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

Sponsor
Tang-Du Hospital
Study ID
NCT04256252
Phase
PHASE4
Status
Completed

Conditions

  • Neuromyelitis Optica Spectrum Disorder

Eligibility Criteria

Sex
ALL
Age
16 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    A scheduled therapeutic regimen with low-dose rituximab was performed.

Study Details

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.

Key Dates

Start date
Apr 30, 2014
Status verified
Oct 2020
Primary completion
Apr 30, 2020
Completion
Jun 30, 2020

Study Design

Enrollment
108 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab
    Intravenous rituximab was administered at a fixed dose of 100 mg once weekly for 3 weeks, followed by maintenance treatment with 100 mg rituximab every 6 months.

Primary Outcome Measure

Annualized relapse rate at last follow-up visit [ Time Frame: 12 months ]

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