Neuromyelitis Optica Spectrum Disorder Clinical Trial
Official title:
Comparison of Annual Relapse Rate, Expanded Disability Status Scale, and Side Effects Between Azathioprine and Rituximab in Patients With Neuromyelitis Optica Spectrum Disorders
Verified date | September 2020 |
Source | Isfahan University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 86 |
Est. completion date | December 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Kashani Hospital | Isfahan |
Lead Sponsor | Collaborator |
---|---|
Isfahan University of Medical Sciences |
Iran, Islamic Republic of,
Costanzi C, Matiello M, Lucchinetti CF, Weinshenker BG, Pittock SJ, Mandrekar J, Thapa P, McKeon A. Azathioprine: tolerability, efficacy, and predictors of benefit in neuromyelitis optica. Neurology. 2011 Aug 16;77(7):659-66. doi: 10.1212/WNL.0b013e31822a2780. Epub 2011 Aug 3. — View Citation
Katz Sand I. Neuromyelitis Optica Spectrum Disorders. Continuum (Minneap Minn). 2016 Jun;22(3):864-96. doi: 10.1212/CON.0000000000000337. Review. — View Citation
Kim SH, Huh SY, Lee SJ, Joung A, Kim HJ. A 5-year follow-up of rituximab treatment in patients with neuromyelitis optica spectrum disorder. JAMA Neurol. 2013 Sep 1;70(9):1110-7. — View Citation
Morrow MJ, Wingerchuk D. Neuromyelitis optica. J Neuroophthalmol. 2012 Jun;32(2):154-66. doi: 10.1097/WNO.0b013e31825662f1. Review. — View Citation
Sato DK, Lana-Peixoto MA, Fujihara K, de Seze J. Clinical spectrum and treatment of neuromyelitis optica spectrum disorders: evolution and current status. Brain Pathol. 2013 Nov;23(6):647-60. doi: 10.1111/bpa.12087. Review. — View Citation
Trebst C, Jarius S, Berthele A, Paul F, Schippling S, Wildemann B, Borisow N, Kleiter I, Aktas O, Kümpfel T; Neuromyelitis Optica Study Group (NEMOS). Update on the diagnosis and treatment of neuromyelitis optica: recommendations of the Neuromyelitis Optica Study Group (NEMOS). J Neurol. 2014 Jan;261(1):1-16. doi: 10.1007/s00415-013-7169-7. Epub 2013 Nov 23. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Participants With Adverse Drug Reactions | adverse drug reactions will be observed closely and reported during the intervention. We will compare the number of adverse drug reactions in two groups. Also, adverse drug reactions will be described by details in each group. | one year | |
Primary | Annual Relapse Rate | annual relapse rate will be measured in the baseline (according to patients' history in the last year) and after 12 months of intervention. | one year | |
Secondary | Expanded Disability Status Scale | expanded disability status scale will be measured in the baseline and after 12 months of intervention. Expanded disability status scale (EDSS) is a measure of disability for patients. The score ranges from 0-10, with 0 showing normal neurological exam and 10 showing death due to the disabling disease. Thus, higher scores represent more profound levels of disability. |
one year |
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