Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorders
Conditions
Keywords
mitoxantrone, neuromyelitis optica, relapse
Brief summary
The treatment protocol consisted of 12 mg/m2 MITO intravenous infusions every 3 months for 2 years. Dosage was adjusted according to side effects. Neurological assessment including the determination of the Expanded Disability Status Scale (EDSS) score and ophthalmologic evaluations were performed every 3 months and during relapses. Flow cytometric analysis, brain and spinal cord MRI was performed at baseline, 6, 12, 18, and 24 months.
Interventions
DRUGMitoxantrone
The treatment protocol consisted of 12 mg/m2 MITO intravenous infusions every 3 months for 2 years. Dosage was adjusted according to side effects.
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Recurrent longitudinal myelitis (\>3 segments of spinal cord involvement by MRI) with or without recurrent ON (unilateral or bilateral) but with normal brain MRI and positive serological NMO IgG antibody. * Recurrent longitudinal myelitis (\>3 segments of spinal cord involvement by MRI) with or without spatially limited brain lesion and positive serological NMO IgG antibody. * NMO, fulfilled Wingerchuk 2006 Criteria for NMO. * Patient presented at least 2 relapses during the 12 months preceding the start of mitoxantrone therapy, despite immunotherapies using corticosteroid, interferon beta, azathioprine, cyclophosphamide, Cyclosporin A, Mycophenolate Mofetil or a combination of these drugs * Extended Disability Status Score 3-8. * Normal range for white-blood-cell count (more than 4×109/L), neutrophil count (more than 2×109/L), and platelet count (more than 100×109/L).
Exclusion criteria
* Cardiac risk factors (e.g history of congestive heart failure and left ventricular ejection fraction (LVEF) \< 50% * Systemic diseases such as lupus, Sjogren's syndrome, anti-phospholipid antibody syndrome, sarcoidosis, rheumatoid arthritis, or vitamin B12 deficiency * Previous treatment with mitoxantrone or anthracyclines * Pregnant or planning to be pregnant * Patients with severe liver disorders (WHO grade 4)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| annual relapse rate (ARR) | one year | ARR is defined as the number of confirmed relapses in a year. The number of annual relapse rate was used as parameters of effectiveness and was compared between premitoxantrone and postmitoxantrone treatment during the follow-up period. |
| EDSS | six months | Expanded Disability Status Scale (EDSS) scores was used as parameters of effectiveness and was compared between premitoxantrone and postmitoxantrone treatment during the follow-up period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in LVEF | six months | \- Assessment of cardiac function: Changes in LVEF by transthoracic echocardiography and determination of cardiac side effects by ECG and by measurement of CK-MB, Troponin and BNP. |
| blood cell count | three months | \- Assessment of hematological system: Monitoring blood cell count regularly. Considering marrow puncture if necessary. |
| Flow cytometric analysis | six months | Immunofluorescent staining of wholeblood samples were performed of blood drawing using antibodies against CD3/CD4/CD8/CD19/CD20/CD56 with isotype controls, followed by lysis of red blood cells and immediate acquisition and analysis by flow cytometry. |
Countries
China
Contacts
Primary ContactHuiqing Dong, Doctor
Backup ContactZheng Liu, Doctor
Outcome results
None listed