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Safety and efficacy of tocilizumab in the treatment of recurrent optic neuritis

Safety and efficacy of tocilizumab in the treatment of recurrent optic neuritis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045273
Enrollment
Unknown
Registered
2021-04-10
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-11-16

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

Conditions

recurrent optic neuritis

Interventions

experimental group: tocilizumab

Sponsors

Department of Ophthalmology, PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Meet the diagnostic criteria of optic neuritis as defined by ONTT, and the serum AQP4-Ab or MOG-Ab was positive by CBA assay; 2.Patients with recurrent ON (recurrence was defined as visual loss at least 2 lines as measured by standard logarithmic acuity chart after standardized use of AZA/MMF/RTX, and supported by imaging evidence: enhanced in orbital MRI); 3.18 years old <= age <= 65 years old; 4.No gender limitation; 5.Willing to comply with the test program, and voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating women; 2.Those who are allergic to any ingredient in the test drug; 3.Patients with severe cardiovascular, liver, kidney or hematopoietic diseases, diabetes, and blood pressure >= 140/90 mmHg; 4.There is a history of using other DMT drugs in the past six months: such as interferon, natalizumab, FTY-720, etc.; 5.Those who have participated in clinical trials of other new drugs in the last 3 months; 6.Those who cannot complete the research according to the clinical trial protocol due to severe mental or language barriers; 7.The investigator believes that it is not suitable to participate in this clinical trial due to other reasons.

Design outcomes

Primary

MeasureTime frame
Interval of disease recurrence;

Secondary

MeasureTime frame
Visual acuity changes;The changes of retinal optic nerve fiber layer thickness;The changes of ganglion cells in macular area;Variation of visual field;

Countries

China

Contacts

Public ContactZhou Huanfen

PLA General Hospital

zhouzhoueye@163.com+86 13699138182

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026