Efgartigimod in Acute Neuromyelitis Optica Spectrum Disorders

Launched by FENG JINZHOU · Nov 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Efgartigimod for people with acute Neuromyelitis Optica Spectrum Disorders (NMOSD). NMOSD is a rare autoimmune disease that affects the nervous system, and this trial aims to see how safe and effective Efgartigimod is for patients experiencing a sudden worsening of their symptoms. The trial will include adults aged 18 and older who have a specific type of NMOSD and have not responded well to other treatments. Participants must have new or worsened symptoms in the last 30 days and meet certain health criteria.

If you or a loved one is considering this trial, you should know that participation involves some specific requirements. For example, eligible participants should not have received certain other treatments like plasma exchange in the month before joining the study. Those who are pregnant or have certain health conditions may not be able to participate. If accepted, participants will receive Efgartigimod and will be closely monitored for its effects on their symptoms and overall health. This trial is not yet recruiting, but it hopes to provide valuable insights into how Efgartigimod can help manage acute NMOSD.

Gender

ALL

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. Patients in the acute phase of NMOSD (definition of acute phase: new neurological symptoms or aggravation of existing symptoms within 30 days before received treatment, lasting at least 24 hours without fever), who had poor response to IVMP and without having received second-line therapies such as plasma exchange or intravenous immunoglobulin consequencely (Poor response is defined as a reduction in EDSS score of: I. \<1.0 from the baseline EDSS score when the baseline score was \<=5.5 II. \< 0.5 when the baseline EDSS score \> 5.5).
• • 3. Patients who were approved for Efgartigimod treatment would be enrolled in the exposed group.
• • 4. Expanded disability status scale (EDSS) score ≤ 8 and ≥ 2.5 before treatment.
• • 5. Patients have given their written informed consent.
• Exclusion Criteria:
• • 1. Lactating and pregnant females before treatment.
• • 2. Participated in other interventional studies within 30 days before treatment.
• • 3. Received plasma exchange, immunoadsorption, or intravenous immunoglobulin (IVIG） therapy within 1 month before treatment.
• • 4. History of malignancies.
• • 5. Combined with severe mental disorders and other conditions that unable to cooperate with follow-up.
• • 6. After being evaluated by experts, patients with active hepatitis, active tuberculosis, or other special conditions which were ineligible to participate in this study.