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RitUximab in Guillain-Barre sYndrome (RUGBY) trial: a single centre, double-blind, randomized phase 3 trial

Implementing Organization

All India Institute of Medical Sciences
Principal Investigator
Dr. Ayush Agarwal
All India Institute of Medical Sciences

Project Overview

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.
Funding Organization
Funding Organization
Science and Engineering Research Board (SERB), New Delhi
Anusandhan National Research Foundation (ANRF)
Quick Information
Area of Research
Medical Sciences
Start Year
2024
End Year
2026
Sanction Amount
₹ 25.74 L
Status
Ongoing
Output
No. of Research Paper
00
Technologies (If Any)
00
No. of PhD Produced
N/A
Startup (If Any)
00
No. of Patents
Filed :00
Grant :00
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