Comparison of Clinical Effects of Azathioprine and Rituximab NMO-SD Patients

Sponsor
Isfahan University of Medical Sciences
Study ID
NCT03002038
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Neuromyelitis Optica Spectrum Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Azathioprine — DRUG
    Patients are started with Azathioprine 50 mg tablets, taken orally twice a day. The medication dose is increased gradually with the aim of lymphocytes count bellow 1500 and to the maximum dose of 3 g Azathioprine per day. Cell blood count is checked once a week in the first month of treatment, once every two weeks in the second month of treatment, and monthly in the third month of treatment to make decision about medication dose.
  • Rituximab — DRUG
    Patients will receive 1 g of Rituximab (two vials of RediTux 500 mg/50 ml) in 500 cc normal saline serum through intravenous infusion and this will be repeated two weeks later. This cycle will be repeated every 6 months.

Study Details

The purpose of this study is to compare annual relapse rate, expanded disability status scale, and side effects of azathioprine and rituximab in patients with neuromyelitis optica spectrum disorder during a one year follow up through a randomized clinical trial.

Key Dates

Start date
Sep 30, 2015
Status verified
Sep 2020
Primary completion
Nov 30, 2016
Completion
Dec 31, 2016

Study Design

Enrollment
86 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Azathioprine
    Patients in this group will receive 50 mg of azathioprine, two times each day and gradually increased to maximum dose of 3 g daily with the aim of lymphocytes count less than 1500.
  • Experimental: Rituximab
    Patients in this group will receive 1g of Rituximab in 500 cc normal saline serum through intravenous infusion with two weeks intervals (as one course) and each course of treatment is repeated every 6 months.

Primary Outcome Measure

Annual Relapse Rate [ Time Frame: one year ]

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