Phase 3 N=86 Randomized Treatment

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

Neuromyelitis Optica Spectrum Disorder

Bottom Line

View on ClinicalTrials.gov: NCT03002038 ↗

Enrolled (actual)

Serious AEs

2.3%

Results posted

Sep 2020

Primary outcome: Primary: Annual Relapse Rate — 1; 1.30; 0.51; 0.21 Number of relapses

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Azathioprine (Drug); Rituximab (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Isfahan University of Medical Sciences
Primary completion: Nov 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Annual Relapse Rate	1; 1.30; 0.51; 0.21	—
SECONDARY Expanded Disability Status Scale	2.40; 3.55; 1.95; 2.56	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03002038). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.