Switching from Conventional Immunosuppressants to Inebilizumab for the Treatment of Neuromyelitis Optica Spectrum Disorder

Evaluation of the Efficacy of Switching from Conventional Immunosuppressants to Inebilizumab for Patients with Neuromyelitis Optica Spectrum Disorder: A Multicenter Real-World Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2400091194

Enrollment

Unknown

Registered

2024-10-23

Start date

2024-10-31

Completion date

Unknown

Last updated

2024-10-28

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

Conditions

Neuromyelitis optica spectrum disorders

Interventions

Observations:None

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or older, with no gender restrictions; 2. Patients who are AQP4-IgG positive according to the 2015 diagnostic criteria for NMOSD; 3. Have previously used conventional immunosuppressants to prevent relapses of NMOSD; 4. Have switched to or plan to switch to treatment with Inebilizumab; 5. Patients have a full understanding of the trial content, process, and possible adverse reactions, and have signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with active hepatitis B virus infection; 2. Patients with active or untreated latent tuberculosis; 3. Patients who the investigator judges may be allergic to Inebilizumab; 4. Other patients whom the investigator deems unsuitable for inclusion in this study.

Design outcomes

Primary

Measure	Time frame
The percentage of NMOSD patients with relapses determined by the investigator within the first year after switching medication;	—

Secondary

Measure	Time frame
Reasons for switching to Inebilizumab treatment.;Annualized Relapse Rate after medication switch;Change in patient's Expanded Disability Status Scale score compared to baseline;Change in patient's visual acuity in both eyes after medication switch;Change in Hauser ambulation score compared to baseline ;Change in AQP4 antibody titer after medication switch compared to baseline;Number of days of corticosteroid co-administration during the first year of Inebilizumab treatment;Number of days of conventional immunosuppressant co-administration during the first year of Inebilizumab treatment;Proportion of missed doses of Inebilizumab;Proportion of patients with 100% adherence to treatment ;Proportion of subjects who discontinue treatment due to insufficient efficacy or tolerability/safety reasons during the study period;	—

Measure

Time frame

Reasons for switching to Inebilizumab treatment.;Annualized Relapse Rate after medication switch;Change in patient's Expanded Disability Status Scale score compared to baseline;Change in patient's visual acuity in both eyes after medication switch;Change in Hauser ambulation score compared to baseline ;Change in AQP4 antibody titer after medication switch compared to baseline;Number of days of corticosteroid co-administration during the first year of Inebilizumab treatment;Number of days of conventional immunosuppressant co-administration during the first year of Inebilizumab treatment;Proportion of missed doses of Inebilizumab;Proportion of patients with 100% adherence to treatment ;Proportion of subjects who discontinue treatment due to insufficient efficacy or tolerability/safety reasons during the study period;

—

Countries

China

Contacts

Public ContactQiu Wei

The Third Affiliated Hospital, Sun Yat-sen University

qiuwei@mail.sysu.edu.cn+86 158 9996 8330

Outcome results

None listed

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