Clinical Trial: Mycophenolate Mofetil Treatment With Neuromyelitis Optica Spectrum Disorders in Chinese Patients

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Mycophenolate Mofetil Treatment With Neuromyelitis Optica Spectrum Disorders in Chinese Patients

Brief Summary:

Neuromyelitis optica (NMO) is an autoimmune inflammatory demyelinating disease of the central nervous system that leads to blindness and paralysis. Since disability accrues incrementally related to attacks, attack prevention with immunosuppressive therapy is the mainstay of preventing disability. However, there is no standard immunosuppressive treatment strategy for NMO relapse prevention. In a previous study, the investigators provided evidence supporting the use of azathioprine plus a low dose corticosteroid as an effective strategy which is associated with a reduction in the risk of relapse in Chinese patients with NMO, but azathioprine has bone marrow suppression and other side effects. Mycophenolate mofetil (MMF) is a new immunosuppressant with rapid onset, fewer side effects and other advantages. In recent years, MMF has been used in different immune-related neurological diseases; some literature shown the possible efficacy of MMF in NMO treatment.

In this research, a multi-center (Third Affiliated Hospital of Sun Yat-sen University, Zhongshan Ophthalmic Centre of Sun Yat-sen University, Nangfang Hospital of Southern Medical University) study will carry out to evaluate the efficacy and safety of mycophenolate mofetil therapy in NMO spectrum disorders.


Detailed Summary:
Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Current Primary Outcome: Annualized relapse rate day 360 [ Time Frame: day 360 after staring treatment ]

Patients come back for follow-up visit on day 360 after staring treatment, and annualized relapse rate was evaluated.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • expanded disability status scale [ Time Frame: day 1, 14, 30, 90, 180, 270, 360 after staring treatment ]
    Patients come back for follow-up visit on day 1, 14, 30, 90, 180, 270, 360 after staring treatment, and expanded disability status scale was evaluated.
  • Hauser scale [ Time Frame: day 1, 14, 30, 90, 180, 270, 360 after staring treatment ]
    Patients come back for follow-up visit on day 1, 14, 30, 90, 180, 270, 360 after staring treatment, and Hauser scale was evaluated.
  • vision scale [ Time Frame: day 1, 14, 30, 90, 180, 270, 360 after staring treatment ]
    Patients come back for follow-up visit on day 1, 14, 30, 90, 180, 270, 360 after staring treatment, and vision scale was evaluated.
  • Lesions in brain and spinal cord [ Time Frame: day 1, 14, 30, 90, 180, 270, 360 after staring treatment ]
    Patients come back for follow-up visit on day 1, 14, 30, 90, 180, 270, 360 after staring treatment, lesions in brain and spinal cord were evaluated by MRI.
  • Annualized relapse rate [ Time Frame: day 1, 14, 30, 90, 180, 270 after staring treatment ]
    Patients come back for follow-up visit on day 1, 14, 30, 90, 180, 270 after staring treatment, and annualized relapse rate was evaluated.


Original Secondary Outcome: Same as current

Information By: Third Affiliated Hospital, Sun Yat-Sen University

Dates:
Date Received: June 12, 2016
Date Started: January 2016
Date Completion: December 2017
Last Updated: June 19, 2016
Last Verified: June 2016