysabri who have switched from newer DMTs (including fingolimod, dimethyl fumarate and teriflunomide) and the established DMTs (interferon beta and glatiramer acetate).
This study will provide cumulative data from its two components: a retrospective component (data captured prior to 01 January 2016) and a prospective component (data captured, and patients followed up, from 01 January 2016 through 31 December 2023; total prospective study duration of 8 years). All patients who switched to Tysabri from another DMT through 31 December 2020 will be included. The study will continue to follow-up patients until 31 December 2023 to allow for a minimal follow-up of 3 years.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tysabri (TOUCH Cohort) | – | Biological: TysabriParticipants from the Tysabri TOUCH prescribing programme who have switched to Tysabri from newer DMTs (including fingolimod, dimethyl fumarate and teriflunomide) and the established DMTs (interferon beta and glatiramer acetate). |
| Tysabri (EU MS Cohort) | – | Biological: TysabriParticipants from the EU MS registry who have switched to Tysabri from newer DMTs (including fingolimod, dimethyl fumarate and teriflunomide) and the established DMTs (interferon beta and glatiramer acetate). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All TOUCH and available EU MS registry participants who have switched from DMTs (including fingolimod, dimethyl fumarate, teriflunomide, interferon beta and glatiramer acetate) and have one or more infusion(s) of Tysabri.
Key inclusion criteria (1 listed)
- All TOUCH and available EU MS registry participants who have switched from DMTs (including fingolimod, dimethyl fumarate, teriflunomide, interferon beta and glatiramer acetate) and have one or more infusion(s) of Tysabri.
Key exclusion criteria (2 listed)
- Not applicable
- 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 |
|---|---|---|
| TysabriAlso: Natalizumab BG00002Administered as specified in the treatment arm. | Biological | Tysabri (EU MS Cohort), Tysabri (TOUCH Cohort) |
Primary outcome
Prospective and Retrospective Analyses: Number of Participants with Confirmed Progressive Multifocal Leukoencephalopathy (PML)
Time frame: Retrospective: from the time of switching to Tysabri to 31 December 2015; Prospective: from the time of switching to Tysabri (on or after 01 January 2016) to 31 December 2023 (up to 8 years)
Confirmed cases of PML must have one of the following: • Brain biopsy or brain from post mortem examination showing evidence of viral cytopathic changes on hematoxylin and eosin (H \& E) staining associated with either positive immunohistochemistry for SV40 or in-situ hybridization for John Cunningham Virus (JCV) deoxyribonucleic acid (DNA) OR All of the following criteria: • Cerebrospinal fluid (CSF) with evidence of JCV DNA, preferably by ultra-sensitive quantitative polymerase chain reaction (PCR) testing (limit of quantification of ≤ 50 copies/ml), or JCV DNA on brain biopsy by PCR AND detailed description of brain magnetic resonance imaging (MRI) findings that are consistent with PML AND PREFERABLY new or progressive clinical symptoms suggestive of PML
Prospective and Retrospective Analyses: Number of Participants with Serious Adverse Events of Other Serious Opportunistic Infections (OIs)
Time frame: Retrospective: from the time of switching to Tysabri to 31 December 2015; Prospective: from the time of switching to Tysabri (on or after 01 January 2016) to 31 December 2023 (up to 8 years)
An SAE is any untoward medical occurrence at any dose that results in death, immediate risk of death, hospitalization, disability, or congenital anomaly/birth defect. Opportunistic infections (OIs) are infections that occur more frequently and are more severe in individuals with weakened immune systems.
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 19 Mar 2024.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Progressive Multifocal Leukoencephalopathy, run by Biogen at 1 site in United States.
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 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Prospective and Retrospective Analyses: Number of Participants with Confirmed Progressive Multifocal Leukoencephalopathy (PML) (time frame: Retrospective: from the time of switching to Tysabri to 31 December 2015; Prospective: from the time of switching to Tysabri (on or after 01 January 2016) to 31 December 2023 (up to 8 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 19 Mar 2024.