Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT03002038 |
Date of registration:
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21/12/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Comparison of Clinical Effects of Azathioprine and Rituximab NMO-SD Patients
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Scientific title:
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Comparison of Annual Relapse Rate, Expanded Disability Status Scale, and Side Effects Between Azathioprine and Rituximab in Patients With Neuromyelitis Optica Spectrum Disorders |
Date of first enrolment:
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September 2015 |
Target sample size:
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86 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03002038 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Iran, Islamic Republic of
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Contacts
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Name:
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Vahid Shaygannejad, M.D. |
Address:
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Telephone:
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Email:
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Affiliation:
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Department of Neurology, School of Medicine, Isfahan University of Medical Sciences |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Neuromyelitis Optica Spectrum Disorder
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Intervention(s)
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Drug: Rituximab
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Drug: Azathioprine
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Primary Outcome(s)
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Annual Relapse Rate
[Time Frame: one year]
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Secondary Outcome(s)
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Expanded Disability Status Scale
[Time Frame: one year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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