Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to Fingolimod (TOFIINGO)
Relapsing Remitting Multiple Sclerosis (RRMS)
About this trial
This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis (RRMS) focused on measuring Relapsing remitting multiple sclerosis, multiple sclerosis (MS), safety, tolerability, health outcomes, fingolimod, disease control, MRI
Eligibility Criteria
Inclusion Criteria:
Patients must:
- Have relapsing remitting multiple sclerosis
- Have been on treatment with natalizumab for at least 6 months prior to screening and discontinuation is an option.
Exclusion Criteria:
Patients with:
- History of chronic immune disease
- Crohn's disease
- Certain cancers
- Uncontrolled diabetes
- Certain eye disorders
- Negative for varicella-zoster virus IgG antibodies
- Certain hepatic conditions
- Low white blood cell count
- On certain immunosuppressive medications or heart medications
- Resting heart rate less than 45 bpm.
- Certain heart conditions or certain lung conditions
- Inability to undergo MRI scans
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Novartis Investigative Site
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- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
8-week washout + Fingolimod (FTY720)
12-week washout + Fingolimod (FTY720)
16-week washout + Fingolimod (FTY720)
8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day