Ofatumumab for the treatment of optic neuritis associated with neuromyelitis optica spectrum disorder

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400086835

Enrollment

Unknown

Registered

2024-07-11

Start date

2022-10-10

Completion date

Unknown

Last updated

2024-07-15

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

Conditions

optic neuritis associated with neuromyelitis optica spectrum disorder

Interventions

treatment group:hypodermic injection(the individual group accept 20mg ofatumumab subcutaneously once a week in week 0, week 2 of the first month, and the B lymphocyte subsets were detected every month

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age: 18 to 65 years old (2) Serum Aquaporin-4 antibody (AQP-4 antibody) was positive (3)Patients had at least two recurrences in the 2 years before screening or at least one recurrence in the past 12 months (4)The Extended Disability Status Scale (EDSS) score at screening had to be 0 to 7.0 (on a scale of 0 to 10, with 0 indicating no disability and 10 indicating death). (5) no gender limitation; (6) Willing to obey the trial protocol and sign informed consent voluntarily.

Exclusion criteria

Exclusion criteria: (1)Age 65 years; (2) pregnant and lactating women; (3) Allergic to any component of the test drug; (4) patients with severe cardiovascular, hepatic, renal or hematopoietic diseases, diabetes mellitus, and blood pressure =140/90 mmHg; (5) other immunosuppressive and immunomodulatory drugs used within the past six months, such as mycophenolate mofetil, tacrolimus, azathioprine, etc. (6) serum CD19+B cell counts did not recover to more than 1% in patients previously treated with rituximab, and the interval between the last administration of rituximab was less than 6 months; (7) those who participated in clinical trials of other new drugs within the past 3 months; (8) active Hepatitis B virus (HBV) infection; (9) unable to complete the study according to the clinical trial protocol due to severe mental or language impairment; (10) those who were considered by the investigators to be unfit to participate in the trial for other reasons.

Design outcomes

Primary

Measure	Time frame
annualized relapse rate, ARR;	—

Secondary

Measure	Time frame
Best corrected visual acuity, BCVA;pRNFL;mGCIPL;recurrence-free survival, RFS;	—

Countries

China

Contacts

Public ContactShihui Wei

Chinese PLA General Hospital & Chinese PLA Medical School

weishihui706@hotmail.com+86 198 0020 7382

Outcome results

None listed

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