Overview

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

Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Isfahan University of Medical Sciences
Treatments:
Azathioprine
Rituximab
Criteria
Inclusion Criteria:

- Diagnosis of neuromyelitis optica spectrum disorder based on the recent guidelines in
2015

- Expanded disability status scale between 0 and 7

- Age between 18 and 50 years old

Exclusion Criteria:

- Pregnancy or lactation during the study

- Deciding to leave the study by patient

- Lack of consent to enter the study

- Lack of cooperation for follow up

- Severe side effect of the medication

- Treatment with other immunosuppressant medications (including but not limited to
cyclophosphamide, mycophenolate mofetil, methotrexate, others) within two months
before intervention

- Taking any other immunosuppressant or other type of medication (including herbal
drugs) without permission of the physician during the study.

- Presence of other autoimmune disease (including but not limited to Behcet disease,
systemic lupus erythematosus, rheumatoid arthritis, and others)

- Presence of liver disorders

- Presence of hematologic disorders

- Presence of heart failure

- Receipt of a live vaccine within 4 weeks prior to intervention

- Previous treatment with Azathioporine or Rituximab

- History of HIV, hepatitis B, or hepatitis C

- Ongoing daily steroid use

- History of severe allergic or anaphylactic reaction to monoclonal antibodies