Observing the effects of inebilizumab in acute neuromyelitis optica spectrum disorders
Effectiveness and Safety of Inebilizumab in the Acute Phase of Neuromyelitis Optica Spectrum Disorders-a Multicentric, Prospective, Real Word Study
This study is testing if inebilizumab is a safe and effective treatment for people with acute symptoms of neuromyelitis optica spectrum disorders compared to those taking oral immunosuppressants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Drugs / interventions | inebilizumab |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05891379 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness and safety of inebilizumab during acute attacks of neuromyelitis optica spectrum disorders (NMOSD). It is a multicentric, prospective study involving approximately 50 patients across 10 centers in China. Participants will be compared to those receiving oral immunosuppressants, with a focus on real-world outcomes. The study will include patients who are anti-AQP4-IgG seropositive and experiencing acute symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with anti-AQP4-IgG seropositive NMOSD in the acute phase.
Not a fit: Patients who are pregnant, lactating, or have severe mental disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into a more effective treatment option for patients experiencing acute NMOSD attacks.
How similar studies have performed: While this approach is observational, similar studies have shown promise in evaluating treatments for NMOSD, suggesting potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Xuanwu Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Junwei Hao, MD — Xuanwu Hospital, Beijing
- Study coordinator: Junwei Hao, MD
- Email: haojunwei@vip.163.com
- Phone: 010-83198277
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.