Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 61 of 10804 for:    Placebo AND once

Methylprednisolone During the Switch Between Natalizumab and Fingolimod (NTZ2TTY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02769689
Recruitment Status : Unknown
Verified May 2016 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : May 12, 2016
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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).


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Methylprednisolone Drug: Placebo Drug: natalizumab (NTZ) Drug: fingolimob (FTY) Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : April 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : November 2017


Arm Intervention/treatment
Experimental: 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).
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: 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.

Placebo Comparator: 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: 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




Primary Outcome Measures :
  1. efficacy of high dose methylprednisolone compared to that of a placebo [ Time Frame: at 6 months ]
    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 :
  1. comparison of the number of new T2 or gadolinium enhanced lesions on MRI in the 2 treatment groups [ Time Frame: at 4 months ]
  2. comparison of the number of MS relapses during the 6 months after natalizumab discontinuation, in the 2 treatment groups [ Time Frame: at 6 months ]
  3. potential correlations between previous MS activity and the risk of relapse or inflammatory rebound on MRI after natalizumab discontinuation [ Time Frame: at 6 months ]
    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

  4. adverse effects of high dose oral prednisolone [ Time Frame: at 6 months ]
  5. use of methylprednisolone once every 4 weeks during the switch between natalizumab and fingolimod in patients with MS [ Time Frame: at 6 months ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02769689


Contacts
Layout table for location contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
Layout table for location information
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Pierre CLAVELOU         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Layout table for investigator information
Principal Investigator: Pierre CLAVELOU University Hospital, Clermont-Ferrand

Layout table for additonal information
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02769689     History of Changes
Other Study ID Numbers: CHU-0259
2015-003298-14 ( Registry Identifier: 2015-003298-14 )
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by University Hospital, Clermont-Ferrand:
Multiple sclerosis
Natalizumab
Fingolimod
Methylprednisolone

Additional relevant MeSH terms:
Layout table for MeSH terms
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Natalizumab
Fingolimod Hydrochloride
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal