Methylprednisolone During the Switch Between Natalizumab and Fingolimod
NCT ID: NCT02769689
Last Updated: 2023-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
56 participants
INTERVENTIONAL
2019-06-12
2024-07-20
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Methylprednisolone
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).
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
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
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.
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
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
Interventions
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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
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
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
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.
Eligibility Criteria
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Inclusion 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Pierre CLAVELOU
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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CHU Clermont-Ferrand
Clermont-Ferrand, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2015-003298-14
Identifier Type: REGISTRY
Identifier Source: secondary_id
CHU-0259
Identifier Type: -
Identifier Source: org_study_id
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