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Methylprednisolone During the Switch Between Natalizumab and Fingolimod (NTZ2TTY)

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Methylprednisolone
Placebo
natalizumab (NTZ)
fingolimob (FTY)
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Natalizumab, Fingolimod, Methylprednisolone

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Methylprednisolone

Placebo

Arm Description

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).

Included patients will receive either methylprednisolone (1 gramme, 1 day every 4 weeks for a total of 3 grammes) or undistinguishable capsules of placebo

Outcomes

Primary Outcome Measures

efficacy of high dose methylprednisolone compared to that of a placebo
To evaluate the efficacy of high dose methylprednisolone given once a month during the washout period for the switch between natalizumab and fingolimod, compared to that of a placebo, on multiple sclerosis inflammatory rebound evaluated using MRI, 16 to 18 weeks after natalizumab discontinuation and clinically at 6 months

Secondary Outcome Measures

comparison of the number of new T2 or gadolinium enhanced lesions on MRI in the 2 treatment groups
comparison of the number of MS relapses during the 6 months after natalizumab discontinuation, in the 2 treatment groups
potential correlations between previous MS activity and the risk of relapse or inflammatory rebound on MRI after natalizumab discontinuation
To study the potential correlations between previous MS activity (annualised relapse rate during the year before natalizumab initiation) and the risk of relapse or inflammatory rebound on MRI after natalizumab discontinuation, in the whole group
adverse effects of high dose oral prednisolone
use of methylprednisolone once every 4 weeks during the switch between natalizumab and fingolimod in patients with MS
To perform a cost utility analysis in order to evaluate the use of methylprednisolone once every 4 weeks during the switch between natalizumab and fingolimod in patients with MS

Full Information

First Posted
March 17, 2016
Last Updated
January 5, 2023
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT02769689
Brief Title
Methylprednisolone During the Switch Between Natalizumab and Fingolimod
Acronym
NTZ2TTY
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2019 (Actual)
Primary Completion Date
June 20, 2024 (Anticipated)
Study Completion Date
July 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple sclerosis, Natalizumab, Fingolimod, Methylprednisolone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Methylprednisolone
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Included patients will receive either methylprednisolone (1 gramme, 1 day every 4 weeks for a total of 3 grammes) or undistinguishable capsules of placebo
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
Included patients will receive either methylprednisolone (1 gramme, 1 day every 4 weeks for a total of 3 grammes) or undistinguishable capsules of placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Included patients will receive either methylprednisolone (1 gramme, 1 day every 4 weeks for a total of 3 grammes) or undistinguishable capsules of placebo
Intervention Type
Drug
Intervention Name(s)
natalizumab (NTZ)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
fingolimob (FTY)
Intervention Description
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.
Primary Outcome Measure Information:
Title
efficacy of high dose methylprednisolone compared to that of a placebo
Description
To evaluate the efficacy of high dose methylprednisolone given once a month during the washout period for the switch between natalizumab and fingolimod, compared to that of a placebo, on multiple sclerosis inflammatory rebound evaluated using MRI, 16 to 18 weeks after natalizumab discontinuation and clinically at 6 months
Time Frame
at 6 months
Secondary Outcome Measure Information:
Title
comparison of the number of new T2 or gadolinium enhanced lesions on MRI in the 2 treatment groups
Time Frame
at 4 months
Title
comparison of the number of MS relapses during the 6 months after natalizumab discontinuation, in the 2 treatment groups
Time Frame
at 6 months
Title
potential correlations between previous MS activity and the risk of relapse or inflammatory rebound on MRI after natalizumab discontinuation
Description
To study the potential correlations between previous MS activity (annualised relapse rate during the year before natalizumab initiation) and the risk of relapse or inflammatory rebound on MRI after natalizumab discontinuation, in the whole group
Time Frame
at 6 months
Title
adverse effects of high dose oral prednisolone
Time Frame
at 6 months
Title
use of methylprednisolone once every 4 weeks during the switch between natalizumab and fingolimod in patients with MS
Description
To perform a cost utility analysis in order to evaluate the use of methylprednisolone once every 4 weeks during the switch between natalizumab and fingolimod in patients with MS
Time Frame
at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre CLAVELOU
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Pierre CLAVELOU

12. IPD Sharing Statement

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Methylprednisolone During the Switch Between Natalizumab and Fingolimod

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