Skip to content

A Prospective Study on the Efficacy andSafety of Rituximab in Treatment for Neuromyelitis Optica associated Optic Neuritis

A Prospective Study on the Efficacy andSafety of Rituximab in Treatment for Neuromyelitis Optica associated Optic Neuritis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-ICR-15007177
Enrollment
Unknown
Registered
2014-05-30
Start date
2014-08-30
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromyelitis Optica associated Optic Neuritis

Interventions

1:Intravenous 100mg Rituximab, 1/week*4
2:Oral azathioprine (2.5-3 mg/kg bodyweight/day) or mycophenolate mofetil (1000-1500mg/day)

Sponsors

The Ophthalmology Department of the Chinese Peoples Liberation Army Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for NMO-ON (fulfill one of following criteria: (1) Meet the Wingerchuk 2006 diagnostic criteria for NMO; (2) Recurrent ON or first-episode bilateral simultaneous ON meeting the ONTT diagnostic criteria for ON, andwith positive AQP4-Ab and/or NMO-IgG in blood and/or cerebral-spinal fluid, 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 andsigned informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Allergic to Rituximab or mouse protein; 3. Abnormal cardiovascular, liver, or hematopoietic function; patients with diabetes or blood pressure >140/90 mmHg; 4. The medication of other disease mediated treatment (interferon, natalizumab, FTY-720, etc.) within 6 months; 5. Participant in other clinical trials; 6. Severe mental or language disorder; 7. Other inadvisable reasons for this research.

Design outcomes

Primary

MeasureTime frame
EDSS score;Best Corrected Visual Acuity;Annual Relapse Rate;

Secondary

MeasureTime frame
Visual Field;Visual Evoked Potential;Para-Optic Disc andMacular Retinal Nerve Fiber Layer Thickness (Optical Coherence Tomography);Length of Spinal Lesion (Magnetic Resonance Imaging);

Countries

China

Contacts

Public ContactShihui Wei
rtxnmoon@163.com+86 13910079431

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026