Status unknownPhase 4Relapsing MSNCT02769689

We could not find results for this trial

I know where the results are

What it found

No result 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 lesions
  • comparison of the number of MS relapses during the 6 months after natalizumab discontinuation, in the 2 treatment groups

    at 6 months

    Relapses
  • potential correlations between previous MS activity and the risk of relapse or inflammatory rebound on MRI after natalizumab discontinuation

    at 6 months

    RelapsesMRI lesions
  • adverse effects of high dose oral prednisolone

    at 6 months

    Safety
  • use 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…

    Related trials

    History

      1. Started

        Jun 2019

      2. Main results due

        Jun 2024

      3. Finished

        Jul 2024

      Assembled by software from public sources and not checked by people. Each record links to its source. Report an error