Executive Summary : | Guillain Barre syndrome (GBS) is an immune-mediated polyradiculoneuropathy causing acute flaccid paralysis. Treatment options include intravenous immunoglobulin (IVIg) and plasmapheresis (PLEX). However, around 25% of patients still have residual disability and require support for ambulation/ventilation. Recent studies have shown that B cell and complement activation play a central role in GBS-associated neuronal degeneration. Eculizumab, a monoclonal antibody that inhibits C5 complement, has proven beneficial in two randomized controlled trials on GBS. Rituximab, a chimeric monoclonal antibody that binds to CD20 antigens on B cells, decreases downstream B-cell and complement-mediated axonal damage. The RitUximab in Guillain-Barre Syndrome (RUGBY) trial is a prospective, single-center, placebo-controlled, double-blind, randomized phase 3 study conducted at a tertiary care neurology center. GBS patients who are unable to walk independently at presentation and within 2 weeks from symptom onset will be randomized to receive Rituximab (1000mg) or placebo at presentation and at 2 weeks, followed by 20 weeks of follow-up. The primary efficacy outcome will be the proportion of patients who regain independent ambulation (Hughes score ≤ 2) at 4 and 24-weeks post symptom onset. |