Multiple SclerosisPhase 4TYSADIFFNCT02904876
Evaluation of Early Changes Visible to the Diffusion MRI in Response to Two Years of Treatment With Tysabri in Patients With Multiple Sclerosis
A Phase 4 study testing Diffusion Magnetic Resonance Imaging at 6 months in people with Multiple Sclerosis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Through this phase IV study, multicenter prospective exploratory, uncontrolled, the investigators propose to identify MRI predictive factors of treatment response, using diffusion MRI sequences, in addition to conventional sequences. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Diffusion Magnetic Resonance Imaging at 6 months
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to May 2020
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major Patient
- Patient with relapsing remitting multiple sclerosis and eligible for treatment with Tysabri
- Patient affiliated to a social security scheme
- Patient who signed informed consent
- Patient who have been informed of the results of the prior medical examination
Who cannot join
- Patient not currently eligible for treatment with Tysabri
- Contraindication to MRI scanning
- Unability to provide informed consent (subject in an emergency situation, difficulties in understanding , ...)
- Patient under judicial protection
- Patient under guardianship or curatorship
- Pregnancy (women of childbearing age in the absence of effective contraception)
- Breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Through this phase IV study, multicenter prospective exploratory, uncontrolled, the investigators propose to identify MRI predictive factors of treatment response, using diffusion MRI sequences, in addition to conventional sequences.
The primary objective is to study the links between changes on MRI diffusion and response to treatment with Tysabri to 2 years.
The secondary objective is to compare the evolution of diffusion MRI data with the volumetric MRI data.
- Conditions
- Multiple Sclerosis
- Being tested
- Diffusion Magnetic Resonance Imaging at 6 months
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion Magnetic Resonance Imaging at 6 monthsRadiation
2-year follow-up MRI of patients initiating treatment with Tysabri with anti-JCV antibody positive or negative. Patients enrolled will benefit from diffusion MRI at 6 months, in addition to conventional MRI.
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Resonance Imaging at 6 months | Experimental | 2-year follow-up MRI of patients initiating treatment with Tysabri with anti-JCV antibody positive or negative. Patients enrolled will benefit from diffusion MRI at 6 months, in addition to conventional MRI. Receives: Radiation: Diffusion Magnetic Resonance Imaging at 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparaison of diffusion Magnetic Resonance Imaging before and after the initiation of treatment with Tysabri using fractional anisotropy (FA).
Measured: 24 months
Secondary outcomes (1)
Comparison of different Magnetic Resonance Imaging criteria before and after treatment
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startMar 2015
- Primary completionDec 2019
- Study completionMay 2020
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 University Hospital, Strasbourg, FranceThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme DE SEZE, Principal investigator, Service de Neurologie HUS hautepierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904876
- Sponsor's protocol ID
- 5815
- Other IDs
- 2014-003209-14, 2014
- Acronym
- TYSADIFF
- Status last verified
- Aug 2019
- First submitted
- 8 Dec 2014
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Early Changes Visible to the Diffusion MRI in Response to Two Years of Treatment With Tysabri in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02904876
- Acronym / sponsor ID
- TYSADIFF / 5815
- Conditions
- Multiple Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 19 Sep 2016 (estimated)
- 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.
Through this phase IV study, multicenter prospective exploratory, uncontrolled, the investigators propose to identify MRI predictive factors of treatment response, using diffusion MRI sequences, in addition to conventional sequences.
The primary objective is to study the links between changes on MRI diffusion and response to treatment with Tysabri to 2 years.
The secondary objective is to compare the evolution of diffusion MRI data with the volumetric MRI data.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic Resonance Imaging at 6 months | Experimental | Radiation: Diffusion Magnetic Resonance Imaging at 6 months2-year follow-up MRI of patients initiating treatment with Tysabri with anti-JCV antibody positive or negative. Patients enrolled will benefit from diffusion MRI at 6 months, in addition to conventional MRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Major Patient
- Patient with relapsing remitting multiple sclerosis and eligible for treatment with Tysabri
- Patient affiliated to a social security scheme
- Patient who signed informed consent
- Patient who have been informed of the results of the prior medical examination
Key exclusion criteria (7 listed)
- Patient not currently eligible for treatment with Tysabri
- Contraindication to MRI scanning
- Unability to provide informed consent (subject in an emergency situation, difficulties in understanding , ...)
- Patient under judicial protection
- Patient under guardianship or curatorship
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 |
|---|---|---|
| Diffusion Magnetic Resonance Imaging at 6 months2-year follow-up MRI of patients initiating treatment with Tysabri with anti-JCV antibody positive or negative. Patients enrolled will benefit from diffusion MRI at 6 months, in addition to conventional MRI. | Radiation | Magnetic Resonance Imaging at 6 months |
Primary outcome
Comparaison of diffusion Magnetic Resonance Imaging before and after the initiation of treatment with Tysabri using fractional anisotropy (FA).
Time frame: 24 months
1 secondary outcome
Comparison of different Magnetic Resonance Imaging criteria before and after treatment
Time frame: 24 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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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.
Jérôme DE SEZE principal investigator
Service de Neurologie HUS hautepierre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diffusion Magnetic Resonance Imaging at 6 months in people with Multiple Sclerosis, run by University Hospital, Strasbourg, France at 1 site in France.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 16 Mar 2026. 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Comparaison of diffusion Magnetic Resonance Imaging before and after the initiation of treatment with Tysabri using fractional anisotropy (FA). (time frame: 24 months). 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 16 Mar 2026.