NCT03399981Completed
Tysabri Observational Cohort Study - Multiple Sclerosis (MS) Registries
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
Source: ClinicalTrials.gov · Last updated 19 Mar 2024
Brief summary (registry, in English)
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)
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 80327 (actual)
- First submitted
- 9 Jan 2018
- Start date
- 1 Jun 2017
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Biogen
- Diseases
- Multiple sclerosis
- NCT number
- NCT03399981
What you commit to
- Study type: Observational
- Participants enrolled: 80327
- From 1 Jun 2017 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Not applicable
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Site Coordinator of this site? Confirm its status | Cambridge | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.