Phase 3
Completed N=86
Comparison of Clinical Effects of Azathioprine and Rituximab NMO-SD Patients
Source: ClinicalTrials.gov NCT03002038 ↗Enrolled (actual)
86
Serious AEs
2.3%
Results posted
Sep 2020
Primary outcomePrimary: Annual Relapse Rate — 1; 1.30; 0.51; 0.21 Number of relapses
◆ Published Evidence
Highly cited
191citations · ~21 / year
Comparison of the efficacy of azathioprine and rituximab in neuromyelitis optica spectrum disorder: a randomized clinical trial.
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.
Linked Publications
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Comparison of the efficacy of azathioprine and rituximab in neuromyelitis optica spectrum disorder: a randomized clinical trial.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT03002038) and the linked publication. 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. Informational only — not medical advice.