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

Relapsing Remitting Multiple Sclerosis (RRMS) Clinical Trial

Official title: 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)

Status Terminated

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis (RRMS)
• Sclerosis

• NCT number: NCT01499667
• Study type: Interventional
• Source: Novartis
• Status: Terminated
• Phase: Phase 3
• Start date: September 2011
• Completion date: November 2012