NCT04256252

Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE)

Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE): a Prospective, Multicenter, Open-label, Follow-up Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

In this research, a prospective, multicenter(Tangdu Hospital of Fourth Military Medical University, Xi'an Gaoxin Hospital of Xi'an Medical College, Xianyang Central Hospital, Baoji Central Hospital, Xi'an Central Hospital, The First Hospital of Xi'an, The Fourth Hospital of Xi'an) open-label, follow-up clinical trial will carry out to evaluate the efficacy and safety of low-dose rituximab in treating NMOSD in Northwest China.

Detailed description

Neuromyelitis optica spectrum disorder (NMOSD) is a group of autoimmune inflammatory demyelinating disease of the central nervous system primarily characterized with recurrent optic neuritis and longitudinally extensive transverse myelitis, leading to blindness and paralysis. Incremental disability due to clinical attacks make it essential to prevent relapses with immunosuppressive therapy. Since the serological pathogenic marker anti-aquaporin 4 immunoglobulin G (anti-AQP4 IgG) has been identified, NMOSD has unveiled its autoimmune features with close connections to B cell-mediated humoral immunity. Rituximab, a chimeric monoclonal antibody directly against human CD20 molecular on the surface of B cells, has been reported to deplete peripheral CD20+ B cells and to be highly effective for treating NMOSD, and therefore been recommended as first-line therapy for this disorder. Unfortunately, there are still no consensus statements on dosing and follow-up regimens, which needs investigations to explore the efficacy and safety of different rituximab strategies. Previous studies have provided pilot evidence supporting the use of low-dose rituximab in preventing relapses in Chinese patients with NMO/NMOSD, however, prospective multicenter studies are still needed to determine the effectiveness of the modified strategy in treating NMOSD.

Conditions

• Neuromyelitis Optica Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Rituximab	A scheduled therapeutic regimen with low-dose rituximab was performed.

Timeline

• Start date: 2014-04-01
• Primary completion: 2020-04-01
• Completion: 2020-06-01
• First posted: 2020-02-05
• Last updated: 2020-10-19