Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to Fingolimod

A 32-week, Patient- and Rater-blinded, Randomized, Multi-center, Parallel-group Study to Evaluate Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis Transferred From Previous Treatment With Natalizumab to Fingolimod (FTY720)

This study evaluated disease control during different lengths of treatment transition from natalizumab to fingolimod.

Patient were screened, signed an informed consent at visit 1, at the 2nd visit, all patient received a baseline infusion of Natalizumub and subsequently randomized to one of 3 treatment arms. At the randomization visit, the Washout Phase started, and eligible patients were randomized 1:1:1 to one of three treatment groups:

• 8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod,
• 12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod, or
• 16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod.

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