Study to Assess Immune Function and MRI Disease Activity in RRMS Patients When Switching From Natalizumab to Gilenya — ToFingo2  

Relapsing Remitting Multiple Sclerosis Clinical Trial

Official title: A 32-week, Monocentric, Exploratory, Single Arm Study to Assess Immune Function and MRI Disease Activity in Patients With RRMS Transferred From Previous Treatment With Natalizumab to Gilenya® (Fingolimod)

Status Recruiting

Clinical Trial Summary

A trial in patients with relapsing remitting multiple sclerosis (RRMS)

Main objectives:

• To evaluate changes in the reconstitution of immune surveillance over time upon switching from natalizumab to fingolimod assessed by a change in the expression of CD49d.

• To evaluate changes in the migratory capacity of immune cells/peripheral blood mononuclear cells (PBMCs) upon switching from natalizumab to fingolimod in an in-vitro model of the blood-brain-barrier (BBB).

• To evaluate changes in paraclinical disease activity over time upon switching from natalizumab to fingolimod assessed by MRI (changes in Gd+, T2w lesions and DTI).

• To evaluate changes in T1w / FLAIR lesions upon switching from natalizumab to fingolimod.

Clinical Trial Description

Patients are screened and must sign informed consent at visit 1. At the 2nd visit, all patients receive a baseline infusion of Natalizumab, which is followed by an 8 week washout Phase. After the washout Phase all patients receive fingolimod for 32 weeks. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis

• NCT number: NCT02325440
• Study type: Interventional
• Source: University Hospital Muenster
• Contact: Luisa Klotz, PD Dr. med.
• Phone: +49 251 98029
• Email: luisa.klotz@ukmuenster.de
• Status: Recruiting
• Phase: Phase 4
• Start date: March 2014
• Completion date: April 2016