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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03002038
• Date of registration: 21/12/2016
• Prospective Registration: No
• Primary sponsor: Isfahan University of Medical Sciences
• Public title: Comparison of Clinical Effects of Azathioprine and Rituximab NMO-SD Patients
• Scientific title: 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: September 2015
• Target sample size: 86
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03002038
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2/Phase 3

Countries of recruitment

Iran, Islamic Republic of

Contacts

• Name: Vahid Shaygannejad, M.D.
• Affiliation: Department of Neurology, School of Medicine, Isfahan University of Medical Sciences

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Neuromyelitis Optica Spectrum Disorder

Intervention(s)

Drug: Azathioprine

Drug: Rituximab

Primary Outcome(s)

Annual Relapse Rate [Time Frame: one year]

Secondary Outcome(s)

Expanded Disability Status Scale [Time Frame: one year]

Secondary ID(s)

395275

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/09/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03002038