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Once a Month High-dose Methylprednisolone During Wash-out Period Between Natalizumab and Fingolimod Treatments in Patients With Multiple Sclerosis: a Randomised, Controlled, Double-blind Trial (NTZ2FTY) (NCT02769689)

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).
  • Drug: Methylprednisolone
    Included patients will receive either methylprednisolone (1 gramme, 1 day every 4 weeks for a total of 3 grammes) or undistinguishable capsules of placebo
    • Drug: Placebo
      Included patients will receive either methylprednisolone (1 gramme, 1 day every 4 weeks for a total of 3 grammes) or undistinguishable capsules of placebo
      • Drug: natalizumab (NTZ)
        Patients with MS receiving NTZ for at least 18 months and without any disease activity during the previous year will be eligible. Included patients will receive either methylprednisolone (1 gramme, 1 day every 4 weeks for a total of 3 grammes) or undistinguishable capsules of placebo
        • Drug: fingolimob (FTY)
          Every patient will initiate a treatment with FTY 7 weeks after the last NTZ perfusion. Methylprednisolone or placebo will be taken 4, 8 and 12 weeks (W4, W8 and W12) after NTZ discontinuation.
          Ages eligible for Study
          18 Years to 65 Years
          Genders eligible for Study
          All
          Accepts Healthy Volunteers
          No
          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
          Patients with MS receiving NTZ for at least 18 months and without any disease activity during the previous year will be eligible. Included patients will receive either methylprednisolone (1 gramme, 1 day every 4 weeks for a total of 3 grammes) or undistinguishable capsules of placebo.

          Every patient will initiate a treatment with FTY 7 weeks after the last NTZ perfusion. Methylprednisolone or placebo will be taken 4, 8 and 12 weeks (W4, W8 and W12) after NTZ discontinuation.

          A spinal and brain MRI will be performed at baseline (last NTZ perfusion, noted W0) and 16 to 18 weeks after. The last clinical follow-up will be made after 24 weeks.

          1 locations

          France (1)
          • CHU Clermont-Ferrand
            recruiting
            Clermont-Ferrand, France, 63003
          Status:
          unknown
          Type:
          Interventional
          Phase:
          Start:
          31 March, 2016
          Updated:
          08 May, 2016
          Participants:
          56
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