recurrent MOG Antibody-Associated Optic Neuritis
Conditions
Interventions
Treatment group:Subcutaneous injection of secukinumab, 300mg (for children < 50kg,150mg), once each in weeks 0 and 2, and once a month starting from week 4.
Control group:Oral Mycophenolate mofetil Dispersible tablets, 750mg, 2 times a day (500-750mg per body surface area for children, taken orally in two divided doses)
Sponsors
Chinese People’s Liberation Army General Hospital
Eligibility
Sex/Gender
All
Age
6 Years to 65 Years
Inclusion criteria
Inclusion criteria: The diagnostic criteria for Optic Neuritis in the Optic Neuritis Treatment Trial (ONTT) were met, and the positive serum MOG-Ab was confirmed by the cell-based assay (CBA) method. At the same time, subjects must meet all of the following conditions to be enrolled: Patients with recurrent ON who have had at least one recurrence within the 12 months prior to enrollment. 2.6 years old <= age <= 65 years old; 3. Gender is not limited; 4. Be willing to comply with this trial protocol and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Age 65 years; 2.Pregnant or lactating women; 3.History of hypersensitivity to any component of the investigational product; 4.Severe cardiovascular, hepatic, renal, or hematological disorders; diabetes mellitus; or blood pressure >=140/90 mmHg; 5.Use of other immunosuppressive or immunomodulatory agents (e.g., tacrolimus, azathioprine) within the past 6 months; 6.Prior rituximab use with serum CD19+ B-cell count not recovered to >1% and interval since last dose <6 months; 7.Participation in other clinical trials of investigational drugs within the past 3 months; 8.Active hepatitis B virus (HBV) infection; 9.Severe psychiatric or language disorders that would preclude compliance with the clinical trial protocol; 10.Any other condition deemed by the investigator to render the subject unsuitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to First Clinical Relapse within 48 Weeks(TFR);Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Annualized relapse rate (ARR);Best-corrected visual acuity;The thickness of the perioptic disc nerve fiber layer (pRNFL);Vision VFI, MD, and PSD;The thickness of ganglion cells and inner plexiform layer (mGCIPL) in the macular area;EDSS score;The number of active lesions as shown by MRI; | — |
Countries
China
Contacts
Public ContactZhou Huanfen
Chinese People’s Liberation Army General Hospital
Outcome results
None listed