Actively Recruiting
Therapy in the Acute Phase of NMOSD: A Multicenter Prospective Real-World Study
Led by Chinese PLA General Hospital · Updated on 2026-03-12
200
Participants Needed
1
Research Sites
177 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This project is a multi-center, prospective, real-world cohort study that collects clinical data of Chinese patients with AQP4-positive NMOSD in the acute stage. It comprehensively assesses the clinical outcomes of the patients and aims to compare the clinical efficacy and safety of icoxib as a combined add-on treatment versus simple hormone shock therapy during the acute phase of NMOSD.Using simple hormone shock therapy (IVMP) as the control group, the efficacy and safety of etanercept treatment in the acute attack phase of Chinese patients with AQP4-positive neuromyelitis optica spectrum disorder (NMOSD) were evaluated.
CONDITIONS
Official Title
Therapy in the Acute Phase of NMOSD: A Multicenter Prospective Real-World Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years old, any gender
- Diagnosis of NMOSD according to 2015 International Panel for NMO Diagnosis (IPND) criteria with positive serum AQP4-IgG
- Acute phase of NMOSD optic neuritis (ON) with new or worsening optic nerve dysfunction within 21 days and confirmed optic nerve damage on imaging
- Best corrected visual acuity during acute NMOSD-ON drops from above 0.3 to 0.1 or less
- Acute phase of NMOSD transverse myelitis (TM) with new or worsening spinal cord dysfunction within 21 days and confirmed spinal cord damage on imaging
- EDSS score during acute NMOSD-TM increases from 4.0 or less to 6.0 or more
- Clinical onset and recurrence confirmed unanimously by center and committee
- Agreement to receive meningococcal vaccine or use eculizumab during and 2 weeks after treatment
- Signed informed consent form
You will not qualify if you...
- Optic nerve or spinal cord damage caused by factors other than NMOSD
- Abnormal lab results including neutrophils below 1.5 x 10^9/L, hemoglobin below 90g/L, platelets below 75 x 10^9/L
- Kidney or liver function tests above specified limits or GFR below 60 mL/min/1.73m2
- HbA1c above 8% in diabetic patients
- Pregnant or breastfeeding women or those planning pregnancy during the study
- Received certain immunotherapies (PE/IA/IVIG/FcRn/B-cell deletion/C5/IL-6) within 1 month before enrollment
- Active infections such as hepatitis B or C, syphilis, HIV, meningococcal infection, or severe infections preventing immunosuppressive use
- Severe internal or external diseases including heart failure, unstable angina, respiratory failure, cachexia, organ transplant
- Untreated or uncontrolled malignant tumors
- Serious physical or mental illness affecting study participation
- Known allergy to monoclonal antibodies, murine proteins, or excipients
- Intolerance to methylprednisolone or gamma globulin
- Inability to complete enhanced MRI screening
- Participation in other interventional clinical trials
- Inability to understand or cooperate with questionnaires
- Any other condition deemed unsuitable by the research team
AI-Screening
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Trial Site Locations
Total: 1 location
1
the First Medical Center of Chinese PLA General Hospital
Beijing, China
Actively Recruiting
Research Team
D
Dehui huang, Doctoral degree
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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