Informations générales (source: ClinicalTrials.gov)

NCT02769689 Statut inconnu
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) (NTZ2TTY)
Interventional
  • Sclérose en plaques
  • Sclérose
Phase 4
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
juin 2019
juillet 2024
03 août 2024
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).
 Voir le détail

Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU Clermont-Ferrand - 63003 - Clermont-Ferrand - France Patrick LACARIN En recrutement Contact (sur clinicalTrials)

Critères

Tous
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


- 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