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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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30 September 2019 |
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Main ID: |
ChiCTR1900025744 |
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Date of registration:
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2019-09-07 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical effectiveness and safety of Rituximab (Henlius) for optic neuritis secondary to neuromyelitis optica spectrum disorder: a pilot clinical trial
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Scientific title:
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Clinical effectiveness and safety Rituximab (Henlius) for optic neuritis secondary to neuromyelitis optica spectrum disorder: a pilot clinical trial |
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Date of first enrolment:
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2019-09-01 |
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Target sample size:
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1:30;2:30; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=43058 |
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Study type:
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Observational study |
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Study design:
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Non randomized control
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Phase:
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4
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Countries of recruitment
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China
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Contacts
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Name:
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Lindan Xie
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Address:
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28 Fuxing Road, Haidian District, Beijing, China
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Telephone:
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+86 13691212816 |
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Email:
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Lindanevers@163.com |
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Affiliation:
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The General Hospital of Chinese Peoples Liberation Army |
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Name:
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Shihui Wei
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Address:
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28 Fuxing Road, Haidian District, Beijing, China
100853
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Telephone:
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+86 13910079431 |
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Email:
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weishihui706@hotmail.com |
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Affiliation:
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The General Hospital of Chinese Peoples Liberation Army |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Meet the diagnostic criteria for NMO-ON (fulfill one of following criteria:
(1) Meet the international consensus diagnostic criteria for NMOSD Proposed by the international panel for NMO diagnosis in 2015;
(2) Recurrent ON or first-episode unilateral or bilateral ON secondary to NMOSD with AQP4-Ab and/or NMO-IgG seropositive, testing by both cell-based assay andenzyme-linked immunosorbent assay);
2. Aged from 18 to 70 years;
3. Agreed with the protocol for this study and signed informed consent.
Exclusion criteria: 1. During the Pregnancy or breastfeeding;
2. Allergic to any ingredient of Rituximab or AZA/MMF; or respiratory system infection is not suitable for use of this drug;
3. Patients with severe cardiovascular, liver, kidney or hematopoietic diseases or diabetes, with blood pressure >=140/90 mmHg;
4. History of application of other DMT drugs (e.g. Interferon, natalizumab, FTY-720, etc.) or injected imported rituximab in the last half-year;
5. Participated in clinical trials of other new drugs within the last 3 months;
6. Cannot complete the clinical trial protocol or cannot meet follow-up requirements due to severe mental or language disorders;
7. The researcher thinks that it is inappropriate to participate in the clinical trial due to other reasons; Or do not agree to participate in this research project.
Age minimum:
18
Age maximum:
70
Gender:
Both
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Health Condition(s) or Problem(s) studied
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neuromyelitis optica spectrum disorder (NMOSD)
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Intervention(s)
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1:Intravenous 200mg Rituximab, 1/week*2, if the proportion of CD19+ B lymphocytes in peripheral blood is above 1% then repeat administration (200mg);2:Oral azathioprine (2.5-3 mg/kg bodyweight/day) or mycophenolate mofetil (750~3000mg/day);
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Primary Outcome(s)
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Annual Relapse Rate;Best Corrected Visual Acuity;EDSS score;side effects;
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Source(s) of Monetary Support
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funded by the National Natural Science Fundation of China (NO.81870662)
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Ethics review
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Status: Approved
Approval date: 25/07/2019
Contact:
010-66937166
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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