Clinical Trials Logo

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.


Clinical Trial Description

Neuromyelitis Optica Spectrum Disorder (NMO-SD) is a recurrent inflammatory demyelinating disease affecting the central nervous system. The disease is clinically recognized by optic neuritis and transverse myelitis and is associated with high risk of mortality. Each attack worsens patients' disability. This means that after 5 years of the disease onset, half of patients need to use wheelchair and approximately 50% of them become blind.

Considering that the disease can be disabling for patients, the maintenance treatment should be applied in addition to treatment of acute attacks, in order to prevent future recurrences. Acute attacks are usually treated with high doses of intravenous corticosteroids. Plasmapheresis is also used when patients fail to response to corticosteroids. B lymphocyte inhibitors are used as the maintenance therapy in these patients. First line therapeutic medications include azathioprine and rituximab which are being recommended for long term therapy and second line medications include methotrexate and mycophenolate mofetil.

Azathioprine is an immune-modulatory agent which is available in the oral form and don't require hospitalization to be administered, however, because of side effects such as bone marrow suppression and hepatotoxicity, periodic check of blood cells and liver enzymes are needed. Rituximab is a cluster of differentiation antigen 20 inhibitor which leads to decreased B lymphocytes and antibody in patients. This medication is only available in the injectable form and needs hospitalization to be administered. Close monitory is needed during the administration considering severe side effects such as allergic reactions and respiratory distress. However, laboratory tests are not needed in patients taking rituximab although it is more expensive than azathioprine. No clinical trial has been performed previously to compare clinical efficacy of these two drugs in NMO-SD patients. Therefore, we aimed to compare their efficacy through a randomized clinical trial. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03002038
Study type Interventional
Source Isfahan University of Medical Sciences
Contact
Status Completed
Phase Phase 2/Phase 3
Start date September 2015
Completion date December 2016

See also
  Status Clinical Trial Phase
Recruiting NCT04561557 - Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous System Early Phase 1
Not yet recruiting NCT04064944 - Comparison of the Efficacy and Safety of Immunoadsorption and Plasma Exchange for Acute Attack of Refractory Neuromyelitis Optica Spectrum Disorders Phase 2
Recruiting NCT05414487 - Effects of Ofatumumab Treatment on Immune Cells and Meningeal Lymphatic Drainage in Patients With Demyelinating Diseases
Not yet recruiting NCT05551598 - Efficacy and Safety of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) Phase 2
Recruiting NCT05403138 - Safety and Efficacy of Daratumumab in Patients With Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorders Phase 2/Phase 3
Completed NCT01845584 - Phase II Clinical Trial of NPB-01 in Patients With Anti-aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder Not Provided Adequate Effect of Therapy to Steroids Plus Therapy. Phase 2
Completed NCT04660539 - A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD) Phase 3
Recruiting NCT05199688 - A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD) Phase 3
Recruiting NCT05504694 - Ofatumumab in AQP4-IgG Seropositive NMOSD Phase 1/Phase 2
Recruiting NCT05346354 - Efficacy and Safety Study of Ravulizumab IV in Pediatric Participants With NMOSD Phase 2/Phase 3
Completed NCT01777412 - Efficacy of Bevacizumab (Avastin) in Treatment of Acute NMO Exacerbations Phase 1
Recruiting NCT01623076 - The Longitudinal CONQUER Study of Rare Neuroimmunologic Disorders
Completed NCT01500681 - Maintenance Plasma Exchange for Neuromyelitis Optica
Not yet recruiting NCT06374264 - Acceptability and Safety of MR-C-014 in Persons With Neuromyelitis Optica Spectrum Disorder N/A
Not yet recruiting NCT05891379 - Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders
Recruiting NCT05909761 - Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
Completed NCT02276963 - Ublituximab for Acute Neuromyelitis Optica (NMO) Relapses Phase 1
Terminated NCT04155424 - A Study of the Safety and Activity of Eculizumab in Pediatric Participants With Relapsing Neuromyelitis Optica Spectrum Disorder Phase 2/Phase 3
Completed NCT02003144 - An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients Phase 3
Completed NCT03819413 - Clinical Patterns of Neuromyelitis Optica Spectrum Disorders in Assiut University Hospital