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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

November 30, 2016

Study Completion Date

December 31, 2016

Conditions
Neuromyelitis Optica Spectrum Disorder
Interventions
DRUG

Azathioprine

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.

DRUG

Rituximab

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.

Trial Locations (1)

8174673461

Kashani Hospital, Isfahan

All Listed Sponsors
lead

Isfahan University of Medical Sciences

OTHER

NCT03002038 - Comparison of Clinical Effects of Azathioprine and Rituximab NMO-SD Patients | Biotech Hunter | Biotech Hunter