Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 40 of 1164 for:    MYCOPHENOLIC ACID

Mycophenolate Mofetil Treatment With Neuromyelitis Optica Spectrum Disorders in Chinese Patients (MONICA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02809079
Recruitment Status : Unknown
Verified June 2016 by Wei Qiu, Third Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Enrolling by invitation
First Posted : June 22, 2016
Last Update Posted : June 22, 2016
Sponsor:
Collaborators:
Zhongshan Ophthalmic Center, Sun Yat-sen University
Southern Medical University, China
Information provided by (Responsible Party):
Wei Qiu, Third Affiliated Hospital, Sun Yat-Sen University

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.


Condition or disease Intervention/treatment Phase
Neuromyelitis Optica Spectrum Disorders Mycophenolate Mofetil Efficacy and Safety Drug: Mycophenolate mofetil Drug: Prednisone Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mycophenolate Mofetil Treatment With Neuromyelitis Optica Spectrum Disorders in Chinese Patients
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: Mycophenolate mofetil plus prednisone
Mycophenolate mofetil 500mg Bid and prednisone 10mg Qd
Drug: Mycophenolate mofetil
Mycophenolate mofetil 500mg Bid

Drug: Prednisone
prednisone 10mg Qd




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meet the 2006 Wingerchuk diagnostic criteria;
  • NMO-immunoglobulin G seropositive;
  • Between 18 to 65 years old;
  • Relapse: more than 2 relapses in recent 2 years; more than 1 relapses in recent 1 years;
  • Expanded disability status scale: expanded disability status scale≤7.0, and visual acuity ≥20 / 100 at least in one eye
  • Understand the purpose and procedures of this study, and written informed consent is obtained.

Exclusion Criteria:

  • Using immunosuppressive agents and other drugs affect evaluation, and drug withdrawal less than 3 months;
  • Patients with any of the following diseases: transaminases elevation exceed 2 times of the normal upper limit; white blood cell <4 × 109 / L, Hemoglobin <80g / L, platelet <100 × 109 / L;
  • With serious cardiovascular, liver, kidneys and other vital organs and blood, endocrine system diseases, cancer history;
  • With immunodeficiency, uncontrolled infection and active gastrointestinal diseases (such as gastric ulcer, etc.);
  • Pregnancy, breast-feeding women and male or female who plans to conceive recently;
  • Allergy to mycophenolate mofetil and prednisone.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02809079


Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
Zhongshan Ophthalmic Center, Sun Yat-sen University
Southern Medical University, China
Investigators
Layout table for investigator information
Principal Investigator: Wei Qiu, Medical PhD Third Affiliated Hospital, Sun Yat-Sen University

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Wei Qiu, Associate Professor, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02809079     History of Changes
Other Study ID Numbers: 2016017
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: June 22, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: share by publications and meetings

Additional relevant MeSH terms:
Layout table for MeSH terms
Mycophenolic Acid
Disease
Neuromyelitis Optica
Pathologic Processes
Myelitis, Transverse
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Demyelinating Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action