Proposed T2T NEDA Trial

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Proposed T2T NEDA Trial

  1. 1. PROPOSED NEDA Rx Trial Relapsing-remitting MS (RRMS) NEDA = No Evident of Disease Activity T2T = treat-2-target RES = rapidly evolving severe MS HAD = highly-active disease activity Active disease? N Observation Y RES disease? Y Rx with Nz N Randomise Current practice Current 1st-line treatments IFNb, GA (Teri, BG12) Current 1st-line treatments IFNb, GA (Teri, BG12) 6-monthly* clinical F-UP Switch in lower tier IFNb, GA (Teri, BG12) T2T-NEDA 6-monthly* clinical/MRI F-UP Y Clinical responder? Y Clinical/MRI responder? N N HAD or RES? N Escalation/switch in upper tier natalizumab, fingolimod (Alemz) Y Escalation/switch to upper tier natalizumab, fingolimod (Alemz) 3-yr 1° outcome: confirmed disability progression 5-yr 1° outcome: time to confirmed EDSS 4.0 2° outcomes: MRI etc. * A clinical relapse between 6-monthly visits will trigger an unscheduled assessment for switching/escalation GG, version 1.0 3rd Jan 2014

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