Clinical trial NCT05891379: Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders
Official title: Effectiveness and Safety of Inebilizumab in the Acute Phase of Neuromyelitis Optica Spectrum Disorders-a Multicentric, Prospective, Real Word Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuromyelitis Optica Spectrum Disorder
Keywords: Neuromyelitis Optica Spectrum Disorder
inebilizumab
observational study
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2023-06-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NMOSD patients with acute attacks

Brief summary: This study is aimed to observe the effectiveness and safety of inebilizumab in the acute phase of neuromyelitis optica spectrum disorders.

Detailed description: This is a a multicentric, prospective, real word study of inebilizumab in NMOSD acute attack compared with oral immunosuppressant. A total of 50 patients will be enrolled at approximately 10 centers around China.

Eligibility criteria: Inclusion Criteria:

* 1. Age ≥ 18 years with anti-AQP4-IgG seropositive NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis); 2. In the acute phase of NMOSD (definition of acute phase: new neurological symptoms or aggravation of existing symptoms within 30 days before screening, lasting at least 24 hours without with fever); 3. Patients who plan to receive or are receiving intravenous methylprednisolone therapy; 4. Expanded disability status scale (EDSS) score ≤ 8 and ≥ 2.5 during the screening period; 5. Able and willing to give written informed consent; 6. Women of childbearing potential who agree to use adequate contraception during the study.

Exclusion Criteria:

* 1. Lactating and pregnant females; 2. Participate in other interventional studies within 30 days before screening or within 5 half-lives of the investigational agent before enrollment; 3. Combined with severe mental disorders and other conditions and unable to cooperate with follow-up; 4. History of malignancies; 5. Received plasma exchange, immunoadsorption or intravenous immunoglobulin therapy within 1 month before screening; 6. Patients with negative hepatitis B surface antibody (HBsAg) and positive hepatitis B core antibody (HBcAb), or HBsAg-positive virus carriers, or patients with active tuberculosis or positive tuberculosis screening without appropriate treatment history; 7. Other situations that researchers think are not suitable to participate in this study.

Primary outcomes:
measure: Change in Expanded Disability Status Scale (EDSS) score from baseline
timeFrame: 6 months
Secondary outcomes:
measure: Change in Expanded Disability Status Scale (EDSS) score from baseline
timeFrame: 1 months, 3 months
measure: Percentage of Participants With Disability Improvement
timeFrame: 6 months
measure: Change in modified Rankin score (mRS) from baseline
timeFrame: 1 months, 3 months, 6 months
measure: Time to first relapse
timeFrame: 6 months
measure: Number of New, and/or Enlarging T2 Hyperintense Lesions Detected by Magnetic Resonance Imaging (MRI)
timeFrame: 6 months
measure: Change in Timed 25 Foot Walk Test from baseline
timeFrame: 1 months, 3 months , 6 months
measure: Number of NMOSD attacked related rescue treatment
timeFrame: 6 months
measure: Change in serum GFAP levels from baseline
timeFrame: 6 months
measure: Change in AQP4-ab titers from baseline
timeFrame: 6 months
measure: Change in Low-contrast Visual Acuity (LCVA) from baseline
timeFrame: 3 months, 6 months
measure: Changes in EQ-5D-5L scores from baseline
timeFrame: 1 month, 3 months ,6 months
measure: Change in retinal nerve fiber layer (RNFL) loss from baseline
timeFrame: 3 months ,6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Junwei Hao, MD
role: PRINCIPAL_INVESTIGATOR
References: