NTZ2TTY
We could not find results for this trial
I know where the results areWhat it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Methylprednisolone
Glucocorticoid receptor agonist
- Natalizumab
Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor
- fingolimob (FTY)
Placebo or sham
- Placebo
What it measured
Main measures
efficacy of high dose methylprednisolone compared to that of a placebo
at 6 months
MRI lesions
Other measures (5)
comparison of the number of new T2 or gadolinium enhanced lesions on MRI in the 2 treatment groups
at 4 months
MRI lesionscomparison of the number of MS relapses during the 6 months after natalizumab discontinuation, in the 2 treatment groups
at 6 months
Relapsespotential correlations between previous MS activity and the risk of relapse or inflammatory rebound on MRI after natalizumab discontinuation
at 6 months
RelapsesMRI lesionsadverse effects of high dose oral prednisolone
at 6 months
Safetyuse of methylprednisolone once every 4 weeks during the switch between natalizumab and fingolimod in patients with MS
at 6 months
Who could take part
Relapsing MS · 18 to 65
Inclusion Criteria: * Relapsing-Remitting Multiple Sclerosis (Mc Donald's 2010 criteria) * EDSS\<6.0 * At least18 natalizumab infusions * Planned switch from natalizumab to fingolimod * Aged between 18 and 65 * Patients must have received high dose IV methylprednisolone during the 5 previous years Exclusion Criteria: * Progressive MS * Uncontrolled MS with natalizumab (existence of a relapse during the previous 12 months or existence of a gadolinium enhancing lesion on a MRI performed during the last 12 months) * SEP de forme progressive * Contra-indication to the use of high dose oral methylprednisolone * Marked cognitive impairment altering protocole understanding * Switch from natalizumab to a disease modifying treatment different from fingolimod * Contra-indication to fingolimod use * Existence of a disease or condition that could alter study completion * Chronic treatment with steroids * Acute treatment with steroids (more than 300mg during the month prior to inclusion) * Contra-indication to gadolinium containing products injection * Pregnancy
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Progressive multifocal leukoencephalopathy (PML) is the most feared complication when natalizumab (NTZ) is used in the treatment of relapsing multiple sclerosis (MS). The risk of PML increases after 18 months of treatment. When switching from NTZ to another disease modifying treatment (DMT) in these MS patients with an active disease, there is a high risk of inflammatory reactivation. Nonetheless, a washout period of several weeks is necessary before initiating a new DMT. The primary purpose of this protocol is to investigate the impact of high dose of oral methylprednisolone, given once a month during the washout period between NTZ and Fingolimod (FTY).
Papers
Loading reviews and guidelines…
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History
Started
Jun 2019
Main results due
Jun 2024
Finished
Jul 2024
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